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

eo Vista Inc.0 个研究点目标入组 467 人开始时间: 2010年6月30日最近更新: 2012年3月19日

试验速览

暂无简介。

•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
•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

•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

发起方

eo Vista Inc.