Status:
COMPLETED
Efficacy and Safety of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)
Lead Sponsor:
Novartis
Conditions:
Age Related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
The study will test if the efficacy and safety of an alternative dosing regimen is as effective as monthly injections.
Eligibility Criteria
Inclusion
- Patients with primary or recurrent subfoveal CNV secondary to AMD, including those with predominantly classic, minimally classic or occult lesions with no classic component
- Patients who have a BCVA score between 73 and 24 letters, inclusively, in the study eye using ETDRS-like grading charts (approximately 20/40 to 20/320)
Exclusion
- Prior treatment in the study eye with verteporfin, external-beam radiation therapy, subfoveal focal laser photocoagulation, vitrectomy, or transpupillary thermotherapy.
- History of submacular surgery or other surgical intervention for AMD in the study eye, glaucoma filtration surgery, corneal transplant surgery.
- Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within one month preceding Baseline.
- Other protocol-defined inclusion/exclusion criteria applied to the study.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
353 Patients enrolled
Trial Details
Trial ID
NCT00275821
Start Date
December 1 2005
End Date
January 1 2008
Last Update
March 16 2011
Active Locations (1)
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1
Novartis
Basel, Switzerland, 4002