The long-term efficacy and safety of fluocinolone acetonide intravitreal implant 190 µg (ILUVIEN®) in diabetic macular oedema in a multi-ethnic inner-city population.

PURPOSE: The purpose of this study is to report the long-term efficacy and safety of 0.19 mg fluocinolone acetonide intravitreal implant (ILUVIEN®) in pseudophakic eyes with diabetic macular oedema in a multi-ethnic patient cohort. METHODS: This is a single-centre retrospective analysis of patients with persistent diabetic macular oedema, despite previous anti-vascular endothelial growth factor and/or steroid treatment, treated with the ILUVIEN implant according to national guidelines. Patients with follow-up of less than 24 months were excluded. Best corrected visual acuity, central retinal thickness and intraocular pressure were evaluated at baseline and month 3, 12, 24 and 36 post-treatment. A sub-group analysis was performed on eyes with 36-month follow-up data. RESULTS: In total, 24 eyes (24 patients) completed at least 24 months of follow-up, of which 9 completed 36 months of follow-up. Three-fourths of the patients were black or South Asian (blacks, Asians and minority ethnic). Improvement in mean best corrected visual acuity was seen at year 1 and year 3 improving from 0.62 LogMAR at baseline to 0.55 LogMAR at year 1 and 0.47 LogMAR at year 3 (all p > 0.05). Mean central retinal thickness also showed a progressive reduction from 471 µm at baseline to 397 µm at year 1 and 339 µm at year 3 (all p < 0.05). Four eyes required intraocular pressure-lowering drops post-implant. Supplementary treatment for persistent or recurrent diabetic macular oedema was necessary in 13 eyes over the total study period of 3 years. Blacks, Asians and minority ethnic patients had a worse response compared with white patients. CONCLUSION: The ILUVIEN implant was effective and safe in the treatment of multi-ethnic patients with diabetic macular oedema refractory to conventional therapies, improving the vision and macular anatomy, without significant adverse events up to 36 months post-treatment.

The Impact of Race on Short-term Treatment Response to Bevacizumab in Diabetic Macular Edema.

PURPOSE: To determine the impact of race and ethnicity on efficacy of intravitreal bevacizumab for diabetic macular edema in anti-vascular endothelial growth factor (VEGF) treatment-naive patients. DESIGN: Retrospective cohort study. METHODS: Setting: Urban-based academic institution with affiliated private offices. STUDY POPULATION: Intravitreal anti-VEGF naïve patients seen between 2010 and 2019 of White (W) race, Black (B) race, or Hispanic (H) ethnicity aged 18 years and older with diabetic macular edema who received intravitreal injections of bevacizumab. Exclusion criteria were prior intravitreal anti-VEGF treatment, invasive ophthalmologic interventions, and laser treatments within 3 months prior to first injection through the duration of the study. Exposures: Intravitreal bevacizumab. MAIN OUTCOMES MEASURES: Percentage of patients with visual acuity (VA) improvement and mean percentage reduction in central macular thickness (CMT). RESULTS: Percentage with VA improvement was 27% vs 39% vs 50% after 1 injection (n = 314), and 34% vs 55% vs 59% after 3 injections (n = 150) for B, H, and W cohorts, respectively. Black patients experienced lower odds of VA improvement compared with White and Hispanic patients after 1 injection (odds of 0.480, CI 0.284-0.814, P = .006) and 3 injections (odds of 0.342, CI 0.149-0.782, P = .008) while controlling for age, sex, baseline glycated hemoglobin (HbA1c), baseline CMT, baseline VA, laser history, injection time course, and follow-up delay. CONCLUSIONS: Black patients had a significantly lower likelihood of visual acuity improvement following intravitreal bevacizumab treatment compared with White and Hispanic patients. Further research is warranted to understand the effect of race and ethnicity on anti-VEGF efficacy to ensure optimal treatment for each individual.

Characteristics, Upon Presentation, of a Cohort of Hispanic Patients with Birdshot Retinochoroidopathy.

