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Management of Neovascular Age-related Macular Degeneration: A Review on Landmark Randomized Controlled Trials.

ABSTRACT: In the last decade, a number of prospective clinical trials with carefully designed study protocols have been conducted for the treatment of neovascular age-related macular degeneration (AMD). These landmark clinical trials such as ANCHOR and MARINA and, more recently, the Comparison of AMD Treatment Trials and VIEW studies have revolutionized the management of neovascular AMD. While AMD continues to remain a leading cause of severe visual loss worldwide, advances in pharmacotherapeutics have led to substantial improvements in the outcome of these patients. The introduction of anti-vascular endothelial growth factor agents has resulted in improvement of visual outcomes and has had a positive impact on the quality of life among elderly population. While the contemporary management of neovascular AMD has been successful in tremendously reducing the visual morbidity, the financial burden of therapy has increased exponentially. To overcome these challenges, newer pharmacologic agents are evaluated for their efficacy and safety in AMD. Ground-breaking advances in bench to bedside research have led to discovery of new pathways that appear to be viable targets for preventing visual loss in AMD. In this review, study designs and results of landmark clinical trials in AMD from the past decade have been summarized.

SUBMITTER: Agarwal A

PROVIDER: S-EPMC4759900 | biostudies-other | 2016 Jan-Mar

REPOSITORIES: biostudies-other

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Management of Neovascular Age-related Macular Degeneration: A Review on Landmark Randomized Controlled Trials.

Agarwal Aniruddha A Aggarwal Kanika K Gupta Vishali V

Middle East African journal of ophthalmology 20160101 1

In the last decade, a number of prospective clinical trials with carefully designed study protocols have been conducted for the treatment of neovascular age-related macular degeneration (AMD). These landmark clinical trials such as ANCHOR and MARINA and, more recently, the Comparison of AMD Treatment Trials and VIEW studies have revolutionized the management of neovascular AMD. While AMD continues to remain a leading cause of severe visual loss worldwide, advances in pharmacotherapeutics have le ...[more]

PMID: 26957836

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Project description:PurposeTo evaluate the effect of intraocular pressure-lowering medications on treatment outcomes in the Comparison of AMD Treatments Trials.MethodsSecondary analysis of Comparison of AMD Treatments Trials data. Medication logs were reviewed for continuous 2-year use of agents that increased aqueous outflow (Group A: topical prostaglandins) or suppressed aqueous production (Group B: topical beta blockers and carbonic anhydrase inhibitors). Eyes were excluded if mixed-mechanism intraocular pressure-lowering agents or medications from more than one group were taken. Anatomical and vision responses to treatment at years 1, 2, and over the entire 2-year period in each group were compared with controls (no intraocular pressure-lowering medications).ResultsInclusion criteria were met by 28 Group A patients, 19 Group B patients, and 857 controls. After 2 years, the control group had a mean visual acuity improvement of +6.3 letters from baseline, compared with +3.5 letters in Group A (P = 0.38), and +13.8 letters in Group B (P = 0.052). Mean retinal thickness change from baseline was -54.9 μm in controls, -80.6 μm in Group A (P = 0.26), and -96.8 μm in Group B (P = 0.13). Mean total thickness change from baseline was -163 μm in controls, -180 μm in Group A (P = 0.63), and -238 μm in Group B (P = 0.08). In longitudinal analysis with adjustment by their baseline values, anti-vascular endothelial growth factor treatment drug and regimen, Group B had more visual acuity improvement (difference of 2.6 letters, 95% confidence interval: -3.4-8.5 letters), more reduction in the retinal thickness (-17.9 μm, 95% confidence interval: -36.5 to 0.7 μm), and total thickness from baseline (mean difference of -54.7 μm, 95% confidence interval: -103 to 6.2 μm) compared with the control group.ConclusionConcurrent aqueous suppressant use during anti-vascular endothelial growth factor therapy for neovascular age-related macular degeneration was associated with a trend toward greater reductions in retinal and total thickness as well as improved visual outcomes over 2 years. A similar effect was not observed to the same extent with agents that increase aqueous outflow. Because of the small sample size and secondary analysis, these findings must be cautiously interpreted and perhaps serve as a basis for future prospective studies.

Project description:PurposeTo describe outcomes 5 years after initiating treatment with bevacizumab or ranibizumab for neovascular age-related macular degeneration (AMD).DesignCohort study.ParticipantsPatients enrolled in the Comparison of AMD Treatments Trials.MethodsPatients were assigned randomly to ranibizumab or bevacizumab and to 1 of 3 dosing regimens. After 2 years, patients were released from the clinical trial protocol. At 5 years, patients were recalled for examination.Main outcome measuresVisual acuity (VA) and morphologic retinal features.ResultsVisual acuity was obtained for 647 of 914 (71%) living patients with average follow-up of 5.5 years. The mean number of examinations for AMD care after the clinical trial ended was 25.3, and the mean number of treatments was 15.4. Most patients (60%) were treated 1 time or more with a drug other than their assigned drug. At the 5-year visit, 50% of eyes had VA of 20/40 or better and 20% had VA of 20/200 or worse. Mean change in VA was -3 letters from baseline and -11 letters from 2 years. Among 467 eyes with fluorescein angiography, mean total lesion area was 12.9 mm(2), a mean of 4.8 mm(2) larger than at 2 years. Geographic atrophy was present in 213 of 515 (41%) gradable eyes and was subfoveal in 85 eyes (17%). Among 555 eyes with spectral-domain optical coherence tomography, 83% had fluid (61% intraretinal, 38% subretinal, and 36% sub-retinal pigment epithelium). Mean foveal total thickness was 278 μm, a decrease of 182 μm from baseline and 20 μm from 2 years. The retina was abnormally thin (<120 μm) in 36% of eyes. Between 2 and 5 years, the group originally assigned to ranibizumab for 2 years lost more VA than the bevacizumab group (-4 letters; P = 0.008). Otherwise, there were no statistically significant differences in VA or morphologic outcomes between drug or regimen groups.ConclusionsVision gains during the first 2 years were not maintained at 5 years. However, 50% of eyes had VA of 20/40 or better, confirming anti-vascular endothelial growth factor therapy as a major long-term therapeutic advance for neovascular AMD.

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Management of Neovascular Age-related Macular Degeneration: A Review on Landmark Randomized Controlled Trials.

Publications

Management of Neovascular Age-related Macular Degeneration: A Review on Landmark Randomized Controlled Trials.

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