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

Alcon

Status and phase: Completed; Phase 3

Conditions: Macular Degeneration; Age-Related Maculopathy; Age-Related Maculopathies; Maculopathy, Age-Related; Maculopathies, Age-Related

Treatments: Drug: Anecortave Acetate 15 mg sterile suspension; Other: Anecortave Acetate Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT00051129

C-02-27

Details and patient eligibility

About

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).

Enrollment: 291 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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291 participants in 2 patient groups, including a placebo group

Anecortave Acetate

Experimental group

Description:

Posterior juxtascleral injection in the study eye at 6 month intervals (Day 0, Month 6, Month 12, Month 18)

Treatment:

Drug: Anecortave Acetate 15 mg sterile suspension

Anecortave Acetate Vehicle

Placebo Comparator group

Description:

Posterior juxtascleral injection in the study eye at 6 month intervals (Day 0, Month 6, Month 12, Month 18)

Treatment:

Other: Anecortave Acetate Vehicle