Age Related Macular Degeneration
Conditions
Keywords
Brachytherapy, EpiRad, Macular Degeneration, Ranibizumab
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.
Interventions
A single procedure with the NeoVista Ophthalmic System, with Lucentis (0.5mg) administered on an as needed basis for three years.
Sponsors
NeoVista
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Change in total lesion size and CNV size by fluorescein angiography | 3 years |
| Percentage of subjects gaining ≥ 15 ETDRS Letters | 3 years |
| Foveal thickness measured using OCT. | 3 years |
| Percentage of subject gaining ≥0 ETDRS letters | 3 years |
| Mean change in ETDRS visual acuity | 3 years |
Countries
Israel, United Kingdom, United States
Outcome results
None listed