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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00051129
First received: January 3, 2003
Last updated: November 27, 2012
Last verified: August 2008
History of Changes
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean change from baseline in logMAR visual acuity score at 12 months [ Time Frame: Month 12 ] [ Designated as safety issue: No ]

Enrollment: 291
Study Start Date: January 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00051129     History of Changes
Other Study ID Numbers: C-02-27
Study First Received: January 3, 2003
Last Updated: November 27, 2012
Health Authority: United States: Food and Drug Administration

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:
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 June 18, 2013