Phase 3
Completed N=353
Efficacy and Safety of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)
Source: ClinicalTrials.gov NCT00275821 ↗Enrolled (actual)
353
Serious AEs
16.4%
Results posted
Mar 2011
Primary outcomePrimary: Mean Change From Baseline in Best-corrected Visual Acuity of the Study Eye at Month 12 — 4.9; 3.8; 8.3 letters
Summary
The study will test if the efficacy and safety of an alternative dosing regimen is as effective as monthly injections.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Best-corrected Visual Acuity of the Study Eye at Month 12 |
4.9; 3.8; 8.3 | — |
| SECONDARY Mean Change From Baseline in the Total Lesion Area of the Study Eye at Month 12 |
-0.21; -1.51; -1.28 | — |
| SECONDARY Mean Change From Baseline in Retinal Thickness at the Central Point of the Study Eye at Month 12 |
-96.0; -105.6; -105.3 | — |
| SECONDARY Mean Change From Baseline in Retinal Thickness at the Central Subfield of the Study Eye at Month 12 |
-93.3; -97.5; -97.9 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00275821). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.