Cost-effectiveness of Anti-VEGF treatments for age-related macular degeneration: a Brazilian perspective.

PURPOSE: To study the cost-effectiveness of ranibizumab and bevacizumab for the treatment of age-related macular degeneration. METHODS: We used a decision tree model to analyze the cost-effectiveness of ranibizumab and bevacizumab for the treatment of age-related macular degeneration, from the Brazilian Public Health System (SUS) perspective. Ranibizumab and bevacizumab were administered to patients with the same treatment procedure, and the difference in treatment costs was calculated based on the cost of the drugs. Direct costs were estimated using the information provided by the Brazilian SUS. Effectiveness in terms of quality-adjusted life years (QALYs) was calculated based on the utility values for visual impairment. Incremental cost-effectiveness ratio was calculated by comparing both treatments. The analytical horizon was one year. RESULTS: The decision tree analysis showed that the difference in treatment effectiveness was 0.01 QALY. Incremental cost-effectiveness ratio showed that ranibizumab treatment required an incremental annual cost of more than R$ 2 million to generate 1 additional QALY, as compared to bevacizumab. CONCLUSIONS: From the Brazilian SUS perspective, bevacizumab is more cost-effective than ranibizumab for the treatment of neovascular age-related macular degeneration. Its use could allow potential annual savings in health budget.

Cost-effectiveness of Anti-VEGF treatments for age-related macular degeneration: a Brazilian perspective / Estudo de custo-efetividade de tratamentos para a degeneração macular relacionada à idade: uma perspectiva brasileira

ABSTRACT Purpose: To study the cost-effectiveness of ranibizumab and bevacizumab for the treatment of age-related macular degeneration. Methods: We used a decision tree model to analyze the cost-effectiveness of ranibizumab and bevacizumab for the treatment of age-related macular degeneration, from the Brazilian Public Health System (SUS) perspective. Ranibizumab and bevacizumab were administered to patients with the same treatment procedure, and the difference in treatment costs was calculated based on the cost of the drugs. Direct costs were estimated using the information provided by the Brazilian SUS. Effectiveness in terms of quality-adjusted life years (QALYs) was calculated based on the utility values for visual impairment. Incremental cost-effectiveness ratio was calculated by comparing both treatments. The analytical horizon was one year. Results: The decision tree analysis showed that the difference in treatment effectiveness was 0.01 QALY. Incremental cost-effectiveness ratio showed that ranibizumab treatment required an incremental annual cost of more than R$ 2 million to generate 1 additional QALY, as compared to bevacizumab. Conclusions: From the Brazilian SUS perspective, bevacizumab is more cost-effective than ranibizumab for the treatment of neovascular age-related macular degeneration. Its use could allow potential annual savings in health budget.

RESUMO Objetivo: Estudar o custo-efetividade do ranibizumabe e bevacizumabe no tratamento da degeneração macular relacionada à idade neovascular. Métodos: Utilizamos um modelo de árvore de decisão para analisar a relação custo-efetividade do ranibizumabe e bevacizumabe no tratamento da degeneração macular relacionada à idade, sob a perspectiva do Sistema Único de Saúde. O ranibizumabe e bevacizumabe foram administrados a pacientes com o mesmo procedimento de tratamento, e a diferença nos custos do tratamernto foi calculada com base no custo dos medicamentos. Os custos diretos foram estimados utilizando as informações fornecidas pelo SUS. A efetividade foi determinada em anos de vida ajustados pela qualidade (QALY) baseados em valores de utilidade em deficiênciavisual. A razãoincremental custo-efetividadefoicalculada comparando os dois tratamentos. O horizonte analítico foi de um ano. Resultados: A análise da árvore de decisão mostrou que a diferença na efetividade do tratamento foi de 0,01 QALY. A razão incremental de custo-efetividade mostrou que o tratamento com ranibizumabe exigiu um custo anual incremental de R$ 2 milhões para gerar um QALY adicional, em comparação ao bevacizumabe. Conclusões: Do ponto de vista do SUS, o bevacizumabe é mais custo-efetivo que o ranibizumabe no tratamento da degeneração macular relacionada à idade neovascular. O seu uso poderia gerar uma grande economia anual para o orçamento em saúde.

