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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | NeoVista Ophthalmic System procedure + Lucentis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects gaining ≥ 15 ETDRS Letters | 3 years | |
| Percentage of subject gaining ≥0 ETDRS letters | 3 years | |
| Mean change in ETDRS visual acuity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tim Jackson, MD | Kings College Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Consultants of Arizona | Phoenix | Arizona | United States | |||
| Retinal Institute of Hawaii |
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| 3 years |
| Change in total lesion size and CNV size by fluorescein angiography | 3 years |
| Foveal thickness measured using OCT. | 3 years |
| Honolulu |
| Hawaii |
| 96814 |
| United States |
| Rabin Medical Center | Petah Tikva | Israel |
| Tel-Aviv Medical Center | Tel Aviv | Israel |
| Kings College Hospital | London | United Kingdom |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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