Clinical trial NCT00809419: 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
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Age Related Macular Degeneration
Keywords: Brachytherapy
EpiRad
Macular Degeneration
Ranibizumab
Lead sponsor: NeoVista
Sponsor class: INDUSTRY
First posted: 2008-12-17
Enrollment: 32
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of re-treatment injections of anti-VEGF (Lucentis) therapy
timeFrame: 3 years
measure: Percentage of subjects losing less than 15 ETDRS letters
timeFrame: 3 years
measure: Safety Assessment: Incidence and severity of averse events and ocular AEs. Incidence of cataract changes. Incidence of radiation induced toxicity
timeFrame: 3 years
Secondary outcomes:
measure: Percentage of subjects gaining ≥ 15 ETDRS Letters
timeFrame: 3 years
measure: Percentage of subject gaining ≥0 ETDRS letters
timeFrame: 3 years
measure: Mean change in ETDRS visual acuity
timeFrame: 3 years
measure: Change in total lesion size and CNV size by fluorescein angiography
timeFrame: 3 years
measure: Foveal thickness measured using OCT.
timeFrame: 3 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Retina Consultants of Arizona
state: Arizona
city: Honolulu
country: United States
facility: Retinal Institute of Hawaii
state: Hawaii
city: Petach-Tikva
country: Israel
facility: Rabin Medical Center
city: Tel-Aviv
country: Israel
facility: Tel-Aviv Medical Center
city: London
country: United Kingdom
facility: Kings College Hospital
Study officials:
affiliation: Kings College Hospital
name: Tim Jackson, MD
role: STUDY_DIRECTOR
References: