NCT00275821CompletedPhase 3
A Randomized, Double-masked, Active-controlled, Multi-center Study Comparing the Efficacy and Safety of Ranibizumab Administered as Two Dosing Regimens in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Novartis
- Enrollment
- 353
- Locations
- 1
- Primary Endpoint
- Mean Change From Baseline in Best-corrected Visual Acuity of the Study Eye at Month 12
Study Overview
Brief Summary
The study will test if the efficacy and safety of an alternative dosing regimen is as effective as monthly injections.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Arms & Interventions
Ranibizumab 0.3 mg - 3 times monthly, then quarterly
Experimental
Intervention: Ranibizumab 0.3 mg - 3 times monthly, then quarterly (Drug)
Ranibizumab 0.5 mg - 3 times monthly, then quarterly
Experimental
Intervention: Ranibizumab 0.5 mg - 3 times monthly, then quarterly (Drug)
Ranibizumab 0.3 mg monthly
Active Comparator
Intervention: Ranibizumab 0.3 mg monthly (Drug)
Outcomes
Primary Outcomes
Mean Change From Baseline in Best-corrected Visual Acuity of the Study Eye at Month 12
Time Frame: Baseline to Month 12
Visual acuity (VA) was assessed in both eyes at each study visit using best correction determined from protocol refraction. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at an initial testing distance of 4 meters.
Secondary Outcomes
- Mean Change From Baseline in the Total Lesion Area of the Study Eye at Month 12(Baseline to Month 12)
- Mean Change From Baseline in Retinal Thickness at the Central Point of the Study Eye at Month 12(Baseline to Month 12)
- Mean Change From Baseline in Retinal Thickness at the Central Subfield of the Study Eye at Month 12(Baseline to Month 12)
Investigators
Study Sites (1)
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