OBJECTIVE: To describe the characteristics, upon presentation, of a cohort of Hispanic patients with birdshot retinochoroidopathy. METHODS: A retrospective chart review of Hispanic patients with birdshot retinochoroidopathy of was performed. The demographic and clinical characteristics were analyzed. RESULTS: Nine patients who met the research criteria for a diagnosis of birdshot retinochoroidopathy were identified and included in the analysis, all of whom were HLA-A29 positive. The median age of the cohort upon presentation was 52 years; 89% of the patients were female, and all were Hispanics. Ninety-four percent of the eyes had an initial visual acuity of 20/50 or better, while 72% had measured 20/25 or better. Sixty-one percent of the eyes had retinal vasculitis, which was bilateral in 83% of the cases. Thirty-three percent of the patients had, upon presentation, evidence of cystoid macular edema, which was always bilateral. All the eyes had the typical birdshot lesions, at presentation. CONCLUSION: Birdshot retinochoroidopathy can be found in Hispanic patients. Our study suggests that the characteristics upon presentation in Hispanics may be similar to those of Caucasian cohorts.

Prevalence of diabetic retinopathy and diabetic macular edema in a primary care-based teleophthalmology program for American Indians and Alaskan Natives.

BACKGROUND: Diabetes and its complications are more common in American Indians and Alaska Natives (AI/AN) than other US racial/ethnic populations. Prior reports of diabetic retinopathy (DR) prevalence in AI/AN are dated, and research on diabetic macular edema (DME) is limited. This study characterizes the recent prevalence of DR and DME in AI/AN using primary care-based teleophthalmology surveillance. METHODS: This is a multi-site, clinic-based, cross-sectional study of DR and DME. The sample is composed of AI /AN patients with diabetes (n = 53,998), served by the nationally distributed Indian Health Service-Joslin Vision Network Teleophthalmology Program (IHS-JVN) in primary care clinics of US Indian Health Service (IHS), Tribal, and Urban Indian health care facilities (I/T/U) from 1 November 2011 to 31 October 2016. Patients were recruited opportunistically for a retinal examination using the IHS-JVN during their regular diabetes care. The IHS-JVN used clinically validated, non-mydriatic, retinal imaging and retinopathy assessment protocols to identify the severity levels of non-proliferative diabetic retinopathy (NPDR), proliferative diabetic retinopathy (PDR), DME, and sight threatening retinopathy (STR; a composite measure). Key social-demographic (age, gender, IHS area), diabetes-related health (diabetes therapy, duration of diabetes, A1c), and imaging technology variables were examined. The analysis calculated frequencies and percentages of severity levels of disease. RESULTS: Prevalence of any NPDR, PDR, DME, and STR among AI/AN patients undergoing DR teleophthalmology surveillance by IHS-JVN was 17.7%, 2.3%, 2.3%, and 4.2%, respectively. Prevalence was lowest in Alaska and highest among patients with A1c >/ = 8%, duration of diabetes > 10 years, or using insulin. CONCLUSIONS: Prevalence of DR in this cohort was approximately half that in previous reports for AI/AN, and prevalence of DME was less than that reported in non-AI/AN populations. A similar reduction in diabetes related end-stage renal disease in the same population and time period has been reported by other researchers. Since these two diabetic complications share a common microvasculopathic mechanism, this coincident change in prevalence may also share a common basis, possibly related to improved diabetes management.

Ethnic Differences in the Prevalence and Risk Factors of Diabetic Retinopathy: The Singapore Epidemiology of Eye Diseases Study.

