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

Age Related Macular Degeneration Clinical Trial

— EXCITE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00275821
• Other study ID #: CRFB002A2302
• Status: Completed
• Phase: Phase 3
• First received: January 11, 2006
• Last updated: February 22, 2011
• Start date: December 2005
• Est. completion date: January 2008

Study information

• Verified date: February 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 353
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Choroidal Neovascularization
• Macular Degeneration
• Neovascularization, Pathologic

Intervention

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

Locations

Country	Name	City	State
Switzerland	Novartis	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Mean Change From Baseline in the Total Lesion Area of the Study Eye at 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).	Baseline to Month 12	No
Secondary	Mean Change From Baseline in Retinal Thickness at the Central Point of the Study Eye at 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.	Baseline to Month 12	No
Secondary	Mean Change From Baseline in Retinal Thickness at the Central Subfield of the Study Eye at 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.	Baseline to Month 12	No