Effectiveness of monthly and fortnightly anti-VEGF treatments for age-related macular degeneration / Efetividade de tratamentos anti-VEGF mensais e quinzenais para a degeneração macular relacionada à idade

ABSTRACT Purpose: To study the efficacy and safety of treatments with ranibizumab and bevacizumab for exudative age-related macular degeneration. Methods: A parallel randomized clinical trial was conducted to compare the efficacy and safety of three regimens (bevacizumab every month, bevacizumab every 2 weeks, and ranibizumab every month), followed by as-needed retreatments, for 1 year, in previously untreated individuals with age-related macular degeneration. The primary outcome was change in visual acuity and in central macular thickness after 1 year of follow-up. Subjects were assigned randomly to one of the three groups in a 1:1:1 ratio, and investigators and examiners were blinded to the randomization results. Results: We included 15 patients in each group. After 1 year of follow-up, we found statistically significant improvements in visual acuity and central macular thickness reduction in all groups. However, we found no statistically significant differences between the three groups. Conclusions: The bi-weekly follow-up was effective and we found no significant differences in efficacy or safety between the treatments with ranibizumab and bevacizumab.

RESUMO Objetivo: Estudar a eficácia e segurança dos tratamentos com ranibizumabe e bevacizumabe para a degeneração macular relacionada à idade exsudativa. Métodos: Ensaio clínico paralelo randomizado foi conduzido para comparar a eficácia e segurança de três regimes (bevacizumabe a cada mês, bevacizumabe a cada 2 semanas e ranibizumabe todos os meses), seguidos por retratamentos conforme necessidade, durante 1 ano, em indivíduos previamente não tratados com degeneração macular relacionada à idade. O desfecho primário foi alteração na acuidade visual e na espessura macular central após um ano de seguimento. Os indivíduos foram designados aleatoriamente para um dos 3 grupos em uma proporção de 1:1:1, e os investigadores e examinadores foram mascarados para os resultados da randomização. Resultados: Foram incluídos 15 pacientes em cada grupo. Após um ano de seguimento, encontramos melhorias estatisticamente significativas na acuidade visual e na redução da espessura macular central em todos os grupos. No entanto, não encontramos diferenças estatisticamente significativas entre os 3 grupos. Conclusões: O seguimento quinzenal foi eficaz e não encontramos diferenças significativas na eficácia ou segurança entre os tratamentos com bevacizumabe e ranibizumabe.

Effectiveness of monthly and fortnightly anti-VEGF treatments for age-related macular degeneration.

PURPOSE: To study the efficacy and safety of treatments with ranibizumab and bevacizumab for exudative age-related macular degeneration. METHODS: A parallel randomized clinical trial was conducted to compare the efficacy and safety of three regimens (bevacizumab every month, bevacizumab every 2 weeks, and ranibizumab every month), followed by as-needed retreatments, for 1 year, in previously untreated individuals with age-related macular degeneration. The primary outcome was change in visual acuity and in central macular thickness after 1 year of follow-up. Subjects were assigned randomly to one of the three groups in a 1:1:1 ratio, and investigators and examiners were blinded to the randomization results. RESULTS: We included 15 patients in each group. After 1 year of follow-up, we found statistically significant improvements in visual acuity and central macular thickness reduction in all groups. However, we found no statistically significant differences between the three groups. CONCLUSIONS: The bi-weekly follow-up was effective and we found no significant differences in efficacy or safety between the treatments with ranibizumab and bevacizumab.

New Drugs and New Posterior Delivery Methods in CME.

