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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01016873
Other study ID # CLH002
Secondary ID
Status Completed
Phase Phase 2
First received November 19, 2009
Last updated December 1, 2014
Start date November 2009
Est. completion date April 2014

Study information

Verified date December 2014
Source Oraya Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority Austria: Agency for Health and Food SafetyAustria: EthikkommissionCzech Republic: Ethics CommitteeGermany: Ethics CommissionGermany: Federal Office for Radiation ProtectionGermany: Ministry of HealthItaly: Ethics CommitteeUnited Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 230
Est. completion date April 2014
Est. primary completion date May 2012
Accepts healthy volunteers No
Gender Both
Age group 50 Years and older
Eligibility Inclusion Criteria:

- Patients must have neovascular AMD diagnosed within the previous 3 years, have received at least 3 injections with LucentisĀ® or AvastinĀ® 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Device:
IRay
Low voltage stereotactic radiotherapy system

Locations

Country Name City State
Austria LKH Graz Graz
Austria Universitätsklinik Innsbruck Innsbruck
Austria Hanusch Krankenhaus Wien Wien
Austria Ordination Prof. Michael Stur Wien
Czech Republic Fakultni Nemocnice Brno Brno
Czech Republic Fakultni nemocnice Hradec Kralove Hradec Kralove
Czech Republic Fakultni Nemocnice Olomouc Olomouc
Czech Republic Faculty Hospital Kralovske Vinohrady Prague
Czech Republic General Faculty Hospital Prague Prague
Czech Republic Military Hospital Prague Prague
Germany Kopfklinikum University Hospital Heidelberg Heidelberg Baden-Württemberg
Germany Klinik für Augenheilkunde Neubrandenburg Mecklenburg-Vorpommern
Germany University Eye Hospital Tübingen Baden-Württemberg
Italy Università Vita-Salute Istituto Scientifico San Raffaele Milano
United Kingdom Royal Victoria Hospital Belfast
United Kingdom Bradford Royal Infirmary Bradford
United Kingdom Torbay Hospital Devon
United Kingdom King's College London
United Kingdom Manchester Royal Eye Hospital Manchester
United Kingdom Southampton General Hospital Southampton
United Kingdom Royal Wolverhampton Hospital NHS Foundation Trust Wolverhampton

Sponsors (1)

Lead Sponsor Collaborator
Oraya Therapeutics, Inc.

Countries where clinical trial is conducted

Austria,  Czech Republic,  Germany,  Italy,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Lucentis® Injections Up To And Including Week 52 During the first 52 weeks. No
Secondary Change in Mean Visual Acuity (VA) Weeks 12, 28, 52 and 104. No
Secondary Percentage (Pct.) of Patients (Pts.) Losing < 15 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.) Weeks 12, 28 and 52. No
Secondary Percentage (Pct.) of Patients (Pts.) Gaining = 15 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.) Weeks 12, 28 and 52. No
Secondary Percentage (Pct.) of Patients (Pts.) Gaining = 0 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.) Weeks 12, 28 and 52. No
Secondary Time From Mandatory Injection at Day 0 to the First PRN Injection. 52 Weeks No
Secondary Total Number (No.) of Lucentis® Injections (Inject.) During The First 12, 28, and 104 Weeks. Week 12, 28, and 104 No
Secondary Mean Change in Choroidal Neovascularization (CNV) as % of Lesion on Fluorescein Angiography (FA) From Baseline to Week 52 Week 52 No
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