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
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Sponsor:
Alcon Research
Information provided by (Responsible Party):
Alcon Research
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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 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 |
Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics:
Age-related macular degeneration
MedlinePlus related topics:
Macular Degeneration
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)
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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)
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Other: Anecortave Acetate Vehicle
Administered as a posterior juxtascleral injection |
Primary Outcome Measures :
- Mean change from baseline in logMAR visual acuity score at 12 months [ Time Frame: Month 12 ]
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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.
No Contacts or Locations Provided
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:
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 |