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A Study of Strontium90 Beta Radiation With Lucentis to Treat Age-Related Macular Degeneration

NCT00454389 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 494

Last updated 2011-07-27

No results posted yet for this study

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.

Conditions

  • Macular Degeneration

Interventions

DEVICE

Epi-Rad90™ Ophthalmic System

A single procedure using the Epi-Rad90™ Ophthalmic System plus 2 injections of Lucentis administered 1 month apart

DRUG

ranibizumab

Lucentis injection administered monthly for the first 3 injections followed by quarterly injections

Sponsors & Collaborators

  • NeoVista

    lead INDUSTRY

Principal Investigators

  • Pravin Dugel, MD · Retinal Consultants of Arizona

  • Jeffrey A Nau, MMS · NeoVista, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2011-09-30
Completion
2012-08-31

Countries

  • United States
  • Austria
  • Germany
  • Ireland
  • Israel
  • Peru
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00454389 on ClinicalTrials.gov