Status:
COMPLETED
Retinal and Retinal Pigment Epithelium (RPE) Autoimmunity in Age-related Macular Degeneration (AMD)
Lead Sponsor:
Lawrence S. Morse, MD
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Age Related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief 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 fo...
Detailed Description
Up to 10% of patients with neovascular AMD treated with ranibizumab respond poorly or worsen despite therapy. The reason for this lack of response is unclear. We have preliminary data that suggests ab...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT00931489
Start Date
August 1 2009
End Date
June 1 2014
Last Update
July 2 2017
Active Locations (1)
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1
University of California, Davis
Sacramento, California, United States, 95817