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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:
Alcon Research
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
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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 Intervention Model: Parallel Assignment Masking: Double Blind (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. |
Resource links provided by NLM:
Genetics Home Reference related topics:
age-related macular degeneration
MedlinePlus related topics:
Macular Degeneration
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 ]
| 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) |
| 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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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 |
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 Hydrocortisone Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on July 21, 2017