Trial | NCT00454389  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    ranibizumab ...

  • Study Participants

    494
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.
Therapeutic advances in the arena of neovascular age-related macular degeneration (AMD) have provided multiple treatment options for the disease. Radiotherapy has been studied in multiple clinical trials in the past with many studies showing a therapeutic benefit. Treatment with radiotherapy and anti-VEGF compounds is a promising approach to treating AMD.
Study Started
Apr 30
2007
Primary Completion
Sep 30
2011
Anticipated
Study Completion
Aug 31
2012
Anticipated
Last Update
Jul 27
2011
Estimate

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

  • Other names: Lucentis

A Experimental

Epi-Rad90™ Ophthalmic System procedure + Lucentis

B Active Comparator

Lucentis only

Criteria 

Inclusion Criteria:

Subjects must have predominantly classic, minimally classic, or occult with no classic lesions, as determined by the Investigator, secondary to AMD, with a total lesion size (including blood, scarring, and neovascularization) of < 12 total disc areas (21.24 mm2), and a GLD ≤5.4 mm
Subjects must be age 50 or older

Exclusion Criteria:

Subjects with prior or concurrent subfoveal CNV therapy including thermal laser photocoagulation (with or without photographic evidence), photodynamic therapy, injections with Macugen®, intravitreal or subretinal steroids, transpupillary thermotherapy (TTT), and systemic anti-angiogenic or intravitreal anti-angiogenic agents in study eye. (Note: This includes subjects with no known history, but with photographic evidence of prior therapy)
Subjects who underwent previous radiation therapy to the eye, head or neck
Subjects that have been previously diagnosed or have retinal findings consistent with Type 1 or Type 2 Diabetes Mellitus
No Results Posted