Lucentis for Age-related Macular Degeneration Pigment Epithelial Detachments
NCT00590694 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2012-04-12
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.
Conditions
- Age-related Macular Degeneration
- Pigment Epithelial Detachment
- Neovascular Macular Degeneration
- Wet Macular Degeneration
Interventions
- DRUG
-
0.5mg injection monthly according to protocol for one year
Sponsors & Collaborators
-
Genentech, Inc.
collaborator INDUSTRY -
Pacific Eye Associates
lead OTHER
Principal Investigators
-
Anne Fung, MD · Pacific Eye Associates / California Pacific Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-10-31
- Primary Completion
- 2009-12-31
- Completion
- 2009-12-31
Countries
- United States
Study Locations
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