INTREPID - IRay Plus Anti-VEGF Treatment For Patients With Wet AMD

Study Overview
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Brief Summary
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The purpose of this study is to confirm the safety and establish the effectiveness of two doses from the IRay System for the treatment of wet AMD.

Detailed Description
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The purpose of this study is to confirm the safety of low voltage external beam radiotherapy using the IRay System at two dose levels for the treatment of CNV secondary to neovascular AMD and to determine if the IRay System is effective in sparing the number of Lucentis injections during the first 12 months.

Official Title
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A Double-masked, Sham Controlled, Dose-ranging Study to Evaluate the Safety and Effectiveness of Low Voltage Stereotactic Radiosurgery in Patients With Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)

Conditions
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AMD, Wet AMD, Age-Related Macular Degeneration, Wet Age-Related 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: Patients must have neovascular AMD diagnosed within the previous 3 years, have received at least 3 injections with Lucentis® or Avastin® within the previous year and have the need for treatment with anti-VEGF therapy due to increased fluid or persistent cysts on OCT, or leakage on FA. Patients 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 the lesion perimeter. The distance from the center of the fovea to the nearest edge of the optic disc should be not less than 3 mm. Patients must Patient must be at least 50 years of age. Women must be post-menopausal ≥1 year or surgically sterilized, or a pregnancy screen must be performed prior to the study and a reliable form of contraception approved by the investigator must be maintained during the study. Patient must have best corrected visual acuity of 75 to 25 letters in the study eye and at least 20 letters in the fellow eye. Exclusion Criteria: CNV due to causes other than AMD, including ocular histoplasmosis syndrome, angioid streaks, multifocal choroiditis, choroidal rupture, or pathologic myopia (spherical equivalent ≥ -8 diopters). An axial length of ≤20 mm or ≥26 mm. Previously diagnosed with Diabetes Mellitus and/or an HbA1c of >6.5%, and with retinal findings consistent with diabetic retinopathy. Prior or concurrent therapies for age related macular degeneration including submacular surgery, subfoveal thermal laser photocoagulation (with or without photographic evidence), transpupillary thermotherapy (TTT), ocular photodynamic therapy, radiation therapy to the head or neck in the study eye. Previous posterior vitrectomy, or any surgery in the study eye within 6 months or YAG capsulotomy within 3 months prior to the screening visit.

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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 16 Gy IRay<br>16 Gy IRay + PRN Lucentis® | Device: IRay<br>* Low voltage stereotactic radiotherapy system<br>|
| Sham Comparator: Sham 16 Gy IRay<br>Sham 16 Gy IRay + PRN Lucentis® | Device: IRay<br>* Low voltage stereotactic radiotherapy system<br>|
| Experimental: 24 Gy IRay<br>24 Gy IRay + PRN Lucentis® | Device: IRay<br>* Low voltage stereotactic radiotherapy system<br>|
| Sham Comparator: Sham 24 Gy IRay<br>Sham 24 Gy IRay + PRN Lucentis® | Device: IRay<br>* Low voltage stereotactic radiotherapy system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Lucentis® Injections Up To And Including Week 52 |  | During the first 52 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean Visual Acuity (VA) |  | Weeks 12, 28, 52 and 104. | 
| Percentage (Pct.) of Patients (Pts.) Losing < 15 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.) |  | Weeks 12, 28 and 52. | 
| Percentage (Pct.) of Patients (Pts.) Gaining ≥ 15 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.) |  | Weeks 12, 28 and 52. | 
| Percentage (Pct.) of Patients (Pts.) Gaining ≥ 0 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.) |  | Weeks 12, 28 and 52. | 
| Time From Mandatory Injection at Day 0 to the First PRN Injection. |  | 52 Weeks | 
| Total Number (No.) of Lucentis® Injections (Inject.) During The First 12, 28, and 104 Weeks. |  | Week 12, 28, and 104 | 
| Mean Change in Choroidal Neovascularization (CNV) as % of Lesion on Fluorescein Angiography (FA) From Baseline to Week 52 |  | Week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oraya, Oraya Therapeutics, Inc., low voltage stereotactic radiotherapy, radiotherapy, IRay, Ranibizumab, Lucentis, AMD, Macular Degeneration, xray, radiation, x ray, external beam radiation, radiosurgery