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

NCT00809419 | Unknown Phase 1

• 1 other identifier: NVI-008
• Study Type: interventional
• Target: 32
• Locations: 3 countries
• Sites: 5

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.

Conditions

Age Related Macular Degeneration

Keywords

Brachytherapy; EpiRad; Macular Degeneration; Ranibizumab

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 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

Study Arms (1)

A

EXPERIMENTAL

NeoVista Ophthalmic System procedure + Lucentis

Device: NeoVista Ophthalmic System

Interventions

NeoVista Ophthalmic System DEVICE

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

A

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• NeoVista: lead

Study Sites (5)

Retina Consultants of Arizona

Phoenix, Arizona, United States

Location

Retinal Institute of Hawaii

Honolulu, Hawaii, 96814, United States

Location

Rabin Medical Center

Petah Tikva, Israel

Location

Tel-Aviv Medical Center

Tel Aviv, Israel

Location

Kings College Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Tim Jackson, MD

  Kings College Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 15, 2008
• First Posted: December 17, 2008
• Study Start: November 1, 2008
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: July 27, 2011

Record last verified: 2011-07

Locations

IL (2); US (2); GB (1)