A Study of Strontium90 Beta Radiation With Lucentis to Treat Age-Related Macular Degeneration
- Conditions
- Macular Degeneration
- Interventions
- Device: Epi-Rad90™ Ophthalmic System
- Registration Number
- NCT00454389
- Lead Sponsor
- NeoVista
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 494
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Epi-Rad90™ Ophthalmic System Epi-Rad90™ Ophthalmic System procedure + Lucentis B ranibizumab Lucentis only
- Primary Outcome Measures
Name Time Method 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 12 months
- Secondary Outcome Measures
Name Time Method Change in total lesion size and CNV size by fluorescein angiography 12 months Number of rescue injections of Lucentis. 12 months Mean change in ETDRS visual acuity 12 months Incidence and severity of adverse events and ocular adverse events. Incidence of cataract changes. Incidents of radiation induced toxicity. 3 years No loss in ETDRS letters 12 months
Trial Locations
- Locations (32)
Retinal Consultants of Arizona
🇺🇸Phoenix, Arizona, United States
Retina Center, PC
🇺🇸Tucson, Arizona, United States
Retina-Vitreous Associates Medical
🇺🇸Beverly Hills, California, United States
Retinal Diagnostic Center
🇺🇸Campbell, California, United States
Northern California Retina Vitreous Associates
🇺🇸Mountain View, California, United States
UCSF Koret Vision Center
🇺🇸San Francisco, California, United States
Retina Group of Florida
🇺🇸Ft. Lauderdale, Florida, United States
Southeast Retina Center
🇺🇸Augusta, Georgia, United States
Retina Institute of Hawaii
🇺🇸Honolulu, Hawaii, United States
Paducah Retinal Center
🇺🇸Paducah, Kentucky, United States
Scroll for more (22 remaining)Retinal Consultants of Arizona🇺🇸Phoenix, Arizona, United States