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

Southeast Clinical Research Associates

Status and phase

Completed

Phase 2

Conditions

Exudative Age Related Macular Degeneration

Treatments

Drug: Ranibizumab Injection [Lucentis]

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03071055

ML29459

Details and patient eligibility

About

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.

Full description

This is a 24 week, open-label, non-randomized, phase II study evaluating intravitreal ranibizumab dosed every 14 days in subjects with exudative macular degeneration who have persistent intraretinal or subretinal fluid despite chronic monthly anti-VEGF therapy (>6 months). Subjects must have had a minimum of 5 intravitreal anti-VEGF injections administered every 4-6 weeks in the 6 months preceding enrollment.

Consented, enrolled subjects will receive multiple open-label intravitreal injections of 0.5 mg ranibizumab administered every 14 days (± 3 days). Subjects who have resolution of fluid will convert to monthly ranibizumab for the remainder of the study. If fluid recurs, subjects will return to biweekly treatment.

Patients will be assigned to receive treatment with either ranibizumab vial or PFSs so that approximately 10 patients will be treated with each delivery method option, and syringe preparation time (SPT) will be measured by an assistant who will be observing the procedure and timing with an automated stopwatch.

Enrollment

20 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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