Back to resultsEfficacy and Safety of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD) (EXCITE)
Primary Purpose
Age Related Macular Degeneration
Status
Completed
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
Ranibizumab 0.3 mg - 3 times monthly, then quarterly
Ranibizumab 0.5 mg - 3 times monthly, then quarterly
Ranibizumab 0.3 mg monthly
Sponsored by
About this trial
This is an interventional treatment trial for Age Related Macular Degeneration focused on measuring Age-related macular degeneration, ranibizumab
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.
Sites / Locations
- Novartis
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Ranibizumab 0.3 mg - 3 times monthly, then quarterly
Ranibizumab 0.5 mg - 3 times monthly, then quarterly
Ranibizumab 0.3 mg monthly
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00275821
Brief Title
Efficacy and Safety of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
The study will test if the efficacy and safety of an alternative dosing regimen is as effective as monthly injections.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Macular Degeneration
Keywords
Age-related macular degeneration, ranibizumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
353 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ranibizumab 0.3 mg - 3 times monthly, then quarterly
Arm Type
Experimental
Arm Title
Ranibizumab 0.5 mg - 3 times monthly, then quarterly
Arm Type
Experimental
Arm Title
Ranibizumab 0.3 mg monthly
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ranibizumab 0.3 mg - 3 times monthly, then quarterly
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ranibizumab 0.5 mg - 3 times monthly, then quarterly
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ranibizumab 0.3 mg monthly
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean Change From Baseline in Best-corrected Visual Acuity of the Study Eye at Month 12
Description
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.
Time Frame
Baseline to Month 12
Secondary Outcome Measure Information:
Title
Mean Change From Baseline in the Total Lesion Area of the Study Eye at Month 12
Description
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).
Time Frame
Baseline to Month 12
Title
Mean Change From Baseline in Retinal Thickness at the Central Point of the Study Eye at Month 12
Description
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.
Time Frame
Baseline to Month 12
Title
Mean Change From Baseline in Retinal Thickness at the Central Subfield of the Study Eye at Month 12
Description
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.
Time Frame
Baseline to Month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
Novartis - Including Sites in Germany
Official's Role
Study Chair
Facility Information:
Facility Name
Novartis
City
Basel
ZIP/Postal Code
4002
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)
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