PURPOSE: To evaluate the prevalence and risk factors for diabetic retinopathy (DR) in the Singapore Epidemiology of Eye Diseases (SEED) Study. DESIGN: Population-based, cross-sectional study. PARTICIPANTS: Persons of Malay, Indian, and Chinese ethnicity aged 40+ years, living in Singapore. METHODS: Diabetes was defined as nonfasting plasma glucose ≥200 mg/dl (11.1 mmol/l), glycated hemoglobin A1c (HbA1c) >6.5%, self-reported physician-diagnosed diabetes, or the use of glucose-lowering medication. Retinal photographs, were graded for the presence and severity of DR using the modified Airlie House classification system. MAIN OUTCOME MEASURES: Diabetic retinopathy, diabetic macular edema (DME), vision-threatening diabetic retinopathy (VTDR), defined as the presence of severe nonproliferative or proliferative DR, or clinically significant macular edema (CSME). RESULTS: Of the 10 033 subjects, 2877 (28.7%) had diabetes and gradable photographs for analysis. The overall age-standardized prevalence (95% confidence interval [CI]) was 28.2% (25.9-30.6) for any DR, 7.6% (6.5-9.0) for DME, and 7.7% (6.6-9.0) for VTDR. Indians had a higher prevalence of any DR (30.7% vs. 26.2% in Chinese and 25.5% in Malays, P = 0.012); a similar trend was noted for any DME (P = 0.001) and CSME (P = 0.032). Independent risk factors for any DR were Indian ethnicity (odds ratio [OR], 1.41; 95% CI, 1.09-1.83, vs. Chinese), diabetes duration (OR, 1.10; 95% CI, 1.08-1.11, per year), HbA1c (OR, 1.25; 95% CI, 1.18-1.32, per %), serum glucose (OR, 1.03; 95% CI, 1.00-1.06, per mmol/l), and systolic blood pressure (OR, 1.14; 95% CI, 1.09-1.19, per 10 mmHg). Diastolic blood pressure (OR, 0.74; 95% CI, 0.65-0.84, per 10 mmHg increase), total cholesterol (OR, 0.87; 95% CI, 0.80-0.95, per mmol/l increase), and low-density lipoprotein (LDL) cholesterol (OR, 0.83; 95% CI, 0.74-0.92, per mmol/l increase) were associated with lower odds of any DR. Risk factors were largely similar across the 3 ethnic groups. CONCLUSIONS: Indian Singaporeans have a higher prevalence of DR and DME compared with Chinese and Malays. Major risk factors for DR in this study were similar across the 3 ethnic groups. Addressing these risk factors may reduce the impact of DR in Asia, regardless of ethnicity.

Association Between Perceived Barriers to Diabetes Self-management and Diabetic Retinopathy in Asian Patients With Type 2 Diabetes.

Importance: A patient's perceived barriers to diabetes self-management (DSM) may affect his or her risk of diabetic retinopathy (DR); however, few studies have examined this association. Objective: To examine the association between perceived barriers to DSM and the severity spectrum of DR in Asian patients with type 2 diabetes. Design, Setting, and Participants: A cross-sectional clinic-based study, the Singapore Diabetes Management Project, was conducted from December 28, 2010, to March 20, 2013, at the Singapore National Eye Centre, a tertiary eye care institute. After excluding patients with type 1 diabetes and ungradable fundus images, 361 participants were included in the analyses. Statistical analysis was conducted from July 20 to September 8, 2017. Exposure: The degree of perceived barriers to DSM was assessed using a 23-item questionnaire comprising items about knowledge of DSM, access to care, and confidence in health care professionals. Rasch analysis was used to optimize the scale's psychometric properties, with lower scores indicating a higher degree of self-perceived barriers. Main Outcomes and Measures: Diabetic retinopathy was graded from 2-field retinal images into categories of no DR (Early Treatment Diabetic Retinopathy Study levels 10-15; n = 154), mild to moderate DR (levels 20-43; n = 112), and severe DR (levels ≥53 and/or presence of clinically significant macular edema; n = 95) using the modified Airlie House classification system of DR. Multinomial logistic regression models were used to assess the association between perceived barriers and severity of DR in the worse-affected eye. Results: Among the 361 participants (105 women and 256 men; mean [SD] age, 57 [8] years), a greater magnitude of perceived barriers to DSM was independently associated with higher odds of having any DR (odds ratio, 1.32; 95% CI, 1.06-1.66), mild to moderate DR (odds ratio, 1.30; 95% CI, 1.01-1.68), and severe DR (odds ratio, 1.36; 95% CI, 1.03-1.79). This association was independent of diabetes control (hemoglobin A1c, blood pressure, and lipid levels), presenting visual acuity, and socioeconomic indicators. Conclusions and Relevance: These results suggest that greater perceived barriers to DSM are independently associated with severity of DR. Although longitudinal data are needed, these findings suggest that evidence-based interventions to reduce patient-, practitioner-, and system-related barriers to diabetes care may help reduce the risk of DR.

Association of serum lipid levels with retinal hard exudate area in African Americans with type 2 diabetes.

