Phase 3 N=353 Randomized Double-blind Treatment

Efficacy and Safety of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)

Age Related Macular Degeneration

Bottom Line

View on ClinicalTrials.gov: NCT00275821 ↗

Enrolled (actual)

353

Serious AEs

16.4%

Results posted

Mar 2011

Primary outcome: Primary: Mean Change From Baseline in Best-corrected Visual Acuity of the Study Eye at Month 12 — 4.9; 3.8; 8.3 letters

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Ranibizumab 0.3 mg - 3 times monthly, then quarterly (Drug); Ranibizumab 0.5 mg - 3 times monthly, then quarterly (Drug); Ranibizumab 0.3 mg monthly (Drug)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Novartis
Primary completion: Jan 2008

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	—

Summary

The study will test if the efficacy and safety of an alternative dosing regimen is as effective as monthly injections.

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.

View full record on ClinicalTrials.gov →

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.