Age Related Macular Degeneration with Retino-choroidal Anastomosis
Conditions
Interventions
Product Name: RETAANE
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Anecortave
CAS Number: 7753-60-8
Current Sponsor code: AL-JVC-05-01
Other descriptive name: Anecortave Acetate
Sponsors
University Hospitals Leuven
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Belgium
Outcome results
None listed