Anecortave Acetate for Treatment of Steroid Induced Intraocular Pressure (IOP) Elevation

Alcon

Status and phase: Completed; Phase 2

Conditions: Eye Diseases

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00315640

C-05-03

2005-001598-93

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of anecortave acetate depot when administered for the treatment of elevated IOP following treatment with steroids.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Either gender
• 18 years of age or older
• IOP elevation caused by steroid usage
• Other protocol-defined inclusion criteria may apply

Exclusion criteria

• Under 18 years of age
• 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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70 participants in 4 patient groups

Anecortave Acetate 3 mg Depot

Experimental group

Description:

One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye

Treatment:

Drug: Anecortave Acetate Sterile Suspension, 6 mg/mL

Anecortave Acetate 15 mg Depot

Experimental group

Description:

One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye

Treatment:

Drug: Anecortave Acetate Suspension Depot, 30 mg/mL

Anecortave Acetate 30 mg Depot

Experimental group

Description:

One 0.5 mL anterior juxtascleral depot (AJD) injection in the study eye

Treatment:

Drug: Anecortave Acetate Sterile Suspension, 60 mg/mL

Anecortave Acetate Vehicle

Other group

Treatment:

Other: Anecortave Acetate Vehicle