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

Age-Related Macular Degeneration Clinical Trial

— INTREPID  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01016873
• Other study ID #: CLH002
• 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 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

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

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• AMD
• Choroidal Neovascularization
• Eye Diseases
• Macular Degeneration
• Retinal Diseases
• Wet Age-Related Macular Degeneration
• Wet AMD

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

External Links

•   Click here to learn about this and other studies being conducted at Oraya Therapeutics, Inc.