PURPOSE: To discuss the characteristics, indications and adverse events (AEs) of sustained-release corticosteroid devices for the treatment of cystoid macular edema (CME). RECENT FINDINGS: Ozurdex® is approved for the treatment of diabetic macular edema (DME), retinal vein occlusion related-CME and noninfectious posterior uveitis (NIPU). It releases dexamethasone over a maximum period of 6 months making repeated intravitreal injections necessary for recurrent CME. Iluvien® releases fluocinolone for up to 36 months and is effective for the treatment of chronic DME. Retisert® (Bausch & Lomb, Rochester, NY) also releases fluocinolone, and is approved for chronic NIPU. Both Iluvien® and Retisert® are non-biodegradable devices and are highly associated with cataract and glaucoma. SUMMARY: Long-acting intraocular corticosteroid formulations offer a more predictable drug-release profile and reduced dosing frequency in comparison to conventional formulations of the same compounds but the risk-benefit ratio must be taken into consideration previous to the implantation of those devices.

Choroidal Thickness in Eyes With Central Geographic Atrophy Secondary to Stargardt Disease and Age-Related Macular Degeneration.

BACKGROUND AND OBJECTIVE: Choroidal thickness (CT) measurements from eyes with similar areas of macular geographic atrophy (GA) secondary to age-related macular degeneration (AMD) and Stargardt disease (STGD) were compared to determine whether GA from different diseases had a similar or different effect on the underlying subfoveal choroid. PATIENTS AND METHODS: Eyes with the diagnosis of central GA secondary to STGD and AMD were matched, with subfoveal CT measurements obtained from the central B-scan using an enhanced depth imaging protocol. The area of GA was measured using fundus autofluorescence (FAF) imaging. AMD eyes were divided into those with and without reticular pseudodrusen. RESULTS: A total of 22 eyes of 22 patients were included in the STGD and AMD groups and were matched with respect to the area of GA. The mean age of the STGD patients was 48.9 years (standard deviation [SD]=17.1), and the mean age was 81.8 years (SD=6.2) for the AMD patients. Mean area measurements of GA for the STGD and AMD groups were 5.4 mm2 (SD=4.1) and 5.1 mm2 (SD=4.0), respectively (P=.83). After adjusting for age and axial length, eyes with STGD had a mean CT measurement greater than the AMD eyes (336.1 µm vs. 198.1 µm, respectively; P=.039). However, this difference was driven by AMD eyes with reticular pseudodrusen (RPD) and by a single Stargardt case with a very thick choroid. Eyes with RPD had statistically thinner subfoveal CT measurements when compared with all other groups. CONCLUSION: A small but statistically significant increase in the CT of STGD eyes was observed when compared with normal controls and AMD eyes without RPD. However, this small increase in CT was driven by a single case with a markedly thicker choroid within the STGD group, so it is unlikely that a clinically significant difference exists. However, AMD eyes with GA and RPD had significantly thinner subfoveal CT measurements.

Association Between Growth of Geographic Atrophy and the Complement Factor I Locus.

The association between the growth of geographic atrophy (GA) and a single nucleotide polymorphism (SNP) in the complement factor I (CFI) locus was investigated in the COMPLETE trial. Growth of GA at 52 weeks in eyes without the CFI at-risk allele was slightly faster than the growth in eyes with the CFI at-risk allele (P ≥ .72). The authors of the current study found that in contrast to the faster growth rate reported in CFI-positive eyes from the MAHALO trial, the CFI positive eyes in the COMPLETE trial did not grow faster, and this analysis included 24 eyes that met the MAHALO eligibility criteria.

Association Between Subfoveal Choroidal Thickness, Reticular Pseudodrusen, and Geographic Atrophy in Age-Related Macular Degeneration.

