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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Oraya Therapeutics, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Oraya Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01016873
First received: November 19, 2009
Last updated: June 12, 2012
Last verified: June 2012
  Purpose

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
AMD
Wet AMD
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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. [ Time Frame: During the first 52 weeks. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in mean Visual Acuity (VA). [ Time Frame: Weeks 12, 28, 52 and 104. ] [ Designated as safety issue: No ]
  • Loss of < 15 letters of Best Correct Visual Acuity (BCVA). [ Time Frame: Weeks 12, 28 and 52. ] [ Designated as safety issue: No ]
  • Gain of ≥ 15 letters of BCVA. [ Time Frame: Weeks 12, 28 and 52. ] [ Designated as safety issue: No ]
  • Gain of ≥ 0 letters of BCVA. [ Time Frame: Weeks 12, 28 and 52. ] [ Designated as safety issue: No ]
  • Time from mandatory injection at Day 0 to the first PRN injection. [ Time Frame: To Be Determined ] [ Designated as safety issue: No ]
  • Total number of Lucentis® injections during the first 12, 28, and 104 weeks. [ Time Frame: Week 12, 28, and 104 ] [ Designated as safety issue: No ]
  • Change in total lesion and CNV size. [ Time Frame: Week 12, 28 and 52. ] [ Designated as safety issue: No ]

Estimated Enrollment: 210
Study Start Date: November 2009
Estimated Study Completion Date: May 2013
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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.
  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 ClinicalTrials.gov identifier: NCT01016873

Locations
Austria
LKH Graz
Graz, Austria, A-8036
Universitätsklinik Innsbruck
Innsbruck, Austria, A-6020
Ordination Prof. Michael Stur
Wien, Austria, A-1180
Hanusch Krankenhaus Wien
Wien, Austria, A-1140
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
Military Hospital Prague
Prague, Czech Republic, 169 02
Faculty Hospital Kralovske Vinohrady
Prague, Czech Republic, 100 34
General Faculty Hospital Prague
Prague, Czech Republic, 128 08
Germany
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
Italy
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.
Investigators
Study Director: Denis O'Shaughnessy, Ph.D. Oraya Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: Oraya Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01016873     History of Changes
Other Study ID Numbers: CLH002
Study First Received: November 19, 2009
Last Updated: June 12, 2012
Health Authority: Austria: Agency for Health and Food Safety
Austria: Ethikkommission
Czech Republic: Ethics Committee
Germany: Ethics Commission
Germany: Federal Office for Radiation Protection
Germany: Ministry of Health
Italy: Ethics Committee
United Kingdom: Research Ethics Committee

Keywords provided by Oraya Therapeutics, Inc.:
Macular Degeneration
Oraya
Oraya Therapeutics, Inc.
low voltage stereotactic radiotherapy
radiotherapy
IRay
Ranibizumab
Lucentis
AMD
xray
radiation
x ray
external beam radiation
radiosurgery

Additional relevant MeSH terms:
Macular Degeneration
Choroidal Neovascularization
Eye Diseases
Retinal Diseases
Retinal Degeneration
Choroid Diseases
Uveal Diseases
Neovascularization, Pathologic
Metaplasia
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014