PURPOSE: Previous studies have yielded conflicting results regarding whether serum lipid levels are associated with retinal hard exudates in diabetic retinopathy. The majority of studies have assessed hard exudates only as a dichotomous trait (presence vs. absence) and included limited numbers of African Americans (AA). The purpose of this study was to determine if there are any associations between serum lipid levels and hard exudates in AA with type 2 diabetes (T2D). METHODS: 890 AA participants with T2D were enrolled from 5 sites. Macular fundus photographs were graded by masked ophthalmologist investigators. Hard exudate areas were measured using a semi-automated algorithm and ImageJ software. Multivariate regression models were used to determine the association between serum lipid levels and (1) presence of hard exudate and (2) area of hard exudate. RESULTS: Presence of hard exudates was associated with higher total cholesterol [(odds ratio (OR) = 1.08, 95 % confidence interval (CI) 1.03-1.13, P = 0.001)] and higher low-density lipoprotein (LDL) cholesterol (OR = 1.08, 95 % CI 1.03-1.14, P = 0.005) in models controlling for other risk factors. Hard exudate area was also associated with both higher total and LDL cholesterol levels (P = 0.04 and 0.01, respectively) in multivariate models controlling for other risk factors. CONCLUSIONS: Higher total and LDL cholesterol were associated with the presence of hard exudates and a greater hard exudate area in AA with T2D. This information can be used to counsel diabetic patients regarding the importance of lipid control to decrease the risk of macular hard exudates.

OPTICAL COHERENCE TOMOGRAPHY CHARACTERISTICS OF MACULAR EDEMA AND HARD EXUDATES AND THEIR ASSOCIATION WITH LIPID SERUM LEVELS IN TYPE 2 DIABETES.

PURPOSE: To determine whether hyperreflective foci (HF) and macular thickness on spectral domain ocular coherence tomography are associated with lipid levels in patients with Type 2 diabetes. METHODS: Two hundred and thirty-eight participants from four sites had fundus photographs and spectral domain ocular coherence tomography images graded for hard exudates and HF, respectively. Regression models were used to determine the association between serum lipid levels and 1) presence of HF and hard exudates and 2) central subfield macular thickness, central subfield macular volume, and total macular volume. RESULTS: All patients with hard exudates on fundus photographs had corresponding HF on spectral domain ocular coherence tomography, but 57% of patients with HF on optical coherence tomography did not have hard exudates detected in their fundus photographs. Presence of HF was associated with higher total cholesterol (odds ratio = 1.13, 95% confidence interval = 1.01-1.27, P = 0.03) and higher low-density lipoprotein levels (odds ratio = 1.17, 95% confidence interval = 1.02-1.35, P = 0.02) in models adjusting for other risk factors. The total macular volume was also associated with higher total cholesterol (P = 0.009) and triglyceride (P = 0.02) levels after adjusting for other risk factors. CONCLUSION: Higher total and low-density lipoprotein cholesterol were associated with presence of HF on spectral domain ocular coherence tomography. Total macular volume was associated with higher total cholesterol and triglyceride levels.

South Asian diabetic macular oedema treated with ranibizumab (ADMOR)-real-life experience.

PURPOSE Diabetic macular oedema (DMO) is a leading cause for visual impairment in the working age population in the UK. Ranibizumab has been shown to be effective in treatment of DMO in studies based on mainly Caucasian populations. This study reports the 12-month outcome in a cohort of South Asian subjects with DMO treated with ranibizumab.MethodsDMO in 51 eyes of 41 South Asian patients was treated with ranibizumab 0.5 mg according to the modified DRCRnet protocol I. Visual acuity (VA) and central macular thickness (CMT) were recorded at baseline, 3, 6, and 12 months. Results were compared for eyes with different baseline visual acuities and different baseline macular thicknesses.RESULTS Over the 12-month period, the mean ETDRS VA increased from 55.3±13.4 letters to 63.8±15.2 letters for all eyes. At 12 months, 70.6% eyes gained 5 or more letters acuity and 17.6% eyes gained 15 letters or more. During the same period, the mean CMT decreased from 532±129 to 318±136 µm. Eyes that had received previous laser treatments had a mean letter gain of 9.2 letters, compared with 8.5 for all eyes at 12 months.CONCLUSIONS Ranibizumab 0.5 mg is safe and effective at reversing vision loss due to DMO in patients of South Asian origin at 12 months. Ranibizumab treatment appears to be effective in patients with longstanding DMO who received prior laser treatments. Further studies are needed to define the long-term outcome in patients of different ethnicity and DMO.