BACKGROUND AND OBJECTIVE: To compare subfoveal choroidal thickness (CT) measurements in eyes with nonexudative age-related macular degeneration (AMD) in the presence or absence of reticular pseudodrusen (RPD). PATIENTS AND METHODS: Subfoveal CT measurements obtained from patients with AMD enrolled in the COMPLETE study (30 drusen-only eyes and 30 eyes with geographic atrophy [GA]) were compared with an age-distributed normal control group. Multimodal images were evaluated to detect the presence of RPD. RESULTS: After controlling for age and axial length, the mean CT was significantly thinner in the GA group with RPD (213.7 ± 53.1 µm) than in the GA group without RPD (335.3 ± 123.2 µm; P = .001). The mean CT in the GA group without RPD was not statistically different from the mean CT in the normal control group (P = .076) or the drusen group without RPD (P = .45). In eyes without RPD, there was a correlation between the increasing size of GA and a decrease in CT measurements. CONCLUSION: Subfoveal choroidal thinning in eyes with nonexudative AMD was associated with the presence of RPD. In the absence of RPD, CT only decreased as the size of GA increased.

Comparison of Geographic Atrophy Growth Rates Using Different Imaging Modalities in the COMPLETE Study.

BACKGROUND AND OBJECTIVE: To compare the measurements and growth rates of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) obtained using different imaging modalities. PATIENTS AND METHODS: Thirty patients with AMD and GA measuring from 1.25 mm² to 18 mm² based on spectral-domain optical coherence tomography (SD-OCT) fundus imaging were enrolled. Imaging was performed at baseline and at follow-up months 3, 6, 9, and 12, including autofluorescence (AF) imaging with a fundus camera-based flash system (TRC-50DX; Topcon Medical Systems, Oakland, NJ; AF excitation λ: 535-585 nm; detection λ: 605-715 nm), AF and fluorescein angiography (FA) imaging with a confocal scanning laser ophthalmoscopy (SLO) system (Spectralis; Heidelberg Engineering, Heidelberg, Germany; AF excitation λ: 488 nm; detection λ: > 500 nm), and SD-OCT en face imaging (Cirrus; Carl Zeiss Meditec, Dublin, CA). RESULTS: Average baseline square root measurements and enlargement rates of square root areas appeared similar across all modalities; 0.2 mm was the largest difference between any pair of measurement means. The intraclass correlation coefficients (ICC) were essentially equal to 1 for all comparisons of area measurements but were lower for growth rates than area measurements. Comparison of 26-week average enlargement rates showed no significant difference between the SLO AF image and enhanced SD-OCT en face image (mean difference: 0.01 mm; SD: 0.10; P = .70). CONCLUSION: Agreement among all imaging modalities in measuring the areas of GA at baseline diminished when the growth rates of GA were compared over 26 weeks, likely because each imaging technique identifies different anatomic features along the border of GA, which may appear similar but change at different rates.

Spectral-domain optical coherence tomography measurements of choroidal thickness and outer retinal disruption in macular telangiectasia type 2.

BACKGROUND AND OBJECTIVE: To evaluate subfoveal choroidal thickness (CT) and the extent of outer retinal disruption in patients with macular telangiectasia type 2 (MacTel2) compared with healthy eyes. PATIENTS AND METHODS: In this prospective, observational, cohort study, 62 patients (62 eyes) with Mac-Tel2 and 130 healthy controls (130 eyes) underwent a complete ophthalmological examination, spectral-domain optical coherence tomography (SD-OCT) imaging, and axial length measurements. Patients in the study group also underwent color fundus photography, fundus autofluorescence, and fluorescein angiography. En face SD-OCT imaging was used to assess abnormalities involving the photoreceptor inner segment/outer segment/ellipsoid zone (IS/OS/EZ). RESULTS: After adjusting for age and axial length, the authors found that eyes with MacTel2 had a mean CT measurement that was greater than control eyes (P = .007). There was a negative correlation between the visual acuity and the area of IS/OS/EZ damage (P = .009), but no statistically significant correlation was seen between CT and the area of IS/OS/EZ damage. CONCLUSION: Eyes with MacTel2 were found to have thicker CT measurements than control eyes. While the extent of IS/OS/EZ disruption correlated with the loss of visual acuity, this damage did not correlate with CT measurements.

