At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Retinal and RPE Autoimmunity in AMD: Assessment of Correlation With Degree of Response to Ranibizumab Therapy
In Brief
A Phase 2 clinical trial evaluating ranibizumab (Lucentis(R)) for Age Related Macular Degeneration. Completed, enrolled 131 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
0.5 mg intravitreal injection once a month for 4 months, then as needed for 2 months