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

Part of paid clinical trials in Sacramento, California.

Sponsor
Lawrence S. Morse, MD
Study ID
NCT00931489
Phase
PHASE2
Status
Completed

Conditions

  • Age Related Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Accepted

Interventions

Study Details

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 Dates

First listed
Jul 2, 2009
Start date
Aug 31, 2009
Status verified
Jun 2017
Primary completion
Jun 30, 2014
Completion
Jun 30, 2014

Study Design

Enrollment
131 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Wet AMD Patients Responders
    Dilated eye exam once a month for 7 months; visual acuity and OCT once a month for 7 months; Lucentis(R)/ranibizumab injection once each month for the Baseline and Month 1-3 visits, then as needed at Month 4 and 5; 3 Tbls. blood draw at Baseline, Month 3 and Month 6 visits.
  • No Intervention: Normal Population
    Dilated eye exam and 3 Tbls. blood draw at first and only study visit.
  • Active Comparator: Wet AMD Patients Acute Non-responders
    Participants in this Group will have not responded to 4 prior injections of Lucentis(R)/ranibizumab or other anti-VEGF treatment. Dilated eye exam at Month 4; visual acuity and OCT at Months 4-6; injection of anti-VEGF treatment as needed at Months 4 and 5; 3 Tbls. blood draw at Month 4
  • No Intervention: Dry AMD Population
    Dilated eye exam and 3 Tbls. blood draw at first and only study visit.
  • Active Comparator: Wet AMD Patients Chronic Non-responderes
    Participants in this Group will have not responded to 4 or more prior injections of Lucentis(R)/ranibizumab or other anti-VEGF treatment. One visit at Month 4: Dilated eye exam with visual acuity and OCT; injection of anti-VEGF as needed; 3 Tbls. blood drawn

Primary Outcome Measure

Production of Anti-Retinal Pigment Epithelium (RPE) or Anti-retinal Antibody Formation in Neovascular ("Wet") Age-related Macular Degeneration Patients Compared to Population Normals. [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, DavisSacramentoCalifornia95817-

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By research site
University of California, Davis· Sacramento, CA

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