Anecortave Acetate in Patients With Exudative Age-related Macular Degeneration (AMD)

Study Overview
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Brief Summary
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The purpose of this study was to evaluate the effect of the dose concentration and administration frequency of Anecortave Acetate (AA) on visual acuity (VA) and lesion size when administered by posterior juxtascleral depot (PJD) every 3 months (AA 15 mg) or 6 months (AA 15 mg, AA 30 mg) in patients with exudative age-related macular degeneration (AMD).

Official Title
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Anecortave Acetate 15 mg Administered Every 3 Months Versus Anecortave Acetate 15 mg Administered Every 6 Months Versus Anecortave Acetate 30 mg Administered Every 6 Months in Patients With Exudative Age-Related Macular Degeneration (AMD)

Conditions
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Macular Degeneration

Intervention / Treatment
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* Drug: Anecortave Acetate Sterile Suspension, 30 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 exudative AMD and a primary or recurrent (after laser photocoagulation) subfoveal choroidal neovascularization (CNV) lesion. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Less than 50 years of age. Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 50 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 15 mg Anecortave Acetate, 3 month intervals<br>Anecortave Acetate Sterile Suspension, 30 mg/mL, one 0.5 mL posterior juxtascleral depot injection at 3 month intervals (0, 3, 6, 9, 12, 15, 18 months). | Drug: Anecortave Acetate Sterile Suspension, 30 mg/mL<br>* One 0.5 mL posterior juxtascleral depot injection at 3 or 6 month intervals<br>|
| Experimental: 15 mg Anecortave Acetate, 6 month intervals<br>Anecortave Acetate Sterile Suspension, 30 mg/mL, one 0.5 mL posterior juxtascleral depot injection at 6 month intervals (3, 9, 15, 21 months). | Drug: Anecortave Acetate Sterile Suspension, 30 mg/mL<br>* One 0.5 mL posterior juxtascleral depot injection at 3 or 6 month intervals<br>|
| Experimental: 30 mg Anecortave Acetate, 6 month intervals<br>Anecortave Acetate Sterile Suspension, 60 mg/mL, one 0.5 mL posterior juxtascleral depot injection at 6 month intervals (3, 9, 15, 21 months). | Drug: Anecortave Acetate Sterile Suspension, 60 mg/mL<br>* One 0.5 mL posterior juxtascleral depot injection at 6 month intervals<br>|
| Sham Comparator: Anecortave Acetate Vehicle<br>One 0.5 mL sham injection of Anecortave Acetate Vehicle at 6 month intervals (3, 9, 15, 21 months). | Other: Anecortave Acetate Vehicle<br>* One 0.5 mL sham injection at 6 month intervals<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in best-corrected visual acuity (BCVA) at Month 12 from baseline |  | Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in lesion growth at Month 12 from baseline |  | Month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exudative AMD, age-related macular degeneration (AMD)