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

Macular Degeneration Clinical Trial

— CABERNET  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00454389
• Other study ID #: NVI-114
• Status: Active, not recruiting
• Phase: Phase 3
• First received: March 28, 2007
• Last updated: July 26, 2011
• Start date: April 2007
• Est. completion date: August 2012

Study information

• Verified date: July 2011
• Source: NeoVista
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical DevicesAustria: Federal Ministry for Health and WomenSwitzerland: SwissmedicUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyBrazil: National Health Surveillance AgencySpain: Ministry of Health and ConsumptionIsrael: Ministry of HealthPeru: Ministry of Health
• Study type: Interventional

Clinical 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 494
• Est. completion date: August 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Macular Degeneration

Intervention

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

Locations

Country	Name	City	State
Austria	Augenklinik Graz	Graz
Germany	Klinik und Poliklinik für Augenheilkunde der Universität Leipzig AöR	Leipzig
Germany	Universitätsklinik und polyklinik für Augenkranke	Würzburg
Ireland	Institute of Clinical Science, Ophthalmic Research Centre, Royal Victoria Hospital	Belfast
Israel	Sourasky Medical Center	Tel Aviv
Peru	Oftalmo Salud Eye Institute	Lima
Spain	Institutio de Microcirugia Ocular-Barcelona	Barcelona
Switzerland	University of Geneva	Geneva
United Kingdom	Kings College Hospital	London
United States	Southeast Retina Center	Augusta	Georgia
United States	Austin Retina Associates	Austin	Texas
United States	Retina Research Center	Austin	Texas
United States	Retina-Vitreous Associates Medical	Beverly Hills	California
United States	New England Eye Center-Tufts University	Boston	Massachusetts
United States	Retinal Diagnostic Center	Campbell	California
United States	Charlotte Eye Ear Nose & Throat Associates	Charlotte	North Carolina
United States	Cincinnati Eye Institute	Cincinnati	Ohio
United States	Retina Group of Florida	Ft. Lauderdale	Florida
United States	Retina Institute of Hawaii	Honolulu	Hawaii
United States	Eye Foundation of Kansas City	Kansas City	Missouri
United States	University of Wisconsin	Madison	Wisconsin
United States	Northern California Retina Vitreous Associates	Mountain View	California
United States	Tennessee Retina	Nashville	Tennessee
United States	Paducah Retinal Center	Paducah	Kentucky
United States	Retina Research Unit of Wills Eye Hospital	Philadelphia	Pennsylvania
United States	Retinal Consultants of Arizona	Phoenix	Arizona
United States	Associated Retinal Consultants / William Beaumont Hospital	Royal Oak	Michigan
United States	Rocky Mountain Retina Consultants	Salt Lake City	Utah
United States	Medical Center Ophthalmology Associates	San Antonio	Texas
United States	Retina & Uveitis Consultants of Texas	San Antonio	Texas
United States	UCSF Koret Vision Center	San Francisco	California
United States	Retina Center, PC	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
NeoVista

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	No loss in ETDRS letters		12 months	No
Secondary	Change in total lesion size and CNV size by fluorescein angiography		12 months	No
Secondary	Number of rescue injections of Lucentis.		12 months	No
Secondary	Mean change in ETDRS visual acuity		12 months	No
Secondary	Incidence and severity of adverse events and ocular adverse events. Incidence of cataract changes. Incidents of radiation induced toxicity.		3 years	Yes