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

NCT ID: NCT00454389

Last Updated: 2011-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

494 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2012-08-31

Brief Summary

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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.

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Wet Age-related Macular Degeneration
COMPLETED PHASE2

Detailed Description

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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.

Conditions

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Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Epi-Rad90™ Ophthalmic System procedure + Lucentis

Group Type EXPERIMENTAL

Epi-Rad90™ Ophthalmic System

Intervention Type DEVICE

A single procedure using the Epi-Rad90™ Ophthalmic System plus 2 injections of Lucentis administered 1 month apart

B

Lucentis only

Group Type ACTIVE_COMPARATOR

ranibizumab

Intervention Type DRUG

Lucentis injection administered monthly for the first 3 injections followed by quarterly injections

Interventions

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Epi-Rad90™ Ophthalmic System

A single procedure using the Epi-Rad90™ Ophthalmic System plus 2 injections of Lucentis administered 1 month apart

Intervention Type DEVICE

ranibizumab

Lucentis injection administered monthly for the first 3 injections followed by quarterly injections

Intervention Type DRUG

Other Intervention Names

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Lucentis

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NeoVista

INDUSTRY

Sponsor Role lead

Responsible Party

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NeoVista, Inc.

Principal Investigators

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Pravin Dugel, MD

Role: PRINCIPAL_INVESTIGATOR

Retinal Consultants of Arizona

Jeffrey A Nau, MMS

Role: STUDY_DIRECTOR

NeoVista, Inc.

Locations

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Retinal Consultants of Arizona

Phoenix, Arizona, United States

Site Status

Retina Center, PC

Tucson, Arizona, United States

Site Status

Retina-Vitreous Associates Medical

Beverly Hills, California, United States

Site Status

Retinal Diagnostic Center

Campbell, California, United States

Site Status

Northern California Retina Vitreous Associates

Mountain View, California, United States

Site Status

UCSF Koret Vision Center

San Francisco, California, United States

Site Status

Retina Group of Florida

Fort Lauderdale, Florida, United States

Site Status

Southeast Retina Center

Augusta, Georgia, United States

Site Status

Retina Institute of Hawaii

Honolulu, Hawaii, United States

Site Status

Paducah Retinal Center

Paducah, Kentucky, United States

Site Status

New England Eye Center-Tufts University

Boston, Massachusetts, United States

Site Status

Associated Retinal Consultants / William Beaumont Hospital

Royal Oak, Michigan, United States

Site Status

Eye Foundation of Kansas City

Kansas City, Missouri, United States

Site Status

Charlotte Eye Ear Nose & Throat Associates

Charlotte, North Carolina, United States

Site Status

Cincinnati Eye Institute

Cincinnati, Ohio, United States

Site Status

Retina Research Unit of Wills Eye Hospital

Philadelphia, Pennsylvania, United States

Site Status

Tennessee Retina

Nashville, Tennessee, United States

Site Status

Austin Retina Associates

Austin, Texas, United States

Site Status

Retina Research Center

Austin, Texas, United States

Site Status

Medical Center Ophthalmology Associates

San Antonio, Texas, United States

Site Status

Retina & Uveitis Consultants of Texas

San Antonio, Texas, United States

Site Status

Rocky Mountain Retina Consultants

Salt Lake City, Utah, United States

Site Status

University of Wisconsin

Madison, Wisconsin, United States

Site Status

Augenklinik Graz

Graz, , Austria

Site Status

Klinik und Poliklinik für Augenheilkunde der Universität Leipzig AöR

Leipzig, , Germany

Site Status

Universitätsklinik und polyklinik für Augenkranke

Würzburg, , Germany

Site Status

Institute of Clinical Science, Ophthalmic Research Centre, Royal Victoria Hospital

Belfast, , Ireland

Site Status

Sourasky Medical Center

Tel Aviv, , Israel

Site Status

Oftalmo Salud Eye Institute

Lima, , Peru

Site Status

Institutio de Microcirugia Ocular-Barcelona

Barcelona, , Spain

Site Status

University of Geneva

Geneva, , Switzerland

Site Status

Kings College Hospital

London, , United Kingdom

Site Status

Countries

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United States Austria Germany Ireland Israel Peru Spain Switzerland United Kingdom

References

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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.

Reference Type DERIVED
PMID: 32844399 (View on PubMed)

Other Identifiers

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NVI-114

Identifier Type: -

Identifier Source: org_study_id

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