A Randomized, Prospective, Active Controlled, Study of the Epi-Rad90™ Ophthalmic System for the Treatment of Subfoveal Choroidal Neovascularization Associated with Wet Age-Related Macular Degeneration- CABERNET - CNV Secondary to AMD Treated with BEta RadiatioN Epiretinal Therapy

• Conditions: choroidal neovascularization (CNV) associated with wet age-related macular degeneration (AMD).

• Registration Number: EUCTR2007-005798-75-GB
• Lead Sponsor: eo Vista Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-30
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 467

Inclusion Criteria

Subjects must be age 50 or older;
Best Corrected VA 20/40 to 20/320 Snellen
All Lesion Subtypes: Predominantly Classic, Minimally Classic, or Occult
Lesions MUST be Active.
Subretinal Hemorrhage less than 50% of total lesion size & not in subfoveal space;
Minimally Classic and Occult Lesions must have evidence of recent disease progression defined as:
Presence of Subretinal Hemorrhage and/or Fluid and/or Lipid OR
Loss of 1 or more lines of Vision / past 6 months
OR
FA documented lesion growth by = 10% / past 6 months;
Women Post-Menopausal =1 year or Surgically Sterilized
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

Subjects with prior AMD Treatment
Subjects with Concomitant Disease in the Study Eye (Uveitis, DR, ocular infections, etc.)
Subjects with Glaucoma (IOP = 30 mmHg)
Subjects with Retinal Vasculopathies – RVO, Diabetic Retinopathy
Subjects with any subfoveal scarring, atrophy, or hemorrhage
CNV lesion has significant scarring and/or atrophy;
Diagnosed Diabetes Mellitus;
Previous Intra-ocular surgery, excluding cataract surgery

Study & Design

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