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

Phase 2

Completed

• Conditions: Macular Degeneration; Eye Diseases; Wet Age-Related Macular Degeneration; Retinal Diseases; Wet AMD; Age-Related Macular Degeneration; AMD
• Interventions: Device: IRay

• Registration Number: NCT01016873
• Lead Sponsor: Oraya Therapeutics, Inc.

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.

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-19
• Study First Submitted QC: 2009-11-19
• Study First Posted: 2009-11-20
• Primary Completion: 2012-05
• Study Completion: 2014-04
• Results First Submitted: 2014-11-13
• Status Verified: 2014-12
• Results First Submitted QC: 2014-12-01
• Last Update Submitted: 2014-12-01
• Results First Posted: 2014-12-05
• Last Update Posted: 2014-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
24 Gy IRay	IRay	24 Gy IRay + PRN Lucentis®
Sham 24 Gy IRay	IRay	Sham 24 Gy IRay + PRN Lucentis®
16 Gy IRay	IRay	16 Gy IRay + PRN Lucentis®
Sham 16 Gy IRay	IRay	Sham 16 Gy IRay + PRN Lucentis®

Primary Outcome Measures

Name	Time	Method
Number of Lucentis® Injections Up To And Including Week 52	During the first 52 weeks.

Secondary Outcome Measures

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

Trial Locations

Locations (21)

Royal Victoria Hospital; 🇬🇧 Belfast, United Kingdom

Torbay Hospital; 🇬🇧 Devon, United Kingdom

King's College; 🇬🇧 London, United Kingdom

Bradford Royal Infirmary; 🇬🇧 Bradford, United Kingdom

Manchester Royal Eye Hospital; 🇬🇧 Manchester, United Kingdom

Southampton General Hospital; 🇬🇧 Southampton, United Kingdom

Royal Wolverhampton Hospital NHS Foundation Trust; 🇬🇧 Wolverhampton, United Kingdom

LKH Graz; 🇦🇹 Graz, Austria

Universitätsklinik Innsbruck; 🇦🇹 Innsbruck, Austria

Hanusch Krankenhaus Wien; 🇦🇹 Wien, Austria

Ordination Prof. Michael Stur; 🇦🇹 Wien, Austria

Fakultni Nemocnice Brno; 🇨🇿 Brno, Czech Republic

Fakultni nemocnice Hradec Kralove; 🇨🇿 Hradec Kralove, Czech Republic

General Faculty Hospital Prague; 🇨🇿 Prague, Czech Republic

Military Hospital Prague; 🇨🇿 Prague, Czech Republic

Kopfklinikum University Hospital Heidelberg; 🇩🇪 Heidelberg, Baden-Württemberg, Germany

University Eye Hospital; 🇩🇪 Tübingen, Baden-Württemberg, Germany

Klinik für Augenheilkunde; 🇩🇪 Neubrandenburg, Mecklenburg-Vorpommern, Germany

Fakultni Nemocnice Olomouc; 🇨🇿 Olomouc, Czech Republic

Faculty Hospital Kralovske Vinohrady; 🇨🇿 Prague, Czech Republic

Università Vita-Salute Istituto Scientifico San Raffaele; 🇮🇹 Milano, Italy