drugset / Trial / NCT00931489

Retinal and Retinal Pigment Epithelium (RPE) Autoimmunity in Age-related Macular Degeneration (AMD)

NCT00931489

Phase 2 Completed 131 enrolled Lawrence S. Morse, MD Genentech, Inc. · collab
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The investigators hope to determine if "wet" AMD patients differ from patients with "dry" AMD or normal eyes in the production of anti-retinal pigment epithelium (anti-RPE) or anti-retinal antibody formation. To explain: the immune system can make antibodies that attack our own cells, specifically the RPE and the retina. Normally the RPE and retinal cells are ignored by the immune system, but when disease occurs, immune reactions can occur, making an autoantibody that can attack the patient's own cells and make things worse. This production of autoantibodies that react with our own RPE and retinal cells is what the investigators want to test in this proposal to see if they may contribute to, or are responsible for, a poor response to treatment. The investigators also want to know how those patients who initially respond to the standard-of-care treatment, ranibizumab injections, differ in the production of anti-RPE or anti-retinal antibody formation, from those patients who do not respond initially after 4 consecutive injections.

Timeline

Start
2009-08
Primary completion
2014-06
Completion
2014-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ranibizumab Monoclonal antibody 0.5 mg Intravitreal