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Gain of quality-adjusted life year in patients with neovascular age-related macular degeneration after anti-VEGF treatment
Proposal
1514
Title of 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
[{ "PostingID": 3809, "Title": "ROCHE-FVF2598G", "Description": "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
Medicine: ranibizumab, Condition: Neovascular Age-related Macular Degeneration, Phase: 3, Clinical Study ID: FVF2598G, Sponsor: Roche" },{ "PostingID": 3815, "Title": "ROCHE-FVF2587G", "Description": "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
Medicine: ranibizumab, Condition: Neovascular Age-related Macular Degeneration, Phase: 3, Clinical Study ID: FVF2587G, Sponsor: Roche" }]
Statistical Analysis Plan
The statistical analysis plan will be added after the research is published.
Publication Citation
The publication citation will be added after the research is published.
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