Lucentis for Age-related Macular Degeneration Pigment Epithelial Detachments

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients with neovascular Age-related macular degeneration (AMD) and the particular feature of pigment epithelial detachments (PEDs) were not studied in the Phase III trials for ranibizumab (Lucentis). The PrONTO study was the first ranibizumab study to enroll such patients but only treated with ranibizumab until fluid within the layers of the retina was absent, not until the entire PED was absent. This study hypothesizes that there may be a difference in benefit between patients treated until just the retinal edema is gone and those in which the retinal edema and PED are both gone.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pacific Eye Associates
• Collaborator: Genentech, Inc.
• Treatments: Ranibizumab

Criteria

Inclusion Criteria:

• Neovascular age-related macular degeneration patients over age 50

• Presence of a pigment epithelial detachment on optical coherence tomography

• Initial or recurrent disease

• Previous treatment allowed

• Visual acuity between Snellen 20/40 - 20/400

Exclusion Criteria:

• More than three previous treatments with PDT or other radiation/laser therapy

• Previous vitrectomy or other AMD surgical intervention

• Severe scarring or severe concurrent ocular disease (uncontrolled glaucoma)

Patients eligible for the study are randomized into one of two groups. Group 1 receives injections of ranibizumab until retinal edema is resolved. Group 2 receives ranibizumab injections until both retinal edema and the PED are resolved. Study duration is one year with visits once per month.