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 (MERITAGE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00809419
Recruitment Status : Unknown
Verified July 2011 by NeoVista.
Recruitment status was:  Active, not recruiting
First Posted : December 17, 2008
Last Update Posted : July 27, 2011
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Age Related Macular Degeneration Device: NeoVista Ophthalmic System Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : November 2008
Estimated Primary Completion Date : November 2012
Estimated Study Completion Date : November 2012

Arm Intervention/treatment
Experimental: A
NeoVista Ophthalmic System procedure + Lucentis
Device: NeoVista Ophthalmic System
A single procedure with the NeoVista Ophthalmic System, with Lucentis (0.5mg) administered on an as needed basis for three years.

Primary Outcome Measures :
  1. Number of re-treatment injections of anti-VEGF (Lucentis) therapy [ Time Frame: 3 years ]
  2. Percentage of subjects losing less than 15 ETDRS letters [ Time Frame: 3 years ]
  3. Safety Assessment: Incidence and severity of averse events and ocular AEs. Incidence of cataract changes. Incidence of radiation induced toxicity [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Percentage of subjects gaining ≥ 15 ETDRS Letters [ Time Frame: 3 years ]
  2. Percentage of subject gaining ≥0 ETDRS letters [ Time Frame: 3 years ]
  3. Mean change in ETDRS visual acuity [ Time Frame: 3 years ]
  4. Change in total lesion size and CNV size by fluorescein angiography [ Time Frame: 3 years ]
  5. Foveal thickness measured using OCT. [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00809419

United States, Arizona
Retina Consultants of Arizona
Phoenix, Arizona, United States
United States, Hawaii
Retinal Institute of Hawaii
Honolulu, Hawaii, United States, 96814
Rabin Medical Center
Petach-Tikva, Israel
Tel-Aviv Medical Center
Tel-Aviv, Israel
United Kingdom
Kings College Hospital
London, United Kingdom
Sponsors and Collaborators
Study Director: Tim Jackson, MD Kings College Hospital

Responsible Party: Jeffrey A. Nau, MMS, Director of Clinical Affairs, NeoVista, Inc., Kings College Hospital; London, UK Identifier: NCT00809419     History of Changes
Other Study ID Numbers: NVI-008
First Posted: December 17, 2008    Key Record Dates
Last Update Posted: July 27, 2011
Last Verified: July 2011

Keywords provided by NeoVista:
Macular Degeneration

Additional relevant MeSH terms:
Macular Degeneration
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Choroid Diseases
Uveal Diseases
Neovascularization, Pathologic
Pathologic Processes
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents