NCT03071055

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

Efficacy of Biweekly Ranibizumab (0.5 mg) for Exudative Macular Degeneration Retinal Edema Refractory to Anti-VEGF Therapy Comparing Syringe Preparation Time Using Ranibizumab Vial and Pre-filled Syringe

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Southeast Clinical Research Associates, LLC · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Exudative Age Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	Ranibizumab Injection [Lucentis]	intravitreal injection

Timeline

• Start date: 2017-10-01
• Primary completion: 2019-06-03
• Completion: 2019-06-03
• First posted: 2017-03-06
• Last updated: 2020-10-22

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study