A Phase II Study of Anecortave Acetate for the Treatment of Exudative Age-Related Macular Degeneration

Alcon

Status and phase: Completed; Phase 2

Conditions: AMD

Treatments: Drug: Anecortave Acetate 3 mg; Other: Anecortave Acetate Vehicle; Drug: Anecortave Acetate 15 mg; Drug: Anecortave acetate 30 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00346957

C-98-03

Details and patient eligibility

About

The purpose of the study is to determine the concentration of anecortave acetate (15 or 30 mg versus placebo) that is safe and effective for the inhibition of the growth of blood vessels in the retina in patients with wet AMD.

Enrollment: 128 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Ages 50 years and over
• Other protocol-defined inclusion and exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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128 participants in 4 patient groups, including a placebo group

Anecortave Acetate 30

Experimental group

Treatment:

Drug: Anecortave acetate 30 mg

Anecortave Acetate 15

Experimental group

Treatment:

Drug: Anecortave Acetate 15 mg

Anecortave Acetate 3

Experimental group

Treatment:

Drug: Anecortave Acetate 3 mg

Anecortave Acetate Vehicle

Placebo Comparator group

Treatment:

Other: Anecortave Acetate Vehicle