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

Sponsored by:	NeoVista
Information provided by:	NeoVista
ClinicalTrials.gov Identifier:	NCT00454389

Purpose

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.

Condition	Intervention	Phase
Macular Degeneration	Device: Epi-Rad90™ Ophthalmic System Drug: ranibizumab	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration Radiation Therapy

Drug Information available for: Ranibizumab

U.S. FDA Resources

Further study details as provided by NeoVista:

Primary Outcome Measures:

Percentage of subjects losing fewer than 15 letters of best corrected visual acuity score at 12 months compared to baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of subjects gaining ≥ 15 ETDRS letters [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Percentage of subjects gaining ≥ 0 ETDRS letters [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Mean change in ETDRS visual acuity [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	450
Study Start Date:	April 2007
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Epi-Rad90™ Ophthalmic System procedure + Lucentis	Device: Epi-Rad90™ Ophthalmic System A single procedure using the Epi-Rad90™ Ophthalmic System plus 2 injections of Lucentis administered 1 month apart
B: Active Comparator Lucentis only	Drug: ranibizumab Lucentis injection administered monthly for the first 3 injections followed by quarterly injections

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

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00454389

Contacts

Contact: Jeffrey A Nau, MMS

clinicaltrials@neovistainc.com

Show 36 Study Locations

Sponsors and Collaborators

NeoVista

Investigators

Principal Investigator:	Nelson R Sabates, MD	Eye Foundation of Kansas City, UMKC
Study Director:	Jeffrey A Nau, MMS	NeoVista, Inc.

More Information

No publications provided

Responsible Party:	NeoVista, Inc. ( NeoVista, Inc./Jeffrey A. Nau, MMS, Director of Clinical Affairs )
Study ID Numbers:	NVI-114
Study First Received:	March 28, 2007
Last Updated:	November 21, 2008
ClinicalTrials.gov Identifier:	NCT00454389 History of Changes
Health Authority:	United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices; Austria: Federal Ministry for Health and Women; Switzerland: Swissmedic; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Brazil: National Health Surveillance Agency; Spain: Ministry of Health and Consumption; Israel: Ministry of Health; Peru: Ministry of Health

Keywords provided by NeoVista:

Macular
Degeneration
AMD
Wet Age-Related macular degeneration

Study placed in the following topic categories:

Uveal Diseases
Metaplasia
Eye Diseases
Choroid Diseases
Retinal Degeneration

Macular Degeneration
Neovascularization, Pathologic
Retinal Diseases
Choroidal Neovascularization

Additional relevant MeSH terms:

Uveal Diseases
Pathologic Processes
Metaplasia
Eye Diseases
Choroid Diseases

Retinal Degeneration
Macular Degeneration
Neovascularization, Pathologic
Retinal Diseases
Choroidal Neovascularization

ClinicalTrials.gov processed this record on July 02, 2009