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

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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.

November 19, 2009
November 20, 2009
November 13, 2014
December 5, 2014
December 5, 2014
November 2009
May 2012   (Final data collection date for primary outcome measure)
Number of Lucentis® Injections Up To And Including Week 52 [ Time Frame: During the first 52 weeks. ]
Number of Lucentis® injections. [ Time Frame: During the first 52 weeks. ]
Complete list of historical versions of study NCT01016873 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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. ]
Not Provided
Not Provided
 
INTREPID - IRay Plus Anti-VEGF Treatment For Patients With Wet AMD
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)
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.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • AMD
  • Wet AMD
  • Age-Related Macular Degeneration
  • Wet Age-Related Macular Degeneration
  • Macular Degeneration
  • Eye Diseases
  • Retinal Diseases
Device: IRay
Low voltage stereotactic radiotherapy system
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
230
132
April 2014
May 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
50 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Czech Republic,   Germany,   Italy,   United Kingdom
 
 
NCT01016873
CLH002
Yes
Not Provided
Not Provided
Oraya Therapeutics, Inc.
Oraya Therapeutics, Inc.
Not Provided
Study Director: Denis O'Shaughnessy, Ph.D. Oraya Therapeutics, Inc.
Oraya Therapeutics, Inc.
December 2014

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