Seven-year outcomes following intensive anti-vascular endothelial growth factor therapy in patients with exudative age-related macular degeneration.

BACKGROUND: Anti-vascular endothelial growth factor (VEGF) therapy is currently the most effective therapy of exudative age-related macular degeneration (AMD). The aim of this study was to assess long-term benefits of intensive aflibercept and ranibizumab anti-VEGF therapy in patients with exudative AMD. METHODS: Two clinical trial sites recruited their original subjects for a re-evaluation 7 years after the baseline visit of the phase-3 Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration (VIEW 2) trial. Forty-seven eyes of 47 patients with AMD originally treated with ranibizumab (14 eyes) or aflibercept (33 eyes) were included. RESULTS: Mean number of injections was 17.8 ± 3.0 during participation in the VIEW 2 trial. Fourteen of 47 (30%) eyes were given additional injections with a mean number of 5.7 ± 4.5 after the trial. At a mean follow-up time of 82 ± 5 months best corrected visual acuity (BCVA) remained stable or improved (≤ 10 letters lost) in 55% of patients in the entire study population, in 43% in the ranibizumab group and in 60% in the aflibercept group. In both groups combined mean BCVA was 54 ± 13 letters at baseline, 65 ± 17 letters at the end of the intensive phase and 45 ± 25 letters at the end of follow-up. There was no statistically significant difference in BCVA between the two groups at baseline (p = 0.88) and at the end of follow-up (p = 0.40). Macular atrophy was observed in 96% of eyes, average area was 7.22 ± 6.31 mm2 with no statistically significant difference between groups (p = 0.47). Correlation between BCVA at end-of-follow-up and the area of atrophy was significant (p < 0.001). At the end of follow-up, fluid was detected in 7 of 47 eyes (15%) indicating disease activity. CONCLUSION: Long-term efficacy of aflibercept and ranibizumab was largely consistent. Following a two-year intensive therapy with as-needed regimen, BCVA was maintained or improved in almost half of the patients and in the ranibizumab group and more than half of the patients in the aflibercept group with very few injections. In a remarkable proportion of eyes, BCVA declined severely which underlines the need for long-term follow-ups and may indicate a more prolonged intensive therapy. TRIAL REGISTRATIONS: VIEW 2 study: ClinicalTrials.gov ID: NCT00637377, date of registration: March 18, 2008. Long-term follow-up: IRB nr.: SE RKEB 168/2022, ClinicalTrials.gov ID: NCT05678517, date of registration: December 28, 2022, retrospectively registered.

Cataract blindness in Hungary.

AIM: To estimate the prevalence of blindness and visual impairment resulting from cataract in the population aged ≥50y in Hungary, and to assess the cataract surgical services. METHODS: A rapid assessment of avoidable blindness (RAAB) was conducted. A total of 3523 eligible people were randomly selected and examined. Each participant underwent surgery for cataract was interviewed with regard to the year, place, and costs of the surgery. Participants with obvious cataract were asked why they had not yet undergone surgery (barriers to surgery). RESULTS: An estimated 12 514 people were bilaterally blind; the visual acuity (VA) in 19 293 people was <6/60, and the VA in 73 962 people was <6/18 in the better eye due to cataract. An estimated 77 933 eyes are blind; 98 067 eyes had a VA of <6/60, and an estimated 277 493 eyes had a VA of <6/18 due to cataract. Almost all cataract surgeries were conducted in government hospitals. The age- and sex-adjusted cataract surgical coverage with VA<3/60 in eyes was 90.0%. The rate of good visual outcome after surgery was 79.5%. Ocular comorbidity was the main cause of poor outcome (78.1%), followed by late complications (such as posterior capsule opacification) (17.2%), inadequate optical correction (3.1%), and surgical complications (1.6%). The main barrier to surgery in people with bilateral cataract and VA of <6/60 was 'need not felt'. CONCLUSION: The prevalence of visual impairment resulting from cataract is slightly higher than expected. The quality of the cataract surgical service seems adequate in Hungary. However, the number of cataract operations per year should continue to increase due to the increasing patient demands and the aging population.

Feasibility of the rapid assessment of avoidable blindness with diabetic retinopathy module (RAAB+DR) in industrialised countries: challenges and lessons learned in Hungary.

