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

Completed · Phase 2

Conditions studied: Age Related Macular Degeneration

In brief

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.

Key facts

Study ID

NCT00931489

Run by

Lawrence S. Morse, MD

People needed

131

Starts

2009-08-01

Expected to finish

2014-06-01

Last updated by the study team

2017-07-02

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Group 1 (Ranibizumab Responders):
• Ability to provide written informed consent and comply with study assessments for the full duration of the study
• Age > 50 years
• Patients with active neovascular "wet" AMD naïve to treatment
• Group 2 (Normal Controls):
• Age-sex-race matched to Group 1 patients
• Non-AMD
• Ability to provide written informed consent
• Group 3 (Anti-VEGF Initial Non-responders):
• "Wet" AMD patient treated with 4 or more monthly injections of anti-VEGF treatment without an adequate response (persistent fluid on OCT)
• Ability to provide written informed consent and comply with study assessments for the full duration of the study
• Age > 50 years
• Group 4 ("Dry" AMD):
• Age-sex-race matched to Group 1 patients
• "Dry" AMD, category 2 or 3 by AREDS (Age-Related Eye Disease Study) criteria
• Ability to provide written informed consent

You may not qualify if…

• Pregnancy (positive pregnancy test) or lactation
• Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
• Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
• Participation in another simultaneous medical investigation or trial
• Concurrent eye disease in the study eye that could compromise visual acuity (e.g., diabetic retinopathy, advanced glaucoma)
• Previous AMD therapy
• Patients being treated for autoimmune or other disease with immunomodulatory drugs (i.e., prednisone, infliximab, methotrexate)
• Patients with recent (less than 6 months) ocular or systemic surgery

Where it is running

• University of California, Davis — Sacramento, California, United States

Full record on ClinicalTrials.gov

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