MERITAGE: 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

Sponsor

NeoVista (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00809419

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

6.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

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 Design

Study Type:

Interventional

Anticipated 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 :

Nov 1, 2008

Anticipated Primary Completion Date :

Nov 1, 2012

Anticipated Study Completion Date :

Nov 1, 2012

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Retina Consultants of Arizona	Phoenix	Arizona	United States
2	Retinal Institute of Hawaii	Honolulu	Hawaii	United States	96814
3	Rabin Medical Center	Petach-Tikva		Israel
4	Tel-Aviv Medical Center	Tel-Aviv		Israel
5	Kings College Hospital	London		United Kingdom