Macular edema in Asian Indian premature infants with retinopathy of prematurity: Impact on visual acuity and refractive status after 1-year.

PURPOSE: To report the impact of transient, self-resolving, untreated "macular edema" detected on spectral domain optical coherence tomography in Asian Indian premature infants with retinopathy of prematurity (ROP) on visual acuity (VA) and refraction at 1-year of corrected age. MATERIALS AND METHODS: Visual acuity and refraction of 11 infants with bilateral macular edema (Group A) was compared with gestational age-matched 16 infants with ROP without edema (Group B) and 17 preterms infants without ROP and without edema (Group C) at 3, 6, 9 and 12 months of corrected age using Teller Acuity Cards and cycloplegic retinoscopy. Sub-group analysis of the previously described pattern A and B macular edema was performed. RESULTS: Visual acuity was lower in infants with macular edema compared with the other two control groups throughout the study period, but statistically significant only at 3 months. Visual improvement in these infants was highest between the 3 rd and 6 th month and plateaued by the end of the 1 st year with acuity comparable to the other two groups. The edema cohort was more hyperopic compared to the other two groups between 3 and 12 months of age. Pattern A edema had worse VA compared to pattern B, although not statistically significant. CONCLUSION: Macular edema, although transient, caused reduced VA as early as 3 months of corrected age in Asian Indian premature infants weighing <2000 g at birth. The higher hyperopia in these infants is possibly due to visual disturbances caused at a critical time of fovealization. We hypothesize a recovery and feedback mechanism based on the principles of active emmetropization to explain our findings.

The REVEAL Study: Ranibizumab Monotherapy or Combined with Laser versus Laser Monotherapy in Asian Patients with Diabetic Macular Edema.

OBJECTIVE: The primary study hypothesis was that ranibizumab 0.5 mg monotherapy or combined with laser is superior to laser monotherapy based on mean average change in best-corrected visual acuity (BCVA) over 12 months in Asian patients with visual impairment resulting from diabetic macular edema (DME). DESIGN: A 12-month, randomized, double-masked, multicenter, laser-controlled, phase III study. PARTICIPANTS: Three hundred ninety-six patients aged ≥18 years, with type 1 or 2 diabetes mellitus, BCVA of 78-39 Early Treatment Diabetic Retinopathy Study (ETDRS) letters, and visual impairment resulting from DME. METHODS: Patients were randomized to ranibizumab + sham laser (n = 133), ranibizumab + active laser (n = 132), or sham injection + active laser (n = 131). Ranibizumab/sham injections were administered on day 1 and continued monthly. As of month 3, monthly injections were continued if stable vision was not reached. Treatment was reinitiated if BCVA decreased because of DME progression. Active/sham laser was administered on day 1 and thereafter according to ETDRS guidelines. MAIN OUTCOME MEASURES: Average change in BCVA from baseline to months 1 through 12, central retinal subfield thickness (CRST), and safety over 12 months. RESULTS: Ranibizumab monotherapy or combined with laser was superior to laser in improving mean average change in BCVA from baseline to months 1 through 12 (+5.9 and +5.7 vs +1.4 letters). At month 12, greater proportion of patients gained ≥15 letters with ranibizumab and ranibizumab + laser compared with laser (18.8% and 17.8% vs 7.8%). Mean CRST reduced significantly from baseline to month 12 with ranibizumab (-134.6 µm) and ranibizumab + laser (-171.8 µm) versus laser (-57.2 µm). Patients received a mean of 7.8 and 7.0 ranibizumab injections in the ranibizumab and ranibizumab + laser arms, respectively, and 1.5-1.9 active laser across treatment arms over 12 months. Conjunctival hemorrhage was the most common ocular, whereas nasopharyngitis and hypertension were the most common nonocular adverse events. Ranibizumab was not associated with any cases of cerebrovascular hemorrhage and cerebrovascular ischemia. No death related to study treatment was reported. CONCLUSIONS: Ranibizumab monotherapy or combined with laser showed superior BCVA improvements over laser treatment alone in Asian patients with visual impairment resulting from DME. No new ocular or nonocular safety findings were observed and treatment was well tolerated over 12 months.

Visual Impairment and Blindness Avoided with Ranibizumab in Hispanic and Non-Hispanic Whites with Diabetic Macular Edema in the United States.

