An Open-label Study to Evaluate the Clinical and Economic Benefits of I-Ray in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration

Study Overview
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Brief Summary
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The purpose of this study is to confirm the clinical and economic benefits of IRay treatment with respect to the number of anti-VEGF injections and frequency of visits during the first year after treatment for patients with wet Age-related Macular Degeneration (AMD).

Detailed Description
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The objective of this study is to confirm the clinical and economic benefits of low voltage external beam radiotherapy with the IRay with respect to number of anti-VEGF injections and frequency of ophthalmic assessments during the one year interval following treatment in subjects with neovascular AMD.

Official Title
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A Multicenter, Open-label Study to Evaluate the Clinical and Economic Benefits of Low Voltage Stereotactic Radiotherapy in Subjects With Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)

Conditions
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Age-Related Macular Degeneration, Wet Macular Degeneration, Macular Degeneration, Eye Diseases, Retinal Diseases

Intervention / Treatment
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* Device: IRay


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must have neovascular AMD and have received an anti-VEGF injections within 1 month prior to entering the study, and have the need for further treatment with anti-VEGF therapy. Must have a total lesion size of <12 disc areas and a CNV lesion with the greatest linear dimension of <6 mm, but not greater than 3 mm from the center of the fovea to the furthest point on lesion perimeter. Must have provided informed consent, documented it in writing, and have been given a copy of the signed informed consent form. Must be willing and able to return for scheduled treatment and follow-up examinations for the 3-year duration of the study. Must be at least 50 years of age. Women must be post-menopausal ≥1 year or surgically sterilized. Must have best corrected visual acuity of greater than or equal to 24 letters in the study eye and at least 20 letters in the fellow eye (if both eyes meet all the study criteria, then the eye with the worst vision should be selected as the study eye). Exclusion Criteria: Present with any implanted device, where the device labeling specifically contraindicates subjects undergoing x-rays. An axial length of <20 mm (because of limitations of the IRay device) or >26 mm (to exclude subjects with pathologic myopia). Evidence of diabetes or retinal findings consistent with diabetic retinopathy, or retinopathy for any cause. Prior or concurrent therapies in the study eye for age related macular degeneration (other than intravitreal anti-VEGF), including submacular surgery, subfoveal thermal laser photocoagulation (with or without photographic evidence), transpupillary thermotherapy (TTT) and ocular photodynamic therapy.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 16 Gy IRay<br>16 Gy IRay + PRN Lucentis® | Device: IRay<br>* Approved dose of Anti-VEGF injection given at Day 0 followed by treatment with 16 Gy dose of IRay up to 14 days later.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of anti-VEGF injections during the first 12 months |  | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first Anti-VEGF injection |  | Up to Month 12 | 
| Change in mean best-corrected visual acuity in the treated eye at month 12 |  | Month 12 | 
| Visual Functioning Questionnaire - 25 (VFQ-25) |  | Baseline & Month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AMD, Wet AMD