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:

Genetics Home Reference related topics: age-related macular degeneration

MedlinePlus related topics: Macular Degeneration

Genetic and Rare Diseases Information Center resources: Uveal Diseases

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided

More Information


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 Anecortave Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents

ClinicalTrials.gov processed this record on September 23, 2016

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