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

December 1, 2014 updated by: Oraya Therapeutics, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

230

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Lucentis® Injections Up To And Including Week 52
Time Frame: During the first 52 weeks.
During the first 52 weeks.

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Mean Visual Acuity (VA)
Time Frame: Weeks 12, 28, 52 and 104.
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.
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.
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.
Weeks 12, 28 and 52.
Time From Mandatory Injection at Day 0 to the First PRN Injection.
Time Frame: 52 Weeks
52 Weeks
Total Number (No.) of Lucentis® Injections (Inject.) During The First 12, 28, and 104 Weeks.
Time Frame: Week 12, 28, and 104
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
Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oraya Therapeutics, Inc.

Investigators

  • Study Director: Denis O'Shaughnessy, Ph.D., Oraya Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ACTUAL)

May 1, 2012

Study Completion (ACTUAL)

April 1, 2014

Study Registration Dates

First Submitted

November 19, 2009

First Submitted That Met QC Criteria

November 19, 2009

First Posted (ESTIMATE)

November 20, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

December 5, 2014

Last Update Submitted That Met QC Criteria

December 1, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLH002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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