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

• ClinicalTrials.gov Identifier: NCT01016873
• Recruitment Status: Completed
• First Posted: November 20, 2009
• Results First Posted: December 5, 2014
• Last Update Posted: December 5, 2014
• Sponsor: Oraya Therapeutics, Inc.
• Information provided by (Responsible Party): Oraya Therapeutics, Inc.

Tracking Information

• First Submitted Date: November 19, 2009
• First Posted Date: November 20, 2009
• Results First Submitted Date: November 13, 2014
• Results First Posted Date: December 5, 2014
• Last Update Posted Date: December 5, 2014
• Study Start Date: November 2009
• Actual Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 1, 2014): Number of Lucentis® Injections Up To And Including Week 52 [ Time Frame: During the first 52 weeks. ]
• Original Primary Outcome Measures (submitted: November 19, 2009): Number of Lucentis® injections. [ Time Frame: During the first 52 weeks. ]

Current Secondary Outcome Measures (submitted: December 1, 2014)

• 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 ]

Original Secondary Outcome Measures (submitted: November 19, 2009)

• Change in mean VA. [ Time Frame: Weeks 12, 28, 52 and 104. ]
• Loss of < 15 letters of BCVA. [ Time Frame: Weeks 12, 28 and 52. ]
• Gain of ≥ 15 letters of BCVA. [ Time Frame: Weeks 12, 28 and 52. ]
• Gain of ≥ 0 letters of BCVA. [ Time Frame: Weeks 12, 28 and 52. ]
• Time from mandatory injection at Day 0 to the first PRN injection. [ Time Frame: To Be Determined ]
• Total number of Lucentis® injections during the first 12, 28, and 104 weeks. [ Time Frame: Week 12, 28, and 104 ]
• Change in total lesion and CNV size. [ Time Frame: Week 12, 28 and 52. ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: INTREPID - IRay Plus Anti-VEGF Treatment For Patients With Wet AMD
• 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)
• 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.
• Detailed Description: 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
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• AMD
• Wet AMD
• Age-Related Macular Degeneration
• Wet Age-Related Macular Degeneration
• Macular Degeneration
• Eye Diseases
• Retinal Diseases

Intervention

Device: IRay

Low voltage stereotactic radiotherapy system

Study Arms

• Experimental: 16 Gy IRay
  16 Gy IRay + PRN Lucentis®
  Intervention: Device: IRay
• Sham Comparator: Sham 16 Gy IRay
  Sham 16 Gy IRay + PRN Lucentis®
  Intervention: Device: IRay
• Experimental: 24 Gy IRay
  24 Gy IRay + PRN Lucentis®
  Intervention: Device: IRay
• Sham Comparator: Sham 24 Gy IRay
  Sham 24 Gy IRay + PRN Lucentis®
  Intervention: Device: IRay

• Publications *: Evans JR, Igwe C, Jackson TL, Chong V. Radiotherapy for neovascular age-related macular degeneration. Cochrane Database Syst Rev. 2020 Aug 26;8(8):CD004004. doi: 10.1002/14651858.CD004004.pub4.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 1, 2014): 230
• Original Estimated Enrollment (submitted: November 19, 2009): 132
• Actual Study Completion Date: April 2014
• Actual Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria, Czech Republic, Germany, Italy, United Kingdom

Administrative Information

• NCT Number: NCT01016873
• Other Study ID Numbers: CLH002
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Oraya Therapeutics, Inc.
• Original Responsible Party: Denis O'Shaughnessy, Ph.D./V.P., Clinical Affairs, Oraya Therapeutics, Inc.
• Current Study Sponsor: Oraya Therapeutics, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Denis O'Shaughnessy, Ph.D.; Oraya Therapeutics, Inc.

• PRS Account: Oraya Therapeutics, Inc.
• Verification Date: December 2014