OBJECTIVE: To estimate visual impairment (VI) and blindness avoided with intravitreal ranibizumab 0.3 mg treatment for central-involved diabetic macular edema (DME) among Hispanic and non-Hispanic white individuals in the United States. DESIGN: Population-based model simulating visual acuity (VA) outcomes over 2 years after diagnosis and treatment of DME. PARTICIPANTS: Visual acuity changes with and without ranibizumab were based on data from the RISE, RIDE, and DRCR Network trials. METHODS: For the better-seeing eye, VA outcomes included VI, defined as worse than 20/40 in the better-seeing eye, and blindness, defined as VA of 20/200 or worse in the better-seeing eye. Incidence of 1 or both eyes with central-involved DME in 2010 were estimated based on the 2010 United States population, prevalence of diabetes mellitus, and 1-year central-involved DME incidence rate. Sixty-one percent of incident individuals had bilateral DME and 39% had unilateral DME, but DME could develop in the fellow eye. MAIN OUTCOMES MEASURES: Cases of VI and blindness avoided with ranibizumab treatment. RESULTS: Among approximately 102 million Hispanic and non-Hispanic white individuals in the United States 45 years of age and older in 2010, an estimated 37 274 had central-involved DME and VI eligible for ranibizumab treatment. Compared with no ranibizumab treatment, the model predicted that ranibizumab 0.3 mg every 4 weeks would reduce the number of individuals with VI from 11 438 (95% simulation interval [SI], 7249-16 077) to 6304 (95% SI, 3921-8981), a 45% (95% SI, 36%-53%) reduction at 2 years. Ranibizumab would reduce the number of incident eyes with VA worse than 20/40 from 16 910 (95% SI, 10 729-23 577) to 9361 (95% SI, 5839-13 245), a 45% (95% SI, 38%-51%) reduction. Ranibizumab was estimated to reduce the number of individuals with legal blindness by 75% (95% SI, 58%-88%) and the number of incident eyes with VA of 20/200 or worse by 76% (95% SI, 63%-87%). CONCLUSIONS: This model suggests that ranibizumab 0.3 mg every 4 weeks substantially reduces prevalence of VI and legal blindness 2 years after initiating treatment among Hispanic and non-Hispanic white individuals in the United States with central-involved DME that has caused vision loss.

Spectral-domain optical coherence tomography imaging of retinal changes after conventional multicolor laser, subthreshold micropulse diode laser, or pattern scanning laser therapy in Japanese with macular edema.

PURPOSE: To perform optical coherence tomography imaging of retinal healing after conventional multicolor laser, pattern scanning laser, or micropulse laser treatment and compare the characteristics of each method. METHODS: This was a single-center interventional case series study. Twenty-nine patients with macular edema underwent laser photocoagulation. Changes of retinal morphology because of laser-tissue interaction were assessed within 3 months by using a spectral-domain optical coherence tomography. RESULTS: Immediately after conventional multicolor laser or pattern scanning laser treatment, a hyperreflective band appeared at the laser sites. The photoreceptor inner segment-outer segment line disappeared in all the patients treated with a conventional multicolor laser, but was intact in 22.2% (2/9 eyes) after pattern scanning laser. From 1 week to 1 month, the bands resolved. At 3 months, recovery of the inner segment-outer segment line surrounding the laser site was seen in all patients after conventional grid photocoagulation and pattern scanning laser. Retinal morphology did not change at any time during the observation period after subthreshold micropulse diode laser photocoagulation. CONCLUSION: The characteristic in vivo effects of retinal photocoagulation were monitored over time by spectral-domain optical coherence tomography. Changes of retinal morphology appeared less intense after pattern scanning laser than conventional grid laser treatment.

Four-year incidence and progression of diabetic retinopathy and macular edema: the Los Angeles Latino Eye Study.

