Clinical trial NCT01016873: INTREPID - IRay Plus Anti-VEGF Treatment For Patients With Wet AMD
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: AMD
Wet AMD
Age-Related Macular Degeneration
Wet Age-Related Macular Degeneration
Macular Degeneration
Eye Diseases
Retinal Diseases
Keywords: Oraya
Oraya Therapeutics, Inc.
low voltage stereotactic radiotherapy
radiotherapy
IRay
Ranibizumab
Lucentis
AMD
Macular Degeneration
xray
radiation
x ray
external beam radiation
radiosurgery
Lead sponsor: Oraya Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2009-11-20
Enrollment: 230
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Lucentis® Injections Up To And Including Week 52
timeFