An Open Label Evaluation of Efficacy and Safety of Posterior Juxtascleral Administrations of 15 mg Anecortave Acetate for Depot Suspension Combined with Verteporfin Therapy in Patients with Exudative Age-related Macular Degeneration and Retino-choroidal Anastomosis.

• Conditions: Age Related Macular Degeneration with Retino-choroidal Anastomosis

• Registration Number: EUCTR2005-002912-73-BE
• Lead Sponsor: niversity Hospitals Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08-22
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Clinical diagnosis of exudative AMD compicated with retino-choroidal anastomosis in the study eye (eye to be treated).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Use of any investigational drug or treatment related or unrelated to ARMD.
Patient on intravenous or subcutaneous anticoagulant therapy.
Patient with a clinically relevant medical condition or ophthalmic disease that may preclude safe participation in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the improvement of efficacy by adding Anecortave Acetate 15mg (0,5mL of 30 mg/ml Anecortave Acetate sterile suspension) to the standard photodynamic treatment with Visudyne (Novartis) of patients with age-related macular degeneration and retino-choroidal anastomosis.;Secondary Objective: To investigate the safety of combining Anecortave Acetate 15mg (0,5mL of 30 mg/ml Anecortave Acetate sterile suspension) with the standard photodynamic treatment with Visudyne (Novartis) in patients with age-related macular degeneration and retino-choroidal anastomosis.;Primary end point(s): The primary efficacy parameters will be the percentage of patients who maintain a positive visual acuity outcome (<3-line loss of logMAR VA), and mean change from baseline in logMAR visual acuity score.