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

Age Related Macular Degeneration Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00809419
• Other study ID #: NVI-008
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: December 15, 2008
• Last updated: July 26, 2011
• Start date: November 2008
• Est. completion date: November 2012

Study information

• Verified date: July 2011
• Source: NeoVista
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyIsrael: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Choroidal Neovascularization
• Macular Degeneration

Intervention

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.

Locations

Country	Name	City	State
Israel	Rabin Medical Center	Petach-Tikva
Israel	Tel-Aviv Medical Center	Tel-Aviv
United Kingdom	Kings College Hospital	London
United States	Retinal Institute of Hawaii	Honolulu	Hawaii
United States	Retina Consultants of Arizona	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
NeoVista

Countries where clinical trial is conducted

United States,  Israel,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of re-treatment injections of anti-VEGF (Lucentis) therapy		3 years	No
Primary	Percentage of subjects losing less than 15 ETDRS letters		3 years	No
Primary	Safety Assessment: Incidence and severity of averse events and ocular AEs. Incidence of cataract changes. Incidence of radiation induced toxicity		3 years	Yes
Secondary	Percentage of subjects gaining = 15 ETDRS Letters		3 years	No
Secondary	Percentage of subject gaining =0 ETDRS letters		3 years	No
Secondary	Mean change in ETDRS visual acuity		3 years	No
Secondary	Change in total lesion size and CNV size by fluorescein angiography		3 years	No
Secondary	Foveal thickness measured using OCT.		3 years	No