A Dose-Volume Study of a Treatment for Elevated IOP Due to 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 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.

Official Title
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A Dose-Volume 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, Ocular Hypertension

Intervention / Treatment
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* Drug: Anecortave Acetate Sterile Suspension, 6 mg/mL
* Drug: Anecortave Acetate Sterile Suspension, 3.75 mg/mL
* Drug: Anecortave Acetate Sterile Suspension, 96 mg/mL
* Drug: Anecortave Acetate Sterile Suspension, 60 mg/ML
* Other: Anecortave Acetate Vehicle


Participation Criteria
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Eligibility Criteria
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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.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3 mg Anecortave Acetate, low volume high dose<br>Anecortave Acetate Sterile Suspension, 6 mg/mL, one injection of 0.5 mL in the study eye monthly for 6 months. | Drug: Anecortave Acetate Sterile Suspension, 6 mg/mL<br>* Administered as an injection into an anterior juxtascleral depot<br>|
| Experimental: 3 mg Anecortave Acetate, high volume low dose<br>Anecortave Acetate Sterile Suspension, 3.75 mg/mL, one injection of 0.8 mL in the study eye monthly for 6 months. | Drug: Anecortave Acetate Sterile Suspension, 3.75 mg/mL<br>* Administered as an injection into an anterior juxtascleral depot<br>|
| Experimental: 48 mg Anecortave Acetate, low volume high dose<br>Anecortave Acetate Sterile Suspension, 96 mg/mL, one injection of 0.5 mL in the study eye monthly for 6 months. | Drug: Anecortave Acetate Sterile Suspension, 96 mg/mL<br>* Administered as an injection into an anterior juxtascleral depot<br>|
| Experimental: 48 mg Anecortave Acetate, high volume low dose<br>Anecortave Acetate Sterile Suspension, 60 mg/mL, one injection of 0.8 mL in the study eye monthly for 6 months. | Drug: Anecortave Acetate Sterile Suspension, 60 mg/ML<br>* Administered as an injection into an anterior juxtascleral depot<br>|
| Placebo Comparator: Anecortave Acetate Vehicle, low volume<br>Anecortave Acetate Vehicle, one injection of 0.5 mL in the study eye monthly for 6 months. | Other: Anecortave Acetate Vehicle<br>* Administered as an injection into an anterior juxtascleral depot<br>|
| Placebo Comparator: Anecortave Acetate Vehicle, high volume<br>Anecortave Acetate Vehicle, one injection of 0.8 mL in the study eye monthly for 6 months. | Other: Anecortave Acetate Vehicle<br>* Administered as an injection into an 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 |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of patients who remain rescue-medication free |  | 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Open-Angle Glaucoma, Intraocular Pressure, Anecortave Acetate