The NEI supports a number of activities to bridge the gap between the proposed human application of a discovery, and new medicines, devices, or surgeries work in people. NEI also collaborates with the Food and Drug Administration (FDA) to facilitate the ophthalmic regulatory approval process.
The Age-Related Eye Disease Study (AREDS) is a major clinical trial sponsored by the NEI to evaluate the effect of nutritional supplements on the progression of age-related macular degeneration (AMD) and cataract.
The NEI uses a number of funding mechanisms to support clinical trials through conception, protocol development, recruitment and retention, treatment and follow-up, and close out. NEI also supports research networks to facilitate clinical trials in specific disease areas, such as pediatric eye disease and diabetic retinopathy.
FDA/NEI Clinical Trial Endpoints Symposia
- Use of Functional Vision Endpoints in Visual Prostheses Product Development, May 2011
- Glaucoma Clinical Trial Design and Endpoints Symposium: Measures of Structural Change and Visual Function, September 2010
- Use of Patient-reported Outcomes in Medical Product Development, October 2009
- Glaucoma Clinical Drug Trial Design and Endpoints, March 2008
- Ophthalmic Clinical Trial Design and Endpoints (AMD and Diabetic Retinopathy), November 2006