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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00275821
First received: January 11, 2006
Last updated: February 22, 2011
Last verified: February 2011

January 11, 2006
February 22, 2011
December 2005
January 2008   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00275821 on ClinicalTrials.gov Archive Site
  • 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.
Not Provided
Not Provided
Not Provided
 
Efficacy and Safety of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)
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

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Age Related Macular Degeneration
  • 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.
  • 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.
  • 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.
  • Experimental: Ranibizumab 0.3 mg - 3 times monthly, then quarterly
    Intervention: Drug: Ranibizumab 0.3 mg - 3 times monthly, then quarterly
  • Experimental: Ranibizumab 0.5 mg - 3 times monthly, then quarterly
    Intervention: Drug: Ranibizumab 0.5 mg - 3 times monthly, then quarterly
  • Active Comparator: Ranibizumab 0.3 mg monthly
    Intervention: Drug: Ranibizumab 0.3 mg monthly
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
353
January 2008
January 2008   (final data collection date for primary outcome measure)

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.

Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00275821
CRFB002A2302
Not Provided
External Affairs, Novartis
Novartis
Not Provided
Study Chair: Novartis Novartis - Including Sites in Germany
Novartis
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP