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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2012-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Age Related Macular Degeneration

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

NeoVista Ophthalmic System procedure + Lucentis

Group Type EXPERIMENTAL

NeoVista Ophthalmic System

Intervention Type DEVICE

A single procedure with the NeoVista Ophthalmic System, with Lucentis (0.5mg) administered on an as needed basis for three years.

Interventions

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NeoVista Ophthalmic System

A single procedure with the NeoVista Ophthalmic System, with Lucentis (0.5mg) administered on an as needed basis for three years.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No