PURPOSE: To present experiences gained during the planning, implementation, and practical performance of the rapid assessment of avoidable blindness with diabetic retinopathy module (RAAB+DR) in an established market economy. METHODS: A total of 3523 people aged 50 years or older were examined at their homes in 105 randomly selected clusters in Hungary. During the 4-month-long field work, five teams visited the clusters. Each team was composed of a senior ophthalmic resident or eye specialist, a nurse, an assistant, a driver, and a local guide. The local guides were found through local mayors of the towns or villages or other local leaders. RESULTS: Of all 105 clusters, 41% were completed in 1 day and 59% required a longer stay. The shortest daily examination time was 3.5 hours and the longest was 10 hours. Altogether, 7.6% of the enumeration areas needed revisit, mainly due to insufficient preparatory work and absence of the subjects. The best local guides were the local government workers, health visitors, and general practitioner (GP) nurses. Refusal of pupillary dilatation was relatively high and varied greatly among the study groups (7.7-43.8%). CONCLUSION: The performance of a RAAB+DR study in a well-industrialised country is difficult, but may be successful. The most critical factor for success is an excellent local guide who is able to achieve participation of the people. The results of the RAAB are a solid basis for the development of a national programme for universal eye health and to prepare active media campaigns.

Visual impairment and blindness in Hungary.

AIM: The aim of this study was to estimate the prevalence and causes of blindness, severe visual impairment (SVI), moderate visual impairment (MVI), and early visual impairment (EVI) and its causes in an established market economy of Europe. DESIGN: A cross-sectional population-based survey. METHODS: A sample size of 3675 was calculated using the standard Rapid Assessment of Avoidable Blindness (RAAB) software in Hungary. A total of 105 clusters of 35 people aged 50 years or older were randomly selected with probability proportionate to size by the Hungarian Central Statistical Office. Households within the clusters were selected using compact segment sampling. Visual acuity (VA) was assessed with a Snellen tumbling E-chart with or without a pinhole in the households. RESULTS: The adjusted prevalences of bilateral blindness, SVI, MVI and EVI were 0.9% (95% CI: 0.6-1.2), 0.5% (95% CI: 0.2-0.7), 5.1% (95% CI: 4.3-5.9) and 6.9% (95% CI: 5.9-7.9), respectively. The major causes of blindness in Hungary were age-related macular degeneration (AMD; 27.3%) and other posterior segment diseases (27.3%), cataract (21.2%) and glaucoma (12.1%). Cataract was the main cause of SVI, MVI and EVI. Cataract surgical coverage (CSC) was 90.7%. Of all bilateral blindness in Hungary, 45.5% was considered avoidable. CONCLUSION: This study proved that RAAB methodology can be successfully conducted in industrialized countries, which often lack reliable epidemiologic data. The prevalence of blindness was relatively low, with AMD and other posterior segment diseases being the leading causes, and cataract is still a significant cause of visual impairment.

[Intravitreal ranibizumab therapy for choroidal neovascularization secondary to pathological myopia]. / Patológiás myopia talaján kialakult érújdonképzodés intravitrealis ranibizumabkezelése.

INTRODUCTION: Pathological myopia is one of the leading causes of vision loss worldwide, especially among young people of working age. Choroidal neovascularization is one of the most important cause of visual impairment in pathological myopia. AIM: To evaluate the efficacy of intravitreal ranibizumab for the treatment of myopic choroidal neovascularization. METHOD: In this retrospective analysis 14 eyes of 14 patients (mean age: 61 ± 17 years) with myopic choroidal neovascularization were treated with intravitreal ranibizumab as needed. Best-corrected visual acuity, thickness of choroidal neovascularization lesion and the number of injections were assessed. RESULTS: The mean visual acuity changed from 55.8 ± 19.3 letters to 64.8 + 15.5 at 12 months (p = 0.0414), and 62.6 ± 16.3 during follow-up time (p = 0.2896). Mean follow-up time was 19.7 ± 23.9 months, average number of injections was 2.8 ± 2.1. Visual acuity declined in four patients despite the treatment. CONCLUSIONS: Intravitreal ranibizumab is an effective therapy in pathological myopia. Some patients experience deterioration of visual acuity despite of treatment. Orv. Hetil., 2017, 158(15), 579-586.