Dye solutions based on lutein and zeaxanthin: in vitro and in vivo analysis of ocular toxicity profiles.

PURPOSE: To study the safety profile of Lutein/Zeaxanthin(L/Z)-based natural dye solutions in in vitro and in vivo models. MATERIAL AND METHODS: In vitro cytotoxicity and cellular growth experiments were carried out on ARPE-19 and human corneal epithelial (HCE) cell lines using different L/Z-based dye solutions, either alone or in association with brilliant blue (BB) or trypan blue (TB). Light and transmission electron microscopy studies were performed seven days after intravitreal injection of dye solutions in rabbits. Electroretinogram (ERG) recordings were taken at baseline and before histopathology. RESULTS: In vitro cytotoxicity assays demonstrated that the different L/Z-based solutions (from 0.3 to 2%), either alone or in association with BB (0.025%) or TB (0.04%), did not significantly alter mitochondrial activity (≤15%) in the cell lines tested. In addition, in vitro cell growth was inhibited by up to 60% depending on the dye solution, and in direct proportion to the concentration assayed. There was no evidence of structural alterations in the neurosensory retina, retinal pigment epithelium (RPE), or choriocapillaris-choroidal complex. b-Wave ERG records showed no significant differences (±15.2%) in comparison with baseline. CONCLUSIONS: L/Z-based dye solutions demonstrated a safe profile in in vitro and in vivo models, and may be a useful tool for staining intraocular structures.

Response to aflibercept after frequent re-treatment with bevacizumab or ranibizumab in eyes with neovascular AMD.

BACKGROUND AND OBJECTIVE: To evaluate the effects of switching to aflibercept in eyes with neovascular age-related macular degeneration (AMD) requiring frequent re-treatment with bevacizumab or ranibizumab. PATIENTS AND METHODS: Retrospective review of 73 eyes of 65 patients with neovascular AMD switched to aflibercept due to persistent or recurrent macular fluid after at least 1 year of intravitreal bevacizumab or ranibizumab with re-treatment at least every 6 weeks. Minimum post-switch follow-up was 6 months. All patients were treated using a treat-and-extend strategy. The treatment intervals immediately after and before the switch were the same. RESULTS: The mean pre-switch anti-VEGF therapy duration was 45 months, and the mean number of injections was 31. In the 6 months after the switch, the average number of injections was reduced by 0.6 compared with the 6 months before the switch (P < .001). Visual acuity was unchanged during this period (P = .78). Central retinal thickness (CRT) decreased by 19 µm after the switch (P < .001). Seventy eyes had vascularized retinal pigment epithelial detachments (PEDs). The decrease in the PED cube-root volume during the 6 months after the switch was statistically significant (-0.07 mm; P = .007). CONCLUSION: The number of injections, CRT, and PED volume decreased significantly after the switch to aflibercept, but visual acuity was unchanged.

Safety and efficacy of various concentrations of topical lidocaine gel for intravitreal injection.

INTRODUCTION: Intravitreal injection (IVT) is one of the most common vitreoretinal procedures, a large majority are performed with local anesthesia. The purpose of this study was to investigate the safety to the cornea and anesthetic efficacy of five concentrations of lidocaine gel. METHODS: A prospective clinical trial was conducted testing lidocaine gel in five preparations: 2, 3.5, 5, 8 and 12%. Patients with macular degeneration, diabetic edema or retina vein occlusion were scheduled for intravitreal treatment received topical anesthesia with lidocaine gel 5 and 10 min before the procedure. Patients answered the visual analog scale for pain during the procedure. Corneal and conjunctival was evaluated using the Oxford scale. RESULTS: In total, 260 patients were randomized into five groups. The mean pain scores (± standard deviation) were 2.63 (± 1.68) in the 2% group, 2.08 (± 1.35) in the 3.5%; 2.00 (± 1.65) in the 5%, 1.93 (± 1.40) in the 8% and 1.83 (± 1.35) in the 12% group. Mean pain score among all groups was similar (p = 0.077). There was no significant difference between groups in regard to keratitis mean score (p = 0.897). CONCLUSIONS: Lidocaine gel at concentrations from 2 to 12% induced similar anesthetic effect for IVTs, without adverse effects on cornea and conjunctiva.