PURPOSE: To estimate the 4-year incidence and progression of diabetic retinopathy, macular edema (ME) and clinically significant macular edema (CSME) among adult Latinos with diabetes mellitus. DESIGN: A population-based, longitudinal study of 4658 self-identified Latinos (primarily Mexican Americans), residing in Los Angeles, examined at baseline (2000-2003) and at 4 years (2004-2008). METHODS: Participants underwent a standardized ophthalmic examination. Diabetic retinopathy (DR) and CSME were detected by grading of stereoscopic fundus photographs using the modified Airlie House classification scheme. chi(2) and trend tests were used to assess differences in incidence when stratifying by age and duration of diabetes. RESULTS: The 4-year incidence of DR, ME, and CSME was 34.0% (182/535), 5.4% (38/699), and 7.2% (50/699) respectively. Younger persons and those with longer duration of diabetes mellitus had a higher incidence of DR compared to those who were older and had shorter duration of diabetes mellitus. A higher incidence of ME was associated with longer duration of diabetes mellitus (P = .004). Worsening/progression of any DR was found in 38.9% (126/324) and improvement occurred in 14.0% (37/265) of participants. Progression from nonproliferative DR (NPDR) to proliferative DR (PDR) and from NPDR to PDR with high-risk characteristics occurred in 5.3% and 1.9% of participants. CONCLUSIONS: The 4-year incidence and progression of DR and the incidence of ME and CSME among Latinos are high compared to non-Hispanic whites. These findings support the need to identify and modify risk factors associated with these long-term complications.

Subthreshold micropulse diode laser photocoagulation for diabetic macular edema in Japanese patients.

PURPOSE: To assess the efficacy and safety of subthreshold micropulse diode laser photocoagulation for diabetic macular edema (ME). DESIGN: Prospective, nonrandomized interventional case series. SETTING: Institutional. PATIENTS: Thirty-six consecutive diabetic patients (43 eyes) with clinically significant ME and a central macular thickness (CMT) <600 microm by optical coherence tomography. OBSERVATION PROCEDURES: Subthreshold micropulse diode laser photocoagulation was done with a 15% duty cycle (0.2 to 0.3 sec; 200 microm) at 50% to 90% of the burn threshold energy. The treated area was monitored on color images for 12 months. MAIN OUTCOME MEASURES: CMT, best-corrected visual acuity (BCVA), and total macular volume at 3 months. RESULTS: After 3 months, there was a significant reduction of CMT (P = .05, paired t test), but the changes of BCVA and macular volume were not significant. The preoperative CMT, BCVA (logarithm of the minimal angle of resolution; logMAR), and macular volume were 341.8 +/- 119.0 microm, 0.12 +/- 0.20, and 8.763 +/- 1.605 mm(3) respectively, vs 300.7 +/- 124.1 microm, 0.12 +/- 0.21, and 8.636 +/- 1.408 mm(3) at 3 months. CMT decreased significantly from 1 month (P = .015, Friedman test). Visual acuity was improved or maintained within 0.2 logMAR for 12 months in 94.7% of the patients. No obvious laser scars were detected in any patient. CONCLUSIONS: In patients with moderate diabetic ME, subthreshold micropulse diode laser photocoagulation controls ME and maintains visual acuity with minimal retinal damage. These findings confirm the efficacy of this method for Japanese patients.

Ethnicity, race, and clinically significant macular edema in the Veterans Affairs Diabetes Trial (VADT).

OBJECTIVE: To determine risk factors in clinically significant macular edema (CSME) and if increased CSME in minorities is due to ethnicity or other factors in the Veterans Affairs Diabetes Trial (VADT). METHODS: CSME prevalence based on 7-field stereo fundus photographs in 1268 patients with type 2 diabetes was related to ethnicity, demographics and biochemistries by univariate and multivariate analyses. RESULTS: Hispanics (H) made up 17.5% and African Americans (AA) 17.7% of the cohort. CSME prevalence was 10%. In univariate analysis, CSME was more prevalent in H, 18%, and AA, 15.6% than in non-Hispanic Whites (NHW), 6.3%, p<0.01. Univariate regression of CSME associated with younger age, younger onset of diabetes; longer duration; retinopathy severity; and high HbA1c, BP, urine albumin/creatinine, and amputation, all p<0.01. In multivariate regression, CSME was associated with ethnicity/race (Hispanic White vs. non-Hispanic White, OR, (95% CI), 2.30, (1.35-3.92), p<0.01; African American vs. non-Hispanic White, 2.30, (1.33-4.00), p<0.01), diastolic BP (1.13 per 5 mm Hg, (1.02-1.23), p=0.03), amputation (3.0, (1.11-8.13), p=0.04), and retinopathy severity ( approximately 30, ( approximately 17 to approximately 59), p<0.01). CONCLUSION: The prevalence of CSME in the VADT is associated with ethnicity as well as diastolic BP, amputation, and retinopathy severity.

