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 recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by NeoVista.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
NeoVista
ClinicalTrials.gov Identifier:
NCT00809419
First received: December 15, 2008
Last updated: July 26, 2011
Last verified: July 2011
  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 1
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 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

Resource links provided by NLM:


Further study details as provided by NeoVista:

Primary Outcome Measures:
  • Number of re-treatment injections of anti-VEGF (Lucentis) therapy [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Percentage of subjects losing less than 15 ETDRS letters [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Safety Assessment: Incidence and severity of averse events and ocular AEs. Incidence of cataract changes. Incidence of radiation induced toxicity [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percentage of subjects gaining ≥ 15 ETDRS Letters [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Percentage of subject gaining ≥0 ETDRS letters [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Mean change in ETDRS visual acuity [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Change in total lesion size and CNV size by fluorescein angiography [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Foveal thickness measured using OCT. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: November 2008
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: Jeffrey A. Nau, MMS, Director of Clinical Affairs, NeoVista, Inc., Kings College Hospital; London, UK
ClinicalTrials.gov Identifier: NCT00809419     History of Changes
Other Study ID Numbers: NVI-008
Study First Received: December 15, 2008
Last Updated: July 26, 2011
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Israel: Ministry of Health

Keywords provided by NeoVista:
Brachytherapy
EpiRad
Macular Degeneration
Ranibizumab

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 July 28, 2014