NCT01016873

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2009

Typical duration for phase_2

Geographic Reach
5 countries

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 20, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
8 months until next milestone

Results Posted

Study results publicly available

December 5, 2014

Completed
Last Updated

December 5, 2014

Status Verified

December 1, 2014

Enrollment Period

2.5 years

First QC Date

November 19, 2009

Results QC Date

November 13, 2014

Last Update Submit

December 1, 2014

Conditions

AMDWet AMDAge-Related Macular DegenerationWet Age-Related Macular DegenerationMacular DegenerationEye DiseasesRetinal Diseases

Keywords

OrayaOraya Therapeutics, Inc.low voltage stereotactic radiotherapyradiotherapyIRayRanibizumabLucentisAMDMacular Degenerationxrayradiationx rayexternal beam radiationradiosurgery

Outcome Measures

Primary Outcomes (1)

  • Number of Lucentis® Injections Up To And Including Week 52

    During the first 52 weeks.

Secondary Outcomes (7)

  • 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.

  • Percentage (Pct.) of Patients (Pts.) Gaining ≥ 15 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.)

    Weeks 12, 28 and 52.

  • Percentage (Pct.) of Patients (Pts.) Gaining ≥ 0 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

  • +2 more secondary outcomes

Study Arms (4)

16 Gy IRay

EXPERIMENTAL

16 Gy IRay + PRN Lucentis®

Device: IRay

Sham 16 Gy IRay

SHAM COMPARATOR

Sham 16 Gy IRay + PRN Lucentis®

Device: IRay

24 Gy IRay

EXPERIMENTAL

24 Gy IRay + PRN Lucentis®

Device: IRay

Sham 24 Gy IRay

SHAM COMPARATOR

Sham 24 Gy IRay + PRN Lucentis®

Device: IRay

Interventions

IRayDEVICE

Low voltage stereotactic radiotherapy system

16 Gy IRay24 Gy IRaySham 16 Gy IRaySham 24 Gy IRay

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

LKH Graz

Graz, A-8036, Austria

Location

Universitätsklinik Innsbruck

Innsbruck, A-6020, Austria

Location

Hanusch Krankenhaus Wien

Vienna, A-1140, Austria

Location

Ordination Prof. Michael Stur

Vienna, A-1180, Austria

Location

Fakultni Nemocnice Brno

Brno, 625 00, Czechia

Location

Fakultni nemocnice Hradec Kralove

Hradec Králové, 500 05, Czechia

Location

Fakultni Nemocnice Olomouc

Olomouc, 775 20, Czechia

Location

Faculty Hospital Kralovske Vinohrady

Prague, 100 34, Czechia

Location

General Faculty Hospital Prague

Prague, 128 08, Czechia

Location

Military Hospital Prague

Prague, 169 02, Czechia

Location

Kopfklinikum University Hospital Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

University Eye Hospital

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Klinik für Augenheilkunde

Neubrandenburg, Mecklenburg-Vorpommern, 17036, Germany

Location

Università Vita-Salute Istituto Scientifico San Raffaele

Milan, I-20132, Italy

Location

Royal Victoria Hospital

Belfast, BT12 6BA, United Kingdom

Location

Bradford Royal Infirmary

Bradford, BDP 6RJ, United Kingdom

Location

Torbay Hospital

Devon, TQ2 7AA, United Kingdom

Location

King's College

London, SE5 9RS, United Kingdom

Location

Manchester Royal Eye Hospital

Manchester, M13 9WL, United Kingdom

Location

Southampton General Hospital

Southampton, SO16 6YD, United Kingdom

Location

Royal Wolverhampton Hospital NHS Foundation Trust

Wolverhampton, WV3 9QR, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 32844399DERIVED

MeSH Terms

Conditions

Macular DegenerationEye DiseasesRetinal Diseases

Condition Hierarchy (Ancestors)

Retinal Degeneration

Results Point of Contact

Title
Denis O'Shaugnessy, Ph.D.
Organization
Oraya Therapeutics Inc.
doshaughnessy@orayainc.com
917-417-3974

Study Officials

  • Denis O'Shaughnessy, Ph.D.

    Oraya Therapeutics, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2009

First Posted

November 20, 2009

Study Start

November 1, 2009

Primary Completion

May 1, 2012

Study Completion

April 1, 2014

Last Updated

December 5, 2014

Results First Posted

December 5, 2014

Record last verified: 2014-12

Locations

GB(7)AU(4)CZ(6)DE(3)IT(1)