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Radiation
A for Age-Related Macular Degeneration (CABERNET Trial)
Phase 3
Waitlist Available
Led By Pravin Dugel, MD
Research Sponsored by NeoVista
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
CABERNET Trial Summary
The objective of the CABERNET Trial is to evaluate the safety and efficacy of focal delivery of radiation for the treatment of subfoveal choroidal neovascularization (CNV) associated with wet age-related macular degeneration (AMD). The Epi-Rad90™ Ophthalmic System treats neovascularization of retinal tissue by means of a focal, directional delivery of radiation to the target tissues in the retina. Using standard vitreoretinal surgical techniques, the sealed radiation source is placed temporarily over the retinal lesion by means of a handheld medical device.
CABERNET Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of subjects losing fewer than 15 letters of best corrected visual acuity score at 12 months compared to baseline. Gain of 15 more letters of best correct visual acuity score compared to baseline
Secondary outcome measures
Change in total lesion size and CNV size by fluorescein angiography
Incidence and severity of adverse events and ocular adverse events. Incidence of cataract changes. Incidents of radiation induced toxicity.
Mean change in ETDRS visual acuity
+2 moreCABERNET Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: AExperimental Treatment1 Intervention
Epi-Rad90™ Ophthalmic System procedure + Lucentis
Group II: BActive Control1 Intervention
Lucentis only
Find a Location
Who is running the clinical trial?
NeoVistaLead Sponsor
2 Previous Clinical Trials
52 Total Patients Enrolled
Pravin Dugel, MDPrincipal InvestigatorRetinal Consultants of Arizona
1 Previous Clinical Trials
185 Total Patients Enrolled
Jeffrey A Nau, MMSStudy DirectorNeoVista, Inc.
1 Previous Clinical Trials
20 Total Patients Enrolled
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