Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Information provided by (Responsible Party):
Oraya Therapeutics, Inc. Identifier:
First received: November 19, 2009
Last updated: December 1, 2014
Last verified: December 2014
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 Intervention Phase
Age-Related Macular Degeneration
Wet Age-Related Macular Degeneration
Macular Degeneration
Eye Diseases
Retinal Diseases
Device: IRay
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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)

Resource links provided by NLM:

Further study details as provided by Oraya Therapeutics, Inc.:

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 ]

Enrollment: 230
Study Start Date: November 2009
Study Completion Date: April 2014
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 16 Gy IRay
16 Gy IRay + PRN Lucentis®
Device: IRay
Low voltage stereotactic radiotherapy system
Sham Comparator: Sham 16 Gy IRay
Sham 16 Gy IRay + PRN Lucentis®
Device: IRay
Low voltage stereotactic radiotherapy system
Experimental: 24 Gy IRay
24 Gy IRay + PRN Lucentis®
Device: IRay
Low voltage stereotactic radiotherapy system
Sham Comparator: Sham 24 Gy IRay
Sham 24 Gy IRay + PRN Lucentis®
Device: IRay
Low voltage stereotactic radiotherapy system

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.

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01016873

LKH Graz
Graz, Austria, A-8036
Universitätsklinik Innsbruck
Innsbruck, Austria, A-6020
Hanusch Krankenhaus Wien
Wien, Austria, A-1140
Ordination Prof. Michael Stur
Wien, Austria, A-1180
Czech Republic
Fakultni Nemocnice Brno
Brno, Czech Republic, 625 00
Fakultni nemocnice Hradec Kralove
Hradec Kralove, Czech Republic, 500 05
Fakultni Nemocnice Olomouc
Olomouc, Czech Republic, 775 20
Faculty Hospital Kralovske Vinohrady
Prague, Czech Republic, 100 34
General Faculty Hospital Prague
Prague, Czech Republic, 128 08
Military Hospital Prague
Prague, Czech Republic, 169 02
Kopfklinikum University Hospital Heidelberg
Heidelberg, Baden-Württemberg, Germany, 69120
University Eye Hospital
Tübingen, Baden-Württemberg, Germany, 72076
Klinik für Augenheilkunde
Neubrandenburg, Mecklenburg-Vorpommern, Germany, 17036
Università Vita-Salute Istituto Scientifico San Raffaele
Milano, Italy, I-20132
United Kingdom
Royal Victoria Hospital
Belfast, United Kingdom, BT12 6BA
Bradford Royal Infirmary
Bradford, United Kingdom, BDP 6RJ
Torbay Hospital
Devon, United Kingdom, TQ2 7AA
King's College
London, United Kingdom, SE5 9RS
Manchester Royal Eye Hospital
Manchester, United Kingdom, M13 9WL
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
Royal Wolverhampton Hospital NHS Foundation Trust
Wolverhampton, United Kingdom, WV3 9QR
Sponsors and Collaborators
Oraya Therapeutics, Inc.
Study Director: Denis O'Shaughnessy, Ph.D. Oraya Therapeutics, Inc.
  More Information

Additional Information:
Responsible Party: Oraya Therapeutics, Inc. Identifier: NCT01016873     History of Changes
Other Study ID Numbers: CLH002
Study First Received: November 19, 2009
Results First Received: November 13, 2014
Last Updated: December 1, 2014

Keywords provided by Oraya Therapeutics, Inc.:
Macular Degeneration
Oraya Therapeutics, Inc.
low voltage stereotactic radiotherapy
x ray
external beam radiation

Additional relevant MeSH terms:
Macular Degeneration
Eye Diseases
Retinal Diseases
Choroidal Neovascularization
Retinal Degeneration
Choroid Diseases
Uveal Diseases
Neovascularization, Pathologic
Pathologic Processes
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents processed this record on May 24, 2017