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

Alcon

Status and phase: Completed; Phase 3

Conditions: Macular Degeneration

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00299507

C-04-59

Details and patient eligibility

About

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).

Enrollment: 240 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 4 patient groups

15 mg Anecortave Acetate, 3 month intervals

Experimental group

Description:

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).

Treatment:

Drug: Anecortave Acetate Sterile Suspension, 30 mg/mL

15 mg Anecortave Acetate, 6 month intervals

Experimental group

Description:

Anecortave Acetate Sterile Suspension, 30 mg/mL, one 0.5 mL posterior juxtascleral depot injection at 6 month intervals (3, 9, 15, 21 months).

Treatment:

Drug: Anecortave Acetate Sterile Suspension, 30 mg/mL

30 mg Anecortave Acetate, 6 month intervals

Experimental group

Description:

Anecortave Acetate Sterile Suspension, 60 mg/mL, one 0.5 mL posterior juxtascleral depot injection at 6 month intervals (3, 9, 15, 21 months).

Treatment:

Drug: Anecortave Acetate Sterile Suspension, 60 mg/mL

Anecortave Acetate Vehicle

Sham Comparator group

Description:

One 0.5 mL sham injection of Anecortave Acetate Vehicle at 6 month intervals (3, 9, 15, 21 months).

Treatment:

Other: Anecortave Acetate Vehicle