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Proposal 1514

Title of the Proposed Research

Gain of quality-adjusted life year in patients with neovascular age-related macular degeneration after anti-VEGF treatment

Lead Researcher

Park, Sang Jun

Affiliation

Department of Ophthalmology,
Seoul National University Bundang Hospital

Funding Source

None

Potential Conflicts of Interest

None

Data Sharing Agreement Date

17 November 2016

Lay Summary

Neovascular age-related macular degeneration (nAMD) is one of the leading causes of blindness, especially in developed countries. The nAMD often results in functional disability and health-related concerns such as decreased mobility, increased injuries, greater risk of depression, and increased mortality. Moreover, VI is associated with an increased risk of other concurrent chronic health conditions. Therefore, the public burden from nAMD and benefits achieved by treatments of nAMD should be estimated thoroughly and should be compared with other major chronic diseases such as hypertension, diabetes mellitus, stroke, acute myocardial infarction. However, the burden of nAMD has not been measured properly in terms of the summary measure which allows comparisons across different chronic diseases and populations. In addition, recent advance in nAMD treatment, development of anti-VEGF agent (e.g. ranibizumab), improves the vision in nAMD patients significantly, and therefore, lessens the burden from the low vision caused by nAMD. As there is a paucity of data addressing the burden of nAMD and contribution of anti-VEGF agents in the burden of nAMD in terms of a summary measure, we aim to calculate the gain of quality-adjusted life year in patients with nAMD after treatment with ranibizumab by the use of the data from the landmark RCTs, the MARINA study and ANCKOR study.

Study Data Provided

ROCHE-FVF2598G: A Phase IIIb, Multicenter, Randomized, Double Masked, SHAM Injection, Controlled Study of the Efficacy and Safety of Ranibizumab in Subjects with Subfoveal Choroidal Neovascularization (CNV) with or without Classic CNV Secondary to Age Related Macular Degeneration
ROCHE-FVF2587G: A Phase III, Placebo-Controlled, Multi-Center Study to Examine theSafety and Efficacy of Multiple-Dose Intravitreal Injections of rhuFabV2 in Subjects with Age-Related Macular Degeneration who have Predominant Classic Lesion Degeneration

Statistical Analysis Plan

Publication Citation

The publication citation will be added after the research is published.

Summary Results

Results summary or link will be posted when available.