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

Phase 3

Completed

• Conditions: Age Related Macular Degeneration
• Interventions: Drug: Ranibizumab 0.5 mg - 3 times monthly, then quarterly; Drug: Ranibizumab 0.3 mg - 3 times monthly, then quarterly; Drug: Ranibizumab 0.3 mg monthly

• Registration Number: NCT00275821
• Lead Sponsor: Novartis

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2006-01-11
• Study First Submitted QC: 2006-01-11
• Study First Posted: 2006-01-12
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Results First Submitted: 2010-12-20
• Status Verified: 2011-02
• Results First Submitted QC: 2011-02-22
• Last Update Submitted: 2011-02-22
• Results First Posted: 2011-03-16
• Last Update Posted: 2011-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 353

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)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ranibizumab 0.5 mg - 3 times monthly, then quarterly	Ranibizumab 0.5 mg - 3 times monthly, then quarterly	-
Ranibizumab 0.3 mg - 3 times monthly, then quarterly	Ranibizumab 0.3 mg - 3 times monthly, then quarterly	-
Ranibizumab 0.3 mg monthly	Ranibizumab 0.3 mg monthly	-

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Best-corrected Visual Acuity of the Study Eye at Month 12	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 Outcome Measures

Name	Time	Method
Mean Change From Baseline in the Total Lesion Area of the Study Eye at Month 12	Baseline to Month 12	Fluorescein angiography was conducted in conjunction with color fundus photography at screening and at Months 6 and 12. Investigators used digital fluorescein angiograms to determine presence or absence of choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).
Mean Change From Baseline in Retinal Thickness at the Central Point of the Study Eye at Month 12	Baseline to Month 12	Optical Coherence Tomography (OCT) was performed on both eyes at screening and monthly from baseline through Month 12 prior to study drug administration. OCT images were evaluated at the central reading center (CRC) by trained graders and ophthalmologists experienced in clinical trials.
Mean Change From Baseline in Retinal Thickness at the Central Subfield of the Study Eye at Month 12	Baseline to Month 12	Optical Coherence Tomography (OCT) was performed on both eyes at screening and monthly from baseline through Month 12 prior to study drug administration. OCT images were evaluated at the central reading center (CRC) by trained graders and ophthalmologists experienced in clinical trials.

Trial Locations

Locations (1)

Novartis; 🇨🇭 Basel, Switzerland