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)

July 26, 2011 updated by: NeoVista

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

32

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Petach-Tikva, Israel
        • Rabin Medical Center
      • Tel-Aviv, Israel
        • Tel-Aviv Medical Center
  • United Kingdom
      • London, United Kingdom
        • Kings College Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States
        • Retina Consultants of Arizona
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • Retinal Institute of Hawaii

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NeoVista

Investigators

  • Study Director: Tim Jackson, MD, Kings College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (ANTICIPATED)

November 1, 2012

Study Completion (ANTICIPATED)

November 1, 2012

Study Registration Dates

First Submitted

December 15, 2008

First Submitted That Met QC Criteria

December 15, 2008

First Posted (ESTIMATE)

December 17, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

July 27, 2011

Last Update Submitted That Met QC Criteria

July 26, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NVI-008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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