[Regional disparities in the prevalence of diabetes and diabetic retinopathy in Hungary in people aged 50 years and older]. / Cukorbetegség és retinopathia diabetica regionális egyenlotlenségei Magyarországon az 50 éves és idosebb korú lakosság körében.

INTRODUCTION: Diabetes mellitus (DM) is one of the main causes of blindness among persons aged 50 years and older. AIM: The purpose of our survey was to estimate the prevalence of DM and diabetic retinopathy (DR), as well as to assess the coverage of diabetic eye care services in different regions of Hungary. METHOD: In 105 clusters, 3675 people aged 50 years and older were included in the survey. The standardized rapid assessment of avoidable blindness (RAAB) with the diabetic retinopathy module (DRM) was used to examine the participants. Thereafter, differences between West-, Middle- and East-Hungary were analysed. RESULTS: Prevalence of DM was higher in East-Hungary (20.9%), than in West- (19.5%) and in Middle-Hungary (19.5%). Prevalence od DR was higher in West-Hungary (24.1%), than in Middle- (17.8%) and in East-Hungary (19.6%). Proportion of participants who never had a fundus examination for DR was the lowest in Middle-Hungary (19.1%). CONCLUSIONS: Primary care should be strenghten mainly in country settlements or telemedical eye screening program should be started to decrease the prevalence of diabetic eye complications. Orv. Hetil., 2017, 158(10), 362-367.

Diabetes and diabetic retinopathy in people aged 50†years and older in Hungary.

BACKGROUND/AIMS: The purpose of this study was to estimate the prevalence of diabetes mellitus (DM) and diabetic retinopathy (DR) in the population aged 50 years and older in Hungary, and to assess the coverage of diabetic eye care services. METHODS: In total, 105 clusters of 35 people aged 50 years or older were randomly selected. The standardised rapid assessment of avoidable blindness (RAAB) with the diabetic retinopathy module (DRM) was used. Participants were classified as having DM if they were known to have DM or if their random blood glucose level was ≥200 mg/dL. Dilated fundus examination and Scottish DR grading were performed. RESULTS: In total, 3523 (95.9%) out of 3675 eligible subjects were examined. And 705 (20.0%) out of 3523 had known (661) or newly diagnosed DM (44). Twenty per cent of participants with known DM had a blood glucose level ≥200 mg/dL, and 27.4% had never had an ophthalmological examination for DR. Prevalence of DR and/or maculopathy was 20.7% and prevalence of sight-threatening DR (STDR) was 4.3% in one or both eyes among participants with DM. CONCLUSIONS: Prevalence of DM was in line with findings of other RAAB+DRM surveys and slightly lower than the unpublished earlier age-matched Hungarian estimate. Prevalence of DR was slightly lower than expected. The prevalence of STDR was low in people aged 50 years and older in Hungary compared with the results of other RAAB with DRM surveys. DR screening coverage was low. To prevent severe complications of DM and possible concomitant visual loss, the coverage of ophthalmic examinations in patients with DM should be increased.

[Long-term treatment with intravitreal ranibizumab for exudative age-related macular degeneration]. / Hosszú távú intravitrealis ranibizumabkezelés exsudativ idoskori maculadegenerációban.

INTRODUCTION: The results of intravitreal ranibizumab treatment for exsudative age-related macular degeneration have been favourable until this time. AIM: To evaluate the two-year functional and anatomic results of intravitreal ranibizumab treatment. METHOD: 46 patients (age: 75 ± 9.1 years) were included in a prospective single center study. Treatment regimen was the following: monthly 0.5 mg ranibizumab was administered in the first 3 months, and later as required (pro re nata). The change of best corrected visual acuity and central retinal thickness was followed. RESULTS: The visus change at the end of the follow-up time was not statistically significant compared to baseline (p = 0.760) and the at the end of the first year (p = 0.154). Central retinal thickness decreased significantly compared to baseline (p = 0.000001), but the change was not statistically significant compared to the end of the first year (p = 0.875). CONCLUSIONS: Patients with neovascular macular degeneration treated with intravitreal ranibizumab using pro re nata regimen have stable visus for long term, and the exsudation could be reduced efficiently.