Clinical trial NCT00454389: A Study of Strontium90 Beta Radiation With Lucentis to Treat Age-Related Macular Degeneration
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Macular Degeneration
Keywords: Macular
Degeneration
AMD
Wet Age-Related macular degeneration
Lead sponsor: NeoVista
Sponsor class: INDUSTRY
First posted: 2007-03-30
Enrollment: 494
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 12 months
Secondary outcomes:
measure: No loss in ETDRS letters
timeFrame: 12 months
measure: Change in total lesion size and CNV size by fluorescein angiography
timeFrame: 12 months
measure: Number of rescue injections of Lucentis.
timeFrame: 12 months
measure: Mean change in ETDRS visual acuity
timeFrame: 12 months
measure: Incidence and severity of adverse events and ocular adverse events. Incidence of cataract changes. Incidents of radiation induced toxicity.
timeFrame: 3 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Retinal Consultants of Arizona
state: Arizona
city: Tucson
country: United States
facility: Retina Center, PC
state: Arizona
city: Beverly Hills
country: United States
facility: Retina-Vitreous Associates Medical
state: California
city: Campbell
country: United States
facility: Retinal Diagnostic Center
state: California
city: Mountain View
country: United States
facility: Northern California Retina Vitreous Associates
state: California
city: San Francisco
country: United States
facility: UCSF Koret Vision Center
state: California
city: Ft. Lauderdale
country: United States
facility: Retina Group of Florida
state: Florida
city: Augusta
country: United States
facility: Southeast Retina Center
state: Georgia
city: Honolulu
country: United States
facility: Retina Institute of Hawaii
state: Hawaii
city: Paducah
country: United States
facility: Paducah Retinal Center
state: Kentucky
city: Boston
country: United States
facility: New England Eye Center-Tufts University
state: Massachusetts
city: Royal Oak
country: United States
facility: Associated Retinal Consultants / William Beaumont Hospital
state: Michigan
city: Kansas City
country: United States
facility: Eye Foundation of Kansas City
state: Missouri
city: Charlotte
country: United States
facility: Charlotte Eye Ear Nose & Throat Associates
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute
state: Ohio
city: Philadelphia
country: United States
facility: Retina Research Unit of Wills Eye Hospital
state: Pennsylvania
city: Nashville
country: United States
facility: Tennessee Retina
state: Tennessee
city: Austin
country: United States
facility: Austin Retina Associates
state: Texas
city: Austin
country: United States
facility: Retina Research Center
state: Texas
city: San Antonio
country: United States
facility: Medical Center Ophthalmology Associates
state: Texas
city: San Antonio
country: United States
facility: Retina & Uveitis Consultants of Texas
state: Texas
city: Salt Lake City
country: United States
facility: Rocky Mountain Retina Consultants
state: Utah
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Graz
country: Austria
facility: Augenklinik Graz
city: Leipzig
country: Germany
facility: Klinik und Poliklinik für Augenheilkunde der Universität Leipzig AöR
city: Würzburg
country: Germany
facility: Universitätsklinik und polyklinik für Augenkranke
city: Belfast
country: Ireland
facility: Institute of Clinical Science, Ophthalmic Research Centre, Royal Victoria Hospital
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
city: Lima
country: Peru
facility: Oftalmo Salud Eye Institute
city: Barcelona
country: Spain
facility: Institutio de Microcirugia Ocular-Barcelona
city: Geneva
country: Switzerland
facility: University of Geneva
city: London
country: United Kingdom
facility: Kings College Hospital
Study officials:
affiliation: Retinal Consultants of Arizona
name: Pravin Dugel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: NeoVista, Inc.
name: Jeffrey A Nau, MMS
role: STUDY_DIRECTOR
References:
citation: Evans JR, Igwe C, Jackson TL, Chong V. Radiotherapy for neovascular age-related macular degeneration. Cochrane Database Syst Rev. 2020 Aug 26;8(8):CD004004. doi: 10.1002/14651858.CD004004.pub4.