Phase 2 N=131 Treatment

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

Age Related Macular Degeneration

Bottom Line

View on ClinicalTrials.gov: NCT00931489 ↗

Enrolled (actual)

131

Serious AEs

0.8%

Results posted

Jul 2017

Primary outcome: Primary: Production of Anti-Retinal Pigment Epithelium (RPE) or Anti-retinal Antibody Formation in Neovascular ("Wet") Age-related Macular Degeneration Patients Compared to Population Normals. — 31; 26; 36 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: ranibizumab (Lucentis(R)) (Drug)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Lawrence S. Morse, MD
Primary completion: Jun 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Production of Anti-Retinal Pigment Epithelium (RPE) or Anti-retinal Antibody Formation in Neovascular ("Wet") Age-related Macular Degeneration Patients Compared to Population Normals.	31; 26; 36	—
SECONDARY Change in Visual Acuity (VA) From Baseline to Month 6	10.08; 6.14	—
SECONDARY Change in Ocular Coherence Tomography (OCT) From Baseline to Month 6	-82; 22	—

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.

Eligibility Criteria

Inclusion Criteria

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 Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00931489). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.