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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

Study Description
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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).

Condition or disease Intervention/treatment Phase
Macular Degeneration Maculopathy, Age-Related Age-Related Maculopathies Age-Related Maculopathy Maculopathies, Age-Related Drug: Anecortave Acetate 15 mg sterile suspension Other: Anecortave Acetate Vehicle Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 291 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: An Evaluation of Safety and Efficacy of Anecortave Acetate Versus Placebo in Patients With Subfoveal Choroidal Neovascularization Due to Exudative Age-Related Macular Degeneration.
Study Start Date : January 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Anecortave Acetate
Posterior juxtascleral injection in the study eye at 6 month intervals (Day 0, Month 6, Month 12, Month 18)
 Drug: Anecortave Acetate 15 mg sterile suspension
0.5 ml of 30 mg/ml administered as a posterior juxtascleral injection
Placebo Comparator: Anecortave Acetate Vehicle
Posterior juxtascleral injection in the study eye at 6 month intervals (Day 0, Month 6, Month 12, Month 18)
 Other: Anecortave Acetate Vehicle
Administered as a posterior juxtascleral injection


Outcome Measures
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Primary Outcome Measures :
  1. Mean change from baseline in logMAR visual acuity score at 12 months [ Time Frame: Month 12 ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00051129    
Other Study ID Numbers: C-02-27
First Posted: January 7, 2003    Key Record Dates
Last Update Posted: November 28, 2012
Last Verified: August 2008
Keywords provided by Alcon Research:
AMD
anecortave acetate
wet AMD
age-related macular degeneration
Macular Degeneration
 Maculopathy, Age-Related
Age-Related Maculopathies
Age-Related Maculopathy
Maculopathies, Age-Related
Additional relevant MeSH terms:
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Macular Degeneration
Choroidal Neovascularization
Neovascularization, Pathologic
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases
 Hydrocortisone
Anecortave
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Anti-Inflammatory Agents