Efficacy of Fixed Monthly Dosing of Ranibizumab in Neovascular Age-related Macular Degeneration

• Status: Completed
• Trial end date: 2017-08-21
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this pilot study is to evaluate the efficacy of intensive fixed monthly dosing of intravitreal Lucentis® (Ranibizumab) for the treatment of SRF and PED in neovascular AMD which is persistent to anti-VEGF (anti-vascular endothelial growth factor) monotherapy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Ranibizumab

Criteria

Key inclusion criteria

1. Ability to provide written informed consent and comply with study assessments for the full duration of the study.

2. Age equal to or older than 50 years.

3. Presence of SRF associated with PED in neovascular AMD (proven with OCT FA, and ICG) which is persistent despite consecutive anti-VEGF injections for at least 9 months (3 initial loading doses with 4 week interval followed by PRN regimen)

• A "persistent PED" is defined as a subject with < 50% reduction or increase in PED height

Key exclusion criteria

1. Administration of periocular, intravitreal, or systemic corticosteroid within 3 months prior to visit 1 in the study eye

2. Prior treatment with photodynamic therapy in the study eye

3. Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye

4. Previous submacular surgery in the study eye

5. History of vitrectomy in the study eye

6. Epiretinal membranes (ERM)

7. Submacular hemorrhage or fibrosis within 50% of entire PED.