A Dose-Volume Study of a Treatment for Elevated IOP Due to Open-Angle Glaucoma or Ocular Hypertension

Alcon

Status and phase: Terminated; Phase 2

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Treatments: Drug: Anecortave Acetate Sterile Suspension, 60 mg/ML; Other: Anecortave Acetate Vehicle; Drug: Anecortave Acetate Sterile Suspension, 3.75 mg/mL; Drug: Anecortave Acetate Sterile Suspension, 96 mg/mL; Drug: Anecortave Acetate Sterile Suspension, 6 mg/mL

Study type: Interventional

Funder types: Industry

Identifiers

NCT00788541

C-08-049

Details and patient eligibility

About

The purpose of this study was to assess the effects of total volume and total dose on the safety and intraocular pressure-lowering efficacy of Anecortave Acetate Suspension (3 mg and 48 mg) in 0.5 mL and 0.8 mL volumes 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: 197 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of Open-Angle Glaucoma or Ocular Hypertension for at least 6 months;
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Prior angle surgery in the study eye, severe visual field loss in either eye;
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

197 participants in 6 patient groups, including a placebo group

3 mg Anecortave Acetate, low volume high dose

Experimental group

Description:

Anecortave Acetate Sterile Suspension, 6 mg/mL, one injection of 0.5 mL in the study eye monthly for 6 months.

Treatment:

Drug: Anecortave Acetate Sterile Suspension, 6 mg/mL

3 mg Anecortave Acetate, high volume low dose

Experimental group

Description:

Anecortave Acetate Sterile Suspension, 3.75 mg/mL, one injection of 0.8 mL in the study eye monthly for 6 months.

Treatment:

Drug: Anecortave Acetate Sterile Suspension, 3.75 mg/mL

48 mg Anecortave Acetate, low volume high dose

Experimental group

Description:

Anecortave Acetate Sterile Suspension, 96 mg/mL, one injection of 0.5 mL in the study eye monthly for 6 months.

Treatment:

Drug: Anecortave Acetate Sterile Suspension, 96 mg/mL

48 mg Anecortave Acetate, high volume low dose

Experimental group

Description:

Anecortave Acetate Sterile Suspension, 60 mg/mL, one injection of 0.8 mL in the study eye monthly for 6 months.

Treatment:

Drug: Anecortave Acetate Sterile Suspension, 60 mg/ML

Anecortave Acetate Vehicle, low volume

Placebo Comparator group

Description:

Anecortave Acetate Vehicle, one injection of 0.5 mL in the study eye monthly for 6 months.

Treatment:

Other: Anecortave Acetate Vehicle

Anecortave Acetate Vehicle, high volume

Placebo Comparator group

Description:

Anecortave Acetate Vehicle, one injection of 0.8 mL in the study eye monthly for 6 months.

Treatment:

Other: Anecortave Acetate Vehicle