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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 16 Gy IRay | Experimental | 16 Gy IRay + PRN Lucentis® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IRay | Device | Approved dose of Anti-VEGF injection given at Day 0 followed by treatment with 16 Gy dose of IRay up to 14 days later. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of anti-VEGF injections during the first 12 months | 12 Months |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Manchester Royal Eye Hospital | Recruiting | Manchester | M13 9WL | United Kingdom |
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| Baseline & Month 12 |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D057135 | Wet Macular Degeneration |
| D005128 | Eye Diseases |
| D012164 | Retinal Diseases |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
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