A Study of the NeoVista Ophthalmic System for the Treatment of Subfoveal CNV Associated With Wet AMD in Patients That Require Persistent Anti-VEGF Therapy - Full Text View

Sponsored by:	NeoVista
Information provided by:	NeoVista
ClinicalTrials.gov Identifier:	NCT00809419

Purpose

The objective of the MERITAGE 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) in patients that require persistent injections of Anti-VEGF therapy to maintain an adequate response to treatment.

Condition	Intervention	Phase
Age Related Macular Degeneration	Device: NeoVista Ophthalmic System	Phase I Phase II

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Bevacizumab Ranibizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Study of the NeoVista Ophthalmic System for the Treatment of Subfoveal Choroidal Neovascularization Associated With Wet Age-Related Macular Degeneration in Patients That Require Persistent Anti-VEGF Therapy

Further study details as provided by NeoVista:

Primary Outcome Measures:

Number of re-treatment injections of anti-VEGF (Avastin or Lucentis) therapy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Percentage of subjects losing less than 15 ETDRS letters [ 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 ]

Estimated Enrollment:	32
Study Start Date:	November 2008
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental NeoVista Ophthalmic System procedure + Lucentis or Avastin	Device: NeoVista Ophthalmic System A single procedure with the NeoVista Ophthalmic System, with Lucentis (0.5mg) or Avastin (1.25mg) administered on an as needed basis for three years.

Detailed Description:

Therapeutic advances in the arena of neovascular age-related macular degeneration (AMD) have provided multiple treatment options for the disease. Brachytherapy 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. The current treatment for neovascualar AMD involves multiple injections over an indefinite period of time. This trial will evaluate whether treatment with brachytherapy can reduce or eliminate the need for continued injections.

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 completed anti-VEGF induction treatment, defined as the first 3 months of treatment. Following the induction period, subjects must have required at least 5 additional injections of Avastin or Lucentis in the 12 months preceding enrollment, or 3 additional injections of Avastin or Lucentis in the 6 months preceding enrollment, given on an as needed basis. Subjects may have previously received Macugen, although must meet the criteria above for Lucentis or Avastin.
Subjects must be age 50 or older

Exclusion Criteria:

Subjects with prior or concurrent subfoveal CNV therapy with agents, surgery or devices (excluding Macugen, Avastin, or Lucentis) including thermal laser photocoagulation (with or without photographic evidence), photodynamic therapy, intravitreal or subretinal steroids, and transpupillary thermotherapy (TTT)
Subjects who underwent previous radiation therapy to the eye, head or neck
Subjects who have been previously diagnosed with Type I or Type II Diabetes Mellitus. Subjects that DO NOT have a documented diagnosis, but have retinal findings consistent with Type I or Type II Diabetes Mellitus.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00809419

Locations

United States, Arizona
Retina Consultants of Arizona	Recruiting
Phoenix, Arizona, United States
Contact: Jennifer Cornelius clinicaltrials@neovistainc.com
Principal Investigator: Pravin Dugel, MD

Sponsors and Collaborators

NeoVista

More Information

Responsible Party:	NeoVista, Inc. ( Jeffrey A. Nau, MMS, Director of Clinical Affairs )
Study ID Numbers:	NVI-008
Study First Received:	December 15, 2008
Last Updated:	December 15, 2008
ClinicalTrials.gov Identifier:	NCT00809419
Health Authority:	United States: Food and Drug Administration

Keywords provided by NeoVista:

Brachytherapy
EpiRad
Macular Degeneration
Ranibizumab
Bevacizumab

Study placed in the following topic categories:

Metaplasia
Eye Diseases
Choroid Diseases
Retinal Degeneration
Macular Degeneration

Bevacizumab
Neovascularization, Pathologic
Retinal Diseases
Retinal degeneration
Choroidal Neovascularization

Additional relevant MeSH terms:

Uveal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on January 14, 2009