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

Completed · Phase 2

Conditions studied: Exudative Age Related Macular Degeneration

In brief

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.

Key facts

Study ID

NCT03071055

Run by

Southeast Clinical Research Associates, LLC

People needed

20

Starts

2017-10-01

Expected to finish

2019-06-03

Last updated by the study team

2020-10-22

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Charlotte Eye Ear Nose and Throat Associates, PA — Charlotte, North Carolina, United States
• Charlotte Eye Ear Nose and Throat Associates, PA — Statesville, North Carolina, United States

Full record on ClinicalTrials.gov

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