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An Evaluation of Efficacy and Safety of Posterior Juxtascleral Injections of Anecortave Acetate 15mg (0.5mL of 30mg/mL Anecortave Acetate Sterile Suspension) Versus Visudyne in Patient with Subfoveal Exudative Age-Related Macular Degeneration (AMD) Eligible for Initial Treatment with Photodynamic Therapy (PDT) Using Visudyne®

Principal Investigator

Richard Rosen, M.D.

Enrollment Status  

Completed   

Objective

To demonstrate that Anecortave Acetate 15mg (0.5mL of 30mg/mL Anecortave Acetate Sterile Suspension) is non-inferior after 12 months of treatment to Photodynamic Therapy (PDT) with Visudyne® in patients eligible for initial PDT treatment.

Eligibility

Patients of either gender, with diagnosis of Exudative AMD and a primary or recurrent "classic" subfoveal CNV lesion in the study eye. Visual acuity of 20/40 to 20/400 in the study eye.

Study Results

Five hundred thirty patients with predominantly classic subfoveal choroidal neovascularization secondary to age-related macular degeneration were randomized to treatment with either anecortave acetate 15 mg or PDT.  Percent responders in the anecortave acetate and PDT groups were 45% and 49%, respectively (not statistically different, P = 0.43). The confidence interval (CI) for the difference ranged from -13.2% favoring PDT to +5.6% favoring anecortave acetate. The month 12 clinical outcome for anecortave acetate was improved in patients for whom reflux was controlled and who were treated within the 6-month treatment window (57% vs. 49%; 95% CI, -4.3% favoring PDT to +21.7% favoring anecortave acetate). No serious adverse events related to the study drug were reported in either treatment group.

Conclusions

The safety and efficacy outcomes in this study demonstrate that the benefits of anecortave acetate for the treatment of choroidal neovascularization outweigh the risks associated with either the drug or the periocular posterior juxtascleral depot (PJD) administration procedure.

For more information: ClinicalTrials.gov

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