Comparison of diabetic retinopathy phenotype between Latinos and Blacks.

OBJECTIVE: The objective of this study was to delineate the difference in the phenotype of diabetic retinopathy (DR) in Latinos versus Blacks using characteristics shown on fundus photography (FP) and fluorescein angiography (FA). RESEARCH DESIGN AND METHODS: This was a retrospective chart review of 203 adult Black and Latino diabetic patients from the King-Drew Medical Center eye clinic from January 1998 to March 2005. Systemic risk factors such as HbA(1c) and kidney function data were collected. FP and FA were analyzed and graded according to Early Treatment of Diabetic Retinopathy Study criteria. Statistical analysis was performed to determine whether a given lesion type was more characteristic of a particular racial group. RESULTS: Gender, age, median microalbumin-to-creatinine ratio (ACR), and average HbA(1c) values were not significantly different between the groups. The presence of clinically significant macular edema (CSME), focal or diffuse, was very high in both groups (44% in Latinos and 46% in Blacks), and the overall DR grades were similar. However, upon individual lesion analysis, the Latinos were noted to have more prevalent intraretinal hemorrhages involving a greater area of the retina (P=.046). CONCLUSIONS: Although Latinos and Blacks of comparable age and glycemic control are equally at risk for CSME and proliferative retinopathy, Latinos may be at greater risk for a specific phenotype of DR characterized by extravasation of intraretinal hemorrhages, which is associated with poor prognosis. Further prospective studies may uncover racial differences that may have implications for prognosis and therapy.

A randomized trial comparing intravitreal triamcinolone and focal/grid photocoagulation for diabetic macular edema: baseline features.

PURPOSE: To compare baseline demographic, systemic, and ocular characteristics within age and racial subgroups among participants in this Diabetic Retinopathy Clinical Research Network clinical trial and to compare this cohort with other cohorts enrolled in phase 3 clinical trials for diabetic retinopathy. METHODS: Thirty-six month, randomized, controlled, multicenter clinical trial of 693 participants with diabetic macular edema enrolled at 88 clinical sites in the United States. Participants were categorized into self-reported race/ethnicity subgroups and into one of three age groups: 18 to <60, 60 to <70, and 70 and older. RESULTS: Mean age of participants was 63 years, 72% were white, and median visual acuity letter score was 62 (approximately 20/63). No substantial difference was identified between racial subgroups for any baseline variable. Older participants were more likely to have Type 2 diabetes mellitus and longer duration disease. The most frequent levels of diabetic retinopathy among 840 study eyes were moderate (level 43) to moderately severe (level 47) nonproliferative disease. CONCLUSION: While the racial composition of this cohort does not differ from other cohorts in large phase 3 trials that have evaluated participants with diabetic retinopathy, the inclusion of many subjects over age 70 and a better level of glycemic control are distinguishing features.

Six-year progression of retinopathy and associated risk factors in African American patients with type 1 diabetes mellitus: the New Jersey 725.

OBJECTIVE: To report the 6-year progression of diabetic retinopathy (DR) and associated risk factors among African American patients with type 1 (insulin-dependent) diabetes mellitus. METHODS: Participants from the New Jersey 725 included 483 African American patients with type 1 diabetes who underwent reexamination as part of a 6-year follow-up. Evaluations included a structured clinical interview, ocular examination, 7 stereoscopic fundus photographs, and blood pressure measurements. Severity of DR was determined via masked grading of fundus photographs. Biological evaluation included blood and urine assays. RESULTS: During the 6-year period, 56.1% of patients at risk showed progression of DR; 15.0% showed progression to proliferative DR; and 15.9% developed macular edema. A baseline high glycosylated hemoglobin level and systemic hypertension were significant risk factors for progression of DR, progression to proliferative DR, and incidence of macular edema. Progression to proliferative DR was significantly associated with baseline older age, renal disease, and severity of DR. The incidence of macular edema was significantly associated with baseline older age, low socioeconomic status, severity of DR, and total serum cholesterol level. CONCLUSIONS: Six-year progression of DR is high in African American patients with type 1 diabetes. Improving glycemic and blood pressure control may reduce the ocular morbidity of diabetes in African Americans.