Anecortave Acetate in Patients With Open-angle Glaucoma

Alcon

Status and phase: Completed; Phase 2

Conditions: Open-angle Glaucoma

Treatments: Drug: Anecortave Acetate Sterile Suspension, 60 mg/mL; Other: Anecortave Acetate Vehicle; Drug: Anecortave Acetate Sterile Suspension, 6 mg/mL; Drug: Anecortave Acetate Sterile Suspension, 30 mg/mL

Study type: Interventional

Funder types: Industry

Identifiers

NCT00320203

C-04-62

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, efficacy, and duration of effect of a single administration of Anecortave Acetate Depot for treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma.

Enrollment: 86 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients 18 years of age or older with open-angle glaucoma.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Patients with open-angle glaucoma with a pseudoexfoliation or pigment dispersion component.
• 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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86 participants in 4 patient groups

Anecortave Acetate 3 mg Depot

Experimental group

Description:

Single injection, anterior juxtascleral depot (AJD)

Treatment:

Drug: Anecortave Acetate Sterile Suspension, 6 mg/mL

Anecortave Acetate 15 mg Depot

Experimental group

Description:

Single injection, anterior juxtascleral depot (AJD)

Treatment:

Drug: Anecortave Acetate Sterile Suspension, 30 mg/mL

Anecortave Acetate 30 mg Depot

Experimental group

Description:

Single injection, anterior juxtascleral depot (AJD)

Treatment:

Drug: Anecortave Acetate Sterile Suspension, 60 mg/mL

Anecortave Acetate Vehicle

Other group

Description:

Single injection, anterior juxtascleral depot (AJD)

Treatment:

Other: Anecortave Acetate Vehicle