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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)

Primary Purpose

Age Related Macular Degeneration

Status
Unknown status
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
NeoVista Ophthalmic System
Sponsored by
NeoVista
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age Related Macular Degeneration focused on measuring Brachytherapy, EpiRad, Macular Degeneration, Ranibizumab

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Retina Consultants of Arizona
  • Retinal Institute of Hawaii
  • Rabin Medical Center
  • Tel-Aviv Medical Center
  • Kings College Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

NeoVista Ophthalmic System procedure + Lucentis

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 15, 2008
Last Updated
July 26, 2011
Sponsor
NeoVista
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1. Study Identification

Unique Protocol Identification Number
NCT00809419
Brief Title
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
Acronym
MERITAGE
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 Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2008 (undefined)
Primary Completion Date
November 2012 (Anticipated)
Study Completion Date
November 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
NeoVista

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Macular Degeneration
Keywords
Brachytherapy, EpiRad, Macular Degeneration, Ranibizumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
NeoVista Ophthalmic System procedure + Lucentis
Intervention Type
Device
Intervention Name(s)
NeoVista Ophthalmic System
Intervention Description
A single procedure with the NeoVista Ophthalmic System, with Lucentis (0.5mg) administered on an as needed basis for three years.
Primary Outcome Measure Information:
Title
Number of re-treatment injections of anti-VEGF (Lucentis) therapy
Time Frame
3 years
Title
Percentage of subjects losing less than 15 ETDRS letters
Time Frame
3 years
Title
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 Measure Information:
Title
Percentage of subjects gaining ≥ 15 ETDRS Letters
Time Frame
3 years
Title
Percentage of subject gaining ≥0 ETDRS letters
Time Frame
3 years
Title
Mean change in ETDRS visual acuity
Time Frame
3 years
Title
Change in total lesion size and CNV size by fluorescein angiography
Time Frame
3 years
Title
Foveal thickness measured using OCT.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim Jackson, MD
Organizational Affiliation
Kings College Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Retina Consultants of Arizona
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Retinal Institute of Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Rabin Medical Center
City
Petach-Tikva
Country
Israel
Facility Name
Tel-Aviv Medical Center
City
Tel-Aviv
Country
Israel
Facility Name
Kings College Hospital
City
London
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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