non-exudative age related macular degeneration (dry AMD)
Conditions
Sponsors
Alcon Research Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients over 50 years of age with a clinical diagnosis of exudative AMD in one eye (non-study eye) and the presence of the following characteristics in the second eye (study eye, eye to be treated): At least 5 or more intermediate (>63 microns) or larger soft drusen AND/OR Confluent drusen within 3000 microns of the foveal center AND Hyperpigmentation Best-corrected ETDRS logMAR visual acuity of 0.50 (equivalent to 20/62.5 Snellen) or better in the study eye 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: Current or history of medical condition that would preclude scheduled study visits or completion of the study. Current or history of ophthalmic disease in the study eye (other than AMD) that would likely compromise or during follow-up could likely compromise the visual acuity of the study eye. Clinical signs of myopic retinopathy, or refraction of > –8 diopter power. Intraocular surgery in study eye (eye to be treated) within 60 days prior to enrolling in the study. Insertion of a scleral buckle in the study eye (eye to be treated). Clinical evidence of geographic atrophy (hypopigmentation = 125 microns) in the second eye (eye to be treated). Evidence of past or present CNV in the study eye. Investigational or approved therapy of any kind for AMD in the study eye. Intravenous or subcutaneous anticoagulant therapy, or oral anticoagulant therapy (with the exception of aspirin and antiplatelet therapy) and cannot take a 5-day interruption in therapy prior to each depot or sham administration procedure. Clinical evidence of scleral thinning
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to demonstrate that Anecortave Acetate for Depot Suspension (15 mg or 30 mg) is safe and effective in arresting the progression of non-exudative (dry) AMD in patients who are at-risk for progressing to exudative (wet) AMD. ;Secondary Objective: The secondary efficacy parameter will be the time to development of sight-threatening CNV and the percentage of patients with <3 ETDRS line visual acuity loss. from baseline.;Primary end point(s): The primary statistical objective of this study is to demonstrate that Anecortave Acetate (15 mg or 30 mg) is superior to placebo as demonstrated by a lower incidence of sight-threatening CNV. Patients enrolled in this study will have evidence of wet AMD in one eye (the non-study eye) and dry AMD in the fellow eye (the study eye) that is at risk for progressing to wet AMD. The study eye will be randomized to treatment in this trial. The primary efficacy parameter will be the percentage of patients with sight-threatening CNV in the study eye at Month 48. | — |
Countries
Denmark, Spain
Outcome results
None listed