Change in drusen volume as a novel clinical trial endpoint for the study of complement inhibition in age-related macular degeneration.

BACKGROUND AND OBJECTIVE: To evaluate the change in drusen volume following treatment with eculizumab, a systemic inhibitor of complement component 5. PATIENTS AND METHODS: Single-center, prospective, randomized, double-masked clinical trial. Patients were randomized 2:1 to receive intravenous eculizumab or placebo over 26 weeks. MAIN OUTCOME MEASURE: decrease in drusen volume of at least 50% at 26-week follow-up. RESULTS: Mean drusen cube root volumes were 0.49 mm and 0.47 mm (P = .64) at baseline and 0.51 mm and 0.42 mm (P = .17) at 26 weeks in the eculizumab and placebo groups, respectively. In the placebo group, one eye had a decrease in drusen volume of at least 50% and two eyes developed neovascularization through 26 weeks. CONCLUSION: Systemic complement inhibition with eculizumab did not significantly reduce drusen volume. Drusen growth was dependent on the number of complement at-risk alleles. Future trials should consider the use of a composite clinical trial endpoint in which efficacy is defined by the treatment's ability to prevent drusen growth, neovascularization, and the formation of geographic atrophy over 1 year.

Systemic complement inhibition with eculizumab for geographic atrophy in age-related macular degeneration: the COMPLETE study.

PURPOSE: To evaluate the effect of eculizumab, a systemic inhibitor of complement component (C5), on the growth of geographic atrophy (GA) in patients with age-related macular degeneration (AMD). DESIGN: Prospective, double-masked, randomized clinical trial. PARTICIPANTS: Patients with GA measuring from 1.25 to 18 mm(2) based on spectral-domain optical coherence tomography imaging. METHODS: Patients were randomized 2:1 to receive intravenous eculizumab or placebo over 6 months. In the eculizumab treatment arm, the first 10 patients received a low-dose regimen of 600 mg weekly for 4 weeks followed by 900 mg every 2 weeks until week 24, and the next 10 patients received a high-dose regimen of 900 mg weekly for 4 weeks followed by 1200 mg every 2 weeks until week 24. The placebo group was infused with saline. Patients were observed off treatment for an additional 26 weeks. Both normal-luminance and low-luminance visual acuities were measured throughout the study, and the low-luminance deficits were calculated as the difference between the letter scores. MAIN OUTCOME MEASURES: Change in area of GA at 26 weeks. RESULTS: Thirty eyes of 30 patients were enrolled. Eighteen fellow eyes also met inclusion criteria and were analyzed as a secondary endpoint. For the 30 study eyes, mean square root of GA area measurements ± standard deviation at baseline were 2.55 ± 0.94 and 2.02 ± 0.74 mm in the eculizumab and placebo groups, respectively (P = 0.13). At 26 weeks, GA enlarged by a mean of 0.19 ± 0.12 and 0.18 ± 0.15 mm in the eculizumab and placebo groups, respectively (P = 0.96). At 52 weeks of follow-up, GA enlarged by a mean of 0.37 ± 0.22 mm in the eculizumab-treated eyes and by a mean of 0.37 ± 0.21 mm in the placebo group (P = 0.93, 2 sample t test). None of the eyes converted to wet AMD. No drug-related adverse events were identified. CONCLUSIONS: Systemic complement inhibition with eculizumab was well tolerated through 6 months but did not decrease the growth rate of GA significantly. However, there was a statistically significant correlation between the low-luminance deficit at baseline and the progression of GA over 6 months.

Predicting the progression of geographic atrophy in age-related macular degeneration with SD-OCT en face imaging of the outer retina.

BACKGROUND AND OBJECTIVE: Spectral-domain optical coherence tomography (SD-OCT) en face imaging was used to measure the growth of geographic atrophy (GA) and identify baseline anatomic changes in the outer retina in eyes with nonexudative age-related macular degeneration (AMD). PATIENTS AND METHODS: In this prospective study, eyes were imaged using 200 × 200 and 512 × 128 A-scan raster patterns. Outer retinal anatomy was visualized using en face imaging of a 20-µm thick slab encompassing the inner segment/outer segment (IS/OS) band. RESULTS: En face SD-OCT imaging of the IS/OS region revealed a bilaterally symmetrical pattern of outer retinal disruption extending beyond the borders of GA that accurately predicted the progression of GA over 1 year in 13 of 30 eyes (43.3%). In the remaining cases, the area of disruption was much larger than the area of progression. CONCLUSION: En face imaging of the outer retina can predict the growth of GA in some eyes. Due to the bilateral symmetry of these findings, this imaging strategy may identify a genetic subset of patients in whom photoreceptor loss precedes the progression of GA. These areas with outer retinal disruption should be followed in clinical trials designed to test treatments for dry AMD.

Management of submacular hemorrhage secondary to neovascular age-related macular degeneration with anti-vascular endothelial growth factor monotherapy.

PURPOSE: To report the visual and anatomic outcomes of anti-vascular endothelial growth factor (VEGF) monotherapy in the management of marked submacular hemorrhage secondary to neovascular age-related macular degeneration (AMD). DESIGN: Retrospective, interventional, consecutive case series. METHODS: Nineteen eyes of 18 patients with neovascular AMD and fovea involving submacular hemorrhage comprising greater than 50% of the lesion area were treated with anti-VEGF monotherapy. Main outcome measures included mean visual acuity change from baseline, mean central lesion thickness change from baseline, mean number of injections at 6 months, and adverse events. Snellen visual acuity was converted to approximate ETDRS letter score for the purpose of statistical analysis. RESULTS: The mean change in approximate ETDRS letter score from baseline was +12 letters at 3 months (P = .003), +18 letters at 6 months (P = .001), and +17 letters at 12 months follow-up (P = .02). Seven eyes received ranibizumab, 6 eyes received bevacizumab, and 6 eyes received both at various time points. The mean number of injections at 6 months was 4.7. The mean OCT central lesion thickness decreased from 755 µm to 349 µm at 6 months follow-up (P = .0008). CONCLUSIONS: Management with anti-VEGF monotherapy may yield visual and anatomic improvements in eyes with marked submacular hemorrhage secondary to neovascular AMD.

Causes of interruption of bevacizumab therapy in age-related macular degeneration.

PURPOSE: To evaluate the rate and the causes of interruption of bevacizumab intravitreal therapy in patients with exudative age-related macular degeneration (AMD) in a referential eye-care center in Joinville, southern Brazil. METHODS: Retrospective, non-comparative, consecutive case series. Cases included all patients with exudative age-related macular degeneration who were treated with one or more bevacizumab intravitreal injections at Sadalla Amin Ghanem Eye Hospital between January, 2006 and January, 2008. Data were obtained from patients' medical records and telephone interviews. Discontinuity criterion was the absence of patient follow-up after a minimum of 3 months from the last ophthalmic examination. RESULTS: Eighty-two patients were treated. Among them, 24 (29.3%) interrupted follow-up inadvertently. The mean age was 75.2 years old (range 65-89 yo). Mean number of bevacizumab intravitreal injections was 2.0 (range 1-6). Nineteen patients answered to telephone questionnaires. The main alleged causes of discontinuity of therapy were unexpected poor visual results (8 cases, 42.1%), lack of information about followup visits (5 cases, 26.3%) and comorbidities (3 cases, 15.8%). CONCLUSIONS: A high number of patients interrupted follow-up after beginning bevacizumab therapy. Many of them related avoidable causes for discontinuity of treatment. Efforts must be done to improve education of age-related macular degeneration patients, especially in relation to functional outcomes and prolonged follow-up care.

Causes of interruption of bevacizumab therapy in age-related macular degeneration / Causas de interrupção do tratamento com bevacizumab em degeneração macular relacionada à idade

PURPOSE: To evaluate the rate and the causes of interruption of bevacizumab intravitreal therapy in patients with exudative age-related macular degeneration (AMD) in a referential eye-care center in Joinville, southern Brazil. METHODS: Retrospective, non-comparative, consecutive case series. Cases included all patients with exudative age-related macular degeneration who were treated with one or more bevacizumab intravitreal injections at Sadalla Amin Ghanem Eye Hospital between January, 2006 and January, 2008. Data were obtained from patients' medical records and telephone interviews. Discontinuity criterion was the absence of patient follow-up after a minimum of 3 months from the last ophthalmic examination. RESULTS: Eighty-two patients were treated. Among them, 24 (29.3 percent) interrupted follow-up inadvertently. The mean age was 75.2 years old (range 65-89 yo). Mean number of bevacizumab intravitreal injections was 2.0 (range 1-6). Nineteen patients answered to telephone questionnaires. The main alleged causes of discontinuity of therapy were unexpected poor visual results (8 cases, 42.1 percent), lack of information about followup visits (5 cases, 26.3 percent) and comorbidities (3 cases, 15.8 percent). CONCLUSIONS: A high number of patients interrupted follow-up after beginning bevacizumab therapy. Many of them related avoidable causes for discontinuity of treatment. Efforts must be done to improve education of age-related macular degeneration patients, especially in relation to functional outcomes and prolonged follow-up care.

OBJETIVOS: Avaliar as causas de interrupção do tratamento com bevacizumab intravítreo nos pacientes portadores da forma exsudativa de degeneração macular relacionada à idade acompanhados no Hospital de Olhos ''Sadalla Amin Ghanem'', em Joinville (SC). MÉTODOS: Série de casos retrospectiva, consecutiva e não-comparativa. Incluíram-se os pacientes com degeneração macular relacionada à idade exsudativa tratados com uma ou mais injeções intravítreas de bevacizumab entre janeiro de 2006 e janeiro de 2008. Os dados foram obtidos dos prontuários dos pacientes e de entrevistas telefônicas. O critério de descontinuação foi a ausência do paciente à consulta após o mínimo de três meses a partir da última avaliação oftalmológica. RESULTADOS: Dentre os 82 pacientes tratados, 24 interromperam o tratamento inadvertidamente (29,3 por cento). A média de idade foi 75,2 anos (65-89 anos). O número médio de injeções intravítreas de bevacizumab foi 2,0 (variação 1-6). Dezenove pacientes responderam aos questionários através de contato telefônico. As principais causas de interrupção do tratamento foram o resultado visual abaixo do esperado (8 casos, 42,1 por cento), a falta de informação sobre o controle clínico oftalmológico (5 casos, 26,3 por cento) e comorbidades sistêmicas (3 casos, 15,8 por cento). CONCLUSÃO: Um elevado número de pacientes interrompeu o acompanhamento após início de terapia intravítrea com bevacizumab. Muitos deles referiram causas evitáveis de descontinuação do tratamento. Esforços devem ser feitos para propiciar informação mais adequada aos portadores de degeneração macular relacionada à idade exsudativa em vigência deste tratamento, especialmente com relação aos resultados funcionais e acompanhamento prolongado.