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A Study to Evaluate the Neovista Ophthalmic System for the Treatment of Subfoveal CNV in Patients With AMD That Have Failed Primary Anti-VEGF Therapy (ROSE)

This study has been completed.
Sponsor:
Information provided by:
NeoVista
ClinicalTrials.gov Identifier:
NCT00679445
First received: May 14, 2008
Last updated: July 26, 2011
Last verified: July 2011
History of Changes
  Purpose

The objective of this clinical study is to evaluate the safety and feasibility of focal delivery of radiation for the treatment of subfoveal choroidal neovascularization (CNV) in patients with age related macular degeneration that have failed Primary Anti-VEGF therapy.


Condition Intervention Phase
Wet Age-related Macular Degeneration
 Device: NeoVista Ophthalmic System
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Feasibility Study to Evaluate the Safety And Tolerability of the EPI-RAD90™ Ophthalmic System for the Treatment of Subfoveal Choroidal Neovascularization (CNV) in Patients With Age-Related Macular Degeneration (AMD) That Have Failed Primary Anti-VEGF Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by NeoVista:

Primary Outcome Measures:
  • Safety Parameters to be evaluated include incidence and severity of ocular adverse events identified by eye examinations, including visual acuity. Retinal thickness will also be measured, and stereo fundus photography will be reviewed. [ Time Frame: 3 Year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy Assessment: Preliminary efficacy will be evaluated by measuring best-corrected visual acuity (ETDRS) and AMD lesion size and leakage as assessed by fluorescein angiography at 1, 2, 3, 6, 12, 18, 24, and 36 months in the study eye. [ Time Frame: 3 Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: December 2007
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Device: NeoVista Ophthalmic System A single procedure using the NeoVista Ophthalmic System plus an injection of Lucentis.
 Device: NeoVista Ophthalmic System
A single procedure using the NeoVioasta Ophthalmic System plus an injection of Lucentis.

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 have received a minimum of three (3) prior injections (a minimum of 3 prior injections of the same compound) of anti-VEGF therapy (Lucentis® or Avastin®, subjects may have been treated previously with Macugen®, but must have been most recently treated with Lucentis® or Avastin® and met the criteria for failure below) with evidence of "failure" to respond to therapy
  • Subjects must be age 50 or older

Exclusion Criteria:

  • Subjects with prior or subfoveal CNV therapy with photodynamic therapy, intravitreal or subretinal steroids, or transpupillary thermotherapy (TTT) (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 who have been previously diagnosed with Type 1 or Type 2 diabetes mellitus. Subjects who do not have a documented diagnosis but have retinal findings consistent with Type 1 or Type 2 Diabetes Mellitus.
  • Women of child-bearing potential (female subjects must be post menopausal or surgically sterilized)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00679445

Locations
United States, Massachusetts
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States, 02114
United States, Texas
Medical Center Ophthalmology Associates
San Antonio, Texas, United States, 78240
Sponsors and Collaborators
NeoVista
Investigators
Principal Investigator: Jeffrey S Heier, MD Ophthalmic Consultants of Boston
Study Director: Jeffrey A Nau, MMS NeoVista, Inc
Principal Investigator: Michael Singer, MD Medical Center Ophthalmology Associates
  More Information

No publications provided

Responsible Party: Jeffrey Nau, MMS (Director, Clinical Affairs), NeoVista Incorporated
ClinicalTrials.gov Identifier: NCT00679445     History of Changes
Other Study ID Numbers: NVI-006
Study First Received: May 14, 2008
Last Updated: July 26, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by NeoVista:
Macular
Degeneration
AMD
Wet Age-related macular degeneration

Additional relevant MeSH terms:
Macular Degeneration
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
 Choroid Diseases
Uveal Diseases
Neovascularization, Pathologic
Metaplasia
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013