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Anecortave Acetate in Subfoveal Choroidal Neovascularization (CNV) Due to Wet Age-Related Macular Degeneration (AMD)

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ClinicalTrials.gov Identifier: NCT00051129
Recruitment Status : Completed
First Posted : January 7, 2003
Last Update Posted : November 28, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Tracking Information
First Submitted Date  ICMJE January 3, 2003
First Posted Date  ICMJE January 7, 2003
Last Update Posted Date November 28, 2012
Study Start Date  ICMJE January 2007
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 27, 2012)
Mean change from baseline in logMAR visual acuity score at 12 months [ Time Frame: Month 12 ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anecortave Acetate in Subfoveal Choroidal Neovascularization (CNV) Due to Wet Age-Related Macular Degeneration (AMD)
Official Title  ICMJE An Evaluation of Safety and Efficacy of Anecortave Acetate Versus Placebo in Patients With Subfoveal Choroidal Neovascularization Due to Exudative Age-Related Macular Degeneration.
Brief Summary The purpose of this study was to evaluate anecortave acetate compared to placebo for maintenance of visual acuity after 24 months of treatment in patients with subfovial choroidal neovascularization (CNV) due to exudative age-related macular degeneration (AMD).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Macular Degeneration
  • Maculopathy, Age-Related
  • Age-Related Maculopathies
  • Age-Related Maculopathy
  • Maculopathies, Age-Related
Intervention  ICMJE
  • Drug: Anecortave Acetate 15 mg sterile suspension
    0.5 ml of 30 mg/ml administered as a posterior juxtascleral injection
  • Other: Anecortave Acetate Vehicle
    Administered as a posterior juxtascleral injection
Study Arms  ICMJE
  • Experimental: Anecortave Acetate
    Posterior juxtascleral injection in the study eye at 6 month intervals (Day 0, Month 6, Month 12, Month 18)
    Intervention: Drug: Anecortave Acetate 15 mg sterile suspension
  • Placebo Comparator: Anecortave Acetate Vehicle
    Posterior juxtascleral injection in the study eye at 6 month intervals (Day 0, Month 6, Month 12, Month 18)
    Intervention: Other: Anecortave Acetate Vehicle
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 29, 2012)
291
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 2008
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of exudative AMD and a primary or recurrent subfoveal CNV lesion in the study eye.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Under 50 years.
  • Other protocol-defined exclusion criteria may apply.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00051129
Other Study ID Numbers  ICMJE C-02-27
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alcon Research
Study Sponsor  ICMJE Alcon Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Alcon Research
Verification Date August 2008

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