Ophthalmology
Statistics Collaborative, Inc. (SCI) has extensive experience working with clinical trials involving ophthalmological disorders. These underlying diseases have included diabetes as well as age-related disorders such as age-related macular degeneration (AMD). For clinical trials in ophthalmology, SCI has served as the statistical organization reporting to Data Monitoring Committees (DMCs) as well as the statistical member of the boards.
Dr. Wittes has served variously as the statistical member or as the Chair of the DMC for trials sponsored by the NEI. Illnesses have included AMD and cataracts (the Age-Related Eye Disease Study [AREDS] and the Age-Related Eye Disease Study 2 [AREDS2]), uveitis, and retinitis pigmentosa.
Ophthalmological disorders present unique statistical challenges because of their many outcomes and the paired nature of the data (with each subject having two eyes). SCI has designed unique graphical presentations to summarize changes over time in these multivariate data.
Examples of SCI’s work in ophthalmology:
- Age-related macular degeneration (AMD): SCI acted as the reporting statistical group for the Minimally Classic/Occult Trial of the Anti-VEGF Antibody Ranibizumab in the Treatment of Neovascular Age-Related Macular Degeneration (MARINA) and the Anti-VEGF Antibody for the Treatment of Predominantly Classic Choroidal Neovascularization in Age-Related Macular Degeneration (ANCHOR) trial, both Phase 3. We presented both safety and efficacy to the DMC. The reports of these trials appear in The New England Journal of Medicine.
- Retinopathy and macular edema: SCI served as the reporting statistical group for the DMC for a trial evaluating treatment for an eye disorder related to diabetes.
- Ophthalmologic devices: SCI has provided statistical consulting and analysis for a number of trials studying devices to correct vision in various eye diseases.