INTREPID - IRay Plus Anti-VEGF Treatment For Patients With Wet AMD (INTREPID)
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| ClinicalTrials.gov Identifier: NCT01016873 |
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Recruitment Status :
Completed
First Posted : November 20, 2009
Results First Posted : December 5, 2014
Last Update Posted : December 5, 2014
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Sponsor:
Oraya Therapeutics, Inc.
Information provided by (Responsible Party):
Oraya Therapeutics, Inc.
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| AMD Wet AMD Age-Related Macular Degeneration Wet Age-Related Macular Degeneration Macular Degeneration Eye Diseases Retinal Diseases | Device: IRay | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 230 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | 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) |
| Study Start Date : | November 2009 |
| Actual Primary Completion Date : | May 2012 |
| Actual Study Completion Date : | April 2014 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Age-related macular degeneration
| Arm | Intervention/treatment |
|---|---|
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Experimental: 16 Gy IRay
16 Gy IRay + PRN Lucentis®
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Device: IRay
Low voltage stereotactic radiotherapy system |
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Sham Comparator: Sham 16 Gy IRay
Sham 16 Gy IRay + PRN Lucentis®
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Device: IRay
Low voltage stereotactic radiotherapy system |
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Experimental: 24 Gy IRay
24 Gy IRay + PRN Lucentis®
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Device: IRay
Low voltage stereotactic radiotherapy system |
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Sham Comparator: Sham 24 Gy IRay
Sham 24 Gy IRay + PRN Lucentis®
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Device: IRay
Low voltage stereotactic radiotherapy system |
Primary Outcome Measures :
- Number of Lucentis® Injections Up To And Including Week 52 [ Time Frame: During the first 52 weeks. ]
Secondary Outcome Measures :
- Change in Mean Visual Acuity (VA) [ Time Frame: Weeks 12, 28, 52 and 104. ]
- Percentage (Pct.) of Patients (Pts.) Losing < 15 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.) [ Time Frame: Weeks 12, 28 and 52. ]
- Percentage (Pct.) of Patients (Pts.) Gaining ≥ 15 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.) [ Time Frame: Weeks 12, 28 and 52. ]
- Percentage (Pct.) of Patients (Pts.) Gaining ≥ 0 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.) [ Time Frame: Weeks 12, 28 and 52. ]
- Time From Mandatory Injection at Day 0 to the First PRN Injection. [ Time Frame: 52 Weeks ]
- Total Number (No.) of Lucentis® Injections (Inject.) During The First 12, 28, and 104 Weeks. [ Time Frame: Week 12, 28, and 104 ]
- Mean Change in Choroidal Neovascularization (CNV) as % of Lesion on Fluorescein Angiography (FA) From Baseline to Week 52 [ Time Frame: Week 52 ]
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| Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01016873
Locations
Show 21 study locations
Sponsors and Collaborators
Oraya Therapeutics, Inc.
Investigators
| Study Director: | Denis O'Shaughnessy, Ph.D. | Oraya Therapeutics, Inc. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Oraya Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT01016873 |
| Other Study ID Numbers: |
CLH002 |
| First Posted: | November 20, 2009 Key Record Dates |
| Results First Posted: | December 5, 2014 |
| Last Update Posted: | December 5, 2014 |
| Last Verified: | December 2014 |
Keywords provided by Oraya Therapeutics, Inc.:
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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 |
Additional relevant MeSH terms:
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Macular Degeneration Eye Diseases Retinal Diseases Retinal Degeneration |