Anecortave Acetate Safety in Patients With Open-Angle Glaucoma or Ocular Hypertension

Alcon

Status and phase: Completed; Phase 3; Phase 2

Conditions: Open-angle Glaucoma; Oular Hypertension

Treatments: Drug: Anecortave Acetate Sterile Suspension, 60 mg/mL; Drug: Anecortave Acetate Sterile Suspension, 30 mg/mL; Drug: Anecortave Acetate Sterile Suspension, 75 mg/mL; Other: Anecortave Acetate Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT00691717

C-07-36

Details and patient eligibility

About

The purpose of this study was to evaluate the safety and intraocular-lowering efficacy of anecortave acetate depot when administered by anterior juxtascleral depot (AJD) for the treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Enrollment: 201 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients 18 years of age or older with open-angle glaucoma (with or without pigment dispersion or pseudoexfoliation) or ocular hypertension.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Patients with any form of glaucoma other than open-angle.
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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201 participants in 4 patient groups, including a placebo group

24 mg Anecortave Acetate

Experimental group

Description:

Anecortave Acetate Sterile Suspension, 30 mg/mL, single depot administration of 0.8 mL in the study eye

Treatment:

Drug: Anecortave Acetate Sterile Suspension, 30 mg/mL

48 mg Anecortave Acetate

Experimental group

Description:

Anecortave Acetate Sterile Suspension, 60 mg/mL, single depot administration of 0.8 mL in the study eye

Treatment:

Drug: Anecortave Acetate Sterile Suspension, 60 mg/mL

60 mg Anecortave Acetate

Experimental group

Description:

Anecortave Acetate Sterile Suspension, 75 mg/mL, single depot administration of 0.8 mL in the study eye

Treatment:

Drug: Anecortave Acetate Sterile Suspension, 75 mg/mL

Anecortave Acetate Vehicle

Placebo Comparator group

Description:

Single depot administration of 0.8 mL in the study eye

Treatment:

Other: Anecortave Acetate Vehicle