Lucentis for Age-related Macular Degeneration Pigment Epithelial Detachments
Completed · Phase 2/Phase 3
Conditions studied: Age-related Macular Degeneration, Pigment Epithelial Detachment, Neovascular Macular Degeneration, Wet Macular Degeneration
In brief
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.
Key facts
- Study ID
- NCT00590694
- Run by
- Pacific Eye Associates
- People needed
- 15
- Starts
- 2006-10-01
- Expected to finish
- 2009-12-01
- Last updated by the study team
- 2012-04-12
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Pacific Eye Associates — San Francisco, California, United States
Full record on ClinicalTrials.gov
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