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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
Oraya Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE November 19, 2009
First Posted Date  ICMJE November 20, 2009
Results First Submitted Date  ICMJE November 13, 2014
Results First Posted Date  ICMJE December 5, 2014
Last Update Posted Date December 5, 2014
Study Start Date  ICMJE November 2009
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (submitted: November 19, 2009)
Number of Lucentis® injections. [ Time Frame: During the first 52 weeks. ]
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE INTREPID - IRay Plus Anti-VEGF Treatment For Patients With Wet AMD
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • AMD
  • Wet AMD
  • Age-Related Macular Degeneration
  • Wet Age-Related Macular Degeneration
  • Macular Degeneration
  • Eye Diseases
  • Retinal Diseases
Intervention  ICMJE Device: IRay
Low voltage stereotactic radiotherapy system
Study Arms  ICMJE
  • 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:CD004004. doi: 10.1002/14651858.CD004004.pub4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 1, 2014)
230
Original Estimated Enrollment  ICMJE
 (submitted: November 19, 2009)
132
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Czech Republic,   Germany,   Italy,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01016873
Other Study ID Numbers  ICMJE CLH002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Oraya Therapeutics, Inc.
Study Sponsor  ICMJE Oraya Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Denis O'Shaughnessy, Ph.D. Oraya Therapeutics, Inc.
PRS Account Oraya Therapeutics, Inc.
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP