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

Status unconfirmed · Phase 1/Phase 2

Conditions studied: Age Related Macular Degeneration

In brief

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.

Key facts

Study ID

NCT00809419

Run by

NeoVista

People needed

32

Starts

2008-11-01

Expected to finish

2012-11-01

Last updated by the study team

2011-07-27

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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