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

Study Overview
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Brief Summary
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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.

Official Title
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A Study of the Safety and IOP-Lowering Efficacy of Anecortave Acetate in Patients With Open-Angle Glaucoma or Ocular Hypertension

Conditions
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Open-angle Glaucoma, Oular Hypertension

Intervention / Treatment
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* Drug: Anecortave Acetate Sterile Suspension, 30 mg/mL
* Drug: Anecortave Acetate Sterile Suspension, 60 mg/mL
* Drug: Anecortave Acetate Sterile Suspension, 75 mg/mL
* Other: Anecortave Acetate Vehicle


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 24 mg Anecortave Acetate<br>Anecortave Acetate Sterile Suspension, 30 mg/mL, single depot administration of 0.8 mL in the study eye | Drug: Anecortave Acetate Sterile Suspension, 30 mg/mL<br>* Single administration by anterior juxtascleral depot<br>|
| Experimental: 48 mg Anecortave Acetate<br>Anecortave Acetate Sterile Suspension, 60 mg/mL, single depot administration of 0.8 mL in the study eye | Drug: Anecortave Acetate Sterile Suspension, 60 mg/mL<br>* Single administration by anterior juxtascleral depot<br>|
| Experimental: 60 mg Anecortave Acetate<br>Anecortave Acetate Sterile Suspension, 75 mg/mL, single depot administration of 0.8 mL in the study eye | Drug: Anecortave Acetate Sterile Suspension, 75 mg/mL<br>* Single administration by anterior juxtascleral depot<br>|
| Placebo Comparator: Anecortave Acetate Vehicle<br>Single depot administration of 0.8 mL in the study eye | Other: Anecortave Acetate Vehicle<br>* Single administration by anterior juxtascleral depot<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Intraocular Pressure at 8 am |  | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Patients Who Remained Rescue Medication-Free at Month 3 (8 am) |  | Month 3, 8 am | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anecortave acetate, Open-angle glaucoma, IOP, OHT