Lucentis to Treat Pigment Epithelial Detachment
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Study ID
- NCT00841581
- Phase
- PHASE2
- Status
- Completed
Conditions
- Pigment Epithelial Detachment
Eligibility Criteria
- Sex
- ALL
- Age
- 50 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Ranibizumab — DRUGRanibizumab 0.5 mgs. (0.05 mls.) intravitreally for 6 months then as needed prn for 6 months.
Study Details
Patients with Pigment Epithelial Detachments secondary to Age-Related Macular Degeneration (AMD) will receive intravitreal Lucentis monthly for 6 months in the hope of improving visual acuity from a baseline evaluation.
Key Dates
- First listed
- Feb 11, 2009
- Start date
- Dec 31, 2008
- Status verified
- Dec 2011
- Primary completion
- Sep 30, 2011
- Completion
- Dec 31, 2011
Study Design
- Enrollment
- 32 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: LucentisAll patients receive iL for for first 6 months of study. At 6 months - patients are classified as "responders" or "non-responders". "Responders" receive iL PRN based on OCT,clinical exam etc. "Non-responders" are seen again at 12 months for repeat investigations.
Primary Outcome Measure
To investigate whether iL given monthly for 6 months in patients with Predominantly PED lesions (secondary to AMD) will significantly improve mean visual acuity from baseline on a standardized ETDRS chart. [ Time Frame: 6 months ]