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

Purpose

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

Condition	Intervention	Phase
Age Related Macular Degeneration	Drug: 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	Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Ranibizumab

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Mean Change From Baseline in Best-corrected Visual Acuity of the Study Eye at Month 12 [ Time Frame: Baseline to Month 12 ] [ Designated as safety issue: No ]
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:

Mean Change From Baseline in the Total Lesion Area of the Study Eye at Month 12 [ Time Frame: Baseline to Month 12 ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline to Month 12 ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline to Month 12 ] [ Designated as safety issue: No ]
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.

Enrollment:	353
Study Start Date:	December 2005
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Ranibizumab 0.3 mg - 3 times monthly, then quarterly	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.
Experimental: Ranibizumab 0.5 mg - 3 times monthly, then quarterly	Drug: 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.
Active Comparator: Ranibizumab 0.3 mg monthly	Drug: 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.

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00275821

Locations

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

Novartis - Including Sites in Germany

More Information

No publications provided

Responsible Party:	External Affairs, Novartis
ClinicalTrials.gov Identifier:	NCT00275821 History of Changes
Other Study ID Numbers:	CRFB002A2302
Study First Received:	January 11, 2006
Results First Received:	December 20, 2010
Last Updated:	February 22, 2011
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines

Keywords provided by Novartis:

Age-related macular degeneration, ranibizumab

Additional relevant MeSH terms:

Macular Degeneration
Neovascularization, Pathologic
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases

Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases

ClinicalTrials.gov processed this record on October 16, 2012

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