Efficacy of Biweekly Ranibizumab (0.5 mg) for Exudative Macular Degeneration Retinal Edema Refractory to Anti-VEGF

• Status: Completed
• Trial end date: 2019-06-03
• Target enrollment: 0
• Participant gender: All

Summary

This is a 24 week open label study to assess the efficacy of bi-weekly ranibizumab for patients with retinal fluid due to exudative macular degeneration refractory to monthly therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southeast Clinical Research Associates, LLC
• Collaborator: Genentech, Inc.
• Treatments: Bevacizumab; Ranibizumab

Criteria

Inclusion Criteria:

• Age > 50 years

• Exudative age related macular degeneration in study eye involving the fovea

• Best Corrected Visual Acuity (by ETDRS) letter score in study eye of < 85 and > 24 (approximate Snellen equivalent 20/20 to 20/320)

• Persistent intraretinal or subretinal fluid on SD OCT despite a minimum of 5 intravitreal anti-VEGF injections administered every 4-6 weeks in the in the 6 months preceding enrollment in the study eye

• At least 30 days from last intravitreal anti-VEGF injection in the study eye

Exclusion Criteria:

• Patient who are receiving systemic anti-VEGF or proangiogenic therapy

• Patients on chronic high doses corticosteroid therapy (> than 10 mg of oral prednisone or equivalent greater than 10 days)

• Patients on chronic immunosuppressant therapy

• Patients on drugs known to have toxic side effects on the retina e.g. hydroxychloroquine

• History of intravitreal corticosteroids in study eye within 4 months of baseline

• Uncontrolled hypertension (defined as systolic >180 mm Hg and/or diastolic > 100 mm Hg while patient is sitting)

• History of stroke or APTC event in the previous year

• Any intraocular surgery in study eye within 90 days of baseline

• Presence of vitreomacular traction in study eye

• Presence of significant epiretinal proliferation in study eye

• Evidence of active infection in either eye

• Uncontrolled glaucoma in the study eye defined as a pressure > 25 mmHg on maximal medical therapy