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

Primary Purpose

AMD, Wet AMD, Age-Related Macular Degeneration

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
IRay
Sponsored by
Oraya Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for AMD focused on measuring Oraya, Oraya Therapeutics, Inc., low voltage stereotactic radiotherapy, radiotherapy, IRay, Ranibizumab, Lucentis, AMD, Macular Degeneration, xray, radiation, x ray, external beam radiation, radiosurgery

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • LKH Graz
  • Universitätsklinik Innsbruck
  • Hanusch Krankenhaus Wien
  • Ordination Prof. Michael Stur
  • Fakultni Nemocnice Brno
  • Fakultni nemocnice Hradec Kralove
  • Fakultni Nemocnice Olomouc
  • Faculty Hospital Kralovske Vinohrady
  • General Faculty Hospital Prague
  • Military Hospital Prague
  • Kopfklinikum University Hospital Heidelberg
  • University Eye Hospital
  • Klinik für Augenheilkunde
  • Università Vita-Salute Istituto Scientifico San Raffaele
  • Royal Victoria Hospital
  • Bradford Royal Infirmary
  • Torbay Hospital
  • King's College
  • Manchester Royal Eye Hospital
  • Southampton General Hospital
  • Royal Wolverhampton Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Sham Comparator

Experimental

Sham Comparator

Arm Label

16 Gy IRay

Sham 16 Gy IRay

24 Gy IRay

Sham 24 Gy IRay

Arm Description

16 Gy IRay + PRN Lucentis®

Sham 16 Gy IRay + PRN Lucentis®

24 Gy IRay + PRN Lucentis®

Sham 24 Gy IRay + PRN Lucentis®

Outcomes

Primary Outcome Measures

Number of Lucentis® Injections Up To And Including Week 52

Secondary Outcome Measures

Change in Mean Visual Acuity (VA)
Percentage (Pct.) of Patients (Pts.) Losing < 15 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.)
Percentage (Pct.) of Patients (Pts.) Gaining ≥ 15 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.)
Percentage (Pct.) of Patients (Pts.) Gaining ≥ 0 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.)
Time From Mandatory Injection at Day 0 to the First PRN Injection.
Total Number (No.) of Lucentis® Injections (Inject.) During The First 12, 28, and 104 Weeks.
Mean Change in Choroidal Neovascularization (CNV) as % of Lesion on Fluorescein Angiography (FA) From Baseline to Week 52

Full Information

First Posted
November 19, 2009
Last Updated
December 1, 2014
Sponsor
Oraya Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01016873
Brief Title
INTREPID - IRay Plus Anti-VEGF Treatment For Patients With Wet AMD
Acronym
INTREPID
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)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oraya Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AMD, Wet AMD, Age-Related Macular Degeneration, Wet Age-Related Macular Degeneration, Macular Degeneration, Eye Diseases, Retinal Diseases
Keywords
Oraya, Oraya Therapeutics, Inc., low voltage stereotactic radiotherapy, radiotherapy, IRay, Ranibizumab, Lucentis, AMD, Macular Degeneration, xray, radiation, x ray, external beam radiation, radiosurgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
230 (Actual)

8. Arms, Groups, and Interventions

Arm Title
16 Gy IRay
Arm Type
Experimental
Arm Description
16 Gy IRay + PRN Lucentis®
Arm Title
Sham 16 Gy IRay
Arm Type
Sham Comparator
Arm Description
Sham 16 Gy IRay + PRN Lucentis®
Arm Title
24 Gy IRay
Arm Type
Experimental
Arm Description
24 Gy IRay + PRN Lucentis®
Arm Title
Sham 24 Gy IRay
Arm Type
Sham Comparator
Arm Description
Sham 24 Gy IRay + PRN Lucentis®
Intervention Type
Device
Intervention Name(s)
IRay
Intervention Description
Low voltage stereotactic radiotherapy system
Primary Outcome Measure Information:
Title
Number of Lucentis® Injections Up To And Including Week 52
Time Frame
During the first 52 weeks.
Secondary Outcome Measure Information:
Title
Change in Mean Visual Acuity (VA)
Time Frame
Weeks 12, 28, 52 and 104.
Title
Percentage (Pct.) of Patients (Pts.) Losing < 15 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.)
Time Frame
Weeks 12, 28 and 52.
Title
Percentage (Pct.) of Patients (Pts.) Gaining ≥ 15 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.)
Time Frame
Weeks 12, 28 and 52.
Title
Percentage (Pct.) of Patients (Pts.) Gaining ≥ 0 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.)
Time Frame
Weeks 12, 28 and 52.
Title
Time From Mandatory Injection at Day 0 to the First PRN Injection.
Time Frame
52 Weeks
Title
Total Number (No.) of Lucentis® Injections (Inject.) During The First 12, 28, and 104 Weeks.
Time Frame
Week 12, 28, and 104
Title
Mean Change in Choroidal Neovascularization (CNV) as % of Lesion on Fluorescein Angiography (FA) From Baseline to Week 52
Time Frame
Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denis O'Shaughnessy, Ph.D.
Organizational Affiliation
Oraya Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
LKH Graz
City
Graz
ZIP/Postal Code
A-8036
Country
Austria
Facility Name
Universitätsklinik Innsbruck
City
Innsbruck
ZIP/Postal Code
A-6020
Country
Austria
Facility Name
Hanusch Krankenhaus Wien
City
Wien
ZIP/Postal Code
A-1140
Country
Austria
Facility Name
Ordination Prof. Michael Stur
City
Wien
ZIP/Postal Code
A-1180
Country
Austria
Facility Name
Fakultni Nemocnice Brno
City
Brno
ZIP/Postal Code
625 00
Country
Czech Republic
Facility Name
Fakultni nemocnice Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czech Republic
Facility Name
Fakultni Nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
775 20
Country
Czech Republic
Facility Name
Faculty Hospital Kralovske Vinohrady
City
Prague
ZIP/Postal Code
100 34
Country
Czech Republic
Facility Name
General Faculty Hospital Prague
City
Prague
ZIP/Postal Code
128 08
Country
Czech Republic
Facility Name
Military Hospital Prague
City
Prague
ZIP/Postal Code
169 02
Country
Czech Republic
Facility Name
Kopfklinikum University Hospital Heidelberg
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
University Eye Hospital
City
Tübingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany
Facility Name
Klinik für Augenheilkunde
City
Neubrandenburg
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
17036
Country
Germany
Facility Name
Università Vita-Salute Istituto Scientifico San Raffaele
City
Milano
ZIP/Postal Code
I-20132
Country
Italy
Facility Name
Royal Victoria Hospital
City
Belfast
ZIP/Postal Code
BT12 6BA
Country
United Kingdom
Facility Name
Bradford Royal Infirmary
City
Bradford
ZIP/Postal Code
BDP 6RJ
Country
United Kingdom
Facility Name
Torbay Hospital
City
Devon
ZIP/Postal Code
TQ2 7AA
Country
United Kingdom
Facility Name
King's College
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Manchester Royal Eye Hospital
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Royal Wolverhampton Hospital NHS Foundation Trust
City
Wolverhampton
ZIP/Postal Code
WV3 9QR
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
32844399
Citation
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.
Results Reference
derived

Learn more about this trial

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

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