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

NCT ID: NCT01016873

Last Updated: 2014-12-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2014-04-30

Brief Summary

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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

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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.

Conditions

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AMD Wet AMD Age-Related Macular Degeneration Wet Age-Related Macular Degeneration Macular Degeneration Eye Diseases Retinal Diseases

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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16 Gy IRay

16 Gy IRay + PRN Lucentis®

Group Type EXPERIMENTAL

IRay

Intervention Type DEVICE

Low voltage stereotactic radiotherapy system

Sham 16 Gy IRay

Sham 16 Gy IRay + PRN Lucentis®

Group Type SHAM_COMPARATOR

IRay

Intervention Type DEVICE

Low voltage stereotactic radiotherapy system

24 Gy IRay

24 Gy IRay + PRN Lucentis®

Group Type EXPERIMENTAL

IRay

Intervention Type DEVICE

Low voltage stereotactic radiotherapy system

Sham 24 Gy IRay

Sham 24 Gy IRay + PRN Lucentis®

Group Type SHAM_COMPARATOR

IRay

Intervention Type DEVICE

Low voltage stereotactic radiotherapy system

Interventions

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IRay

Low voltage stereotactic radiotherapy system

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oraya Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Denis O'Shaughnessy, Ph.D.

Role: STUDY_DIRECTOR

Oraya Therapeutics, Inc.

Locations

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LKH Graz

Graz, , Austria

Site Status

Universitätsklinik Innsbruck

Innsbruck, , Austria

Site Status

Hanusch Krankenhaus Wien

Vienna, , Austria

Site Status

Ordination Prof. Michael Stur

Vienna, , Austria

Site Status

Fakultni Nemocnice Brno

Brno, , Czechia

Site Status

Fakultni nemocnice Hradec Kralove

Hradec Králové, , Czechia

Site Status

Fakultni Nemocnice Olomouc

Olomouc, , Czechia

Site Status

Faculty Hospital Kralovske Vinohrady

Prague, , Czechia

Site Status

General Faculty Hospital Prague

Prague, , Czechia

Site Status

Military Hospital Prague

Prague, , Czechia

Site Status

Kopfklinikum University Hospital Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Site Status

University Eye Hospital

Tübingen, Baden-Wurttemberg, Germany

Site Status

Klinik für Augenheilkunde

Neubrandenburg, Mecklenburg-Vorpommern, Germany

Site Status

Università Vita-Salute Istituto Scientifico San Raffaele

Milan, , Italy

Site Status

Royal Victoria Hospital

Belfast, , United Kingdom

Site Status

Bradford Royal Infirmary

Bradford, , United Kingdom

Site Status

Torbay Hospital

Devon, , United Kingdom

Site Status

King's College

London, , United Kingdom

Site Status

Manchester Royal Eye Hospital

Manchester, , United Kingdom

Site Status

Southampton General Hospital

Southampton, , United Kingdom

Site Status

Royal Wolverhampton Hospital NHS Foundation Trust

Wolverhampton, , United Kingdom

Site Status

Countries

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Austria Czechia Germany Italy United Kingdom

References

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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.

Reference Type DERIVED
PMID: 32844399 (View on PubMed)

Other Identifiers

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CLH002

Identifier Type: -

Identifier Source: org_study_id