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

NCT00275821 | Completed Phase 3 Results

• 1 other identifier: CRFB002A2302
• Study Type: interventional
• Target: 353
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Age Related Macular Degeneration

Keywords

Age-related macular degeneration, ranibizumab

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in Best-corrected Visual Acuity of the Study Eye at 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.

  Baseline to Month 12

Secondary Outcomes (3)

• 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

Study Arms (3)

Ranibizumab 0.3 mg - 3 times monthly, then quarterly

EXPERIMENTAL

Drug: Ranibizumab 0.3 mg - 3 times monthly, then quarterly

Ranibizumab 0.5 mg - 3 times monthly, then quarterly

EXPERIMENTAL

Drug: Ranibizumab 0.5 mg - 3 times monthly, then quarterly

Ranibizumab 0.3 mg monthly

ACTIVE COMPARATOR

Drug: Ranibizumab 0.3 mg monthly

Interventions

Ranibizumab 0.3 mg - 3 times monthly, then quarterly DRUG

Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.

Ranibizumab 0.3 mg - 3 times monthly, then quarterly

Ranibizumab 0.5 mg - 3 times monthly, then quarterly DRUG

Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.

Ranibizumab 0.5 mg - 3 times monthly, then quarterly

Ranibizumab 0.3 mg monthly DRUG

Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.

Ranibizumab 0.3 mg monthly

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis

Basel, 4002, Switzerland

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis

  Novartis - Including Sites in Germany

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 11, 2006
• First Posted: January 12, 2006
• Study Start: December 1, 2005
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: March 16, 2011
• Results First Posted: March 16, 2011

Record last verified: 2011-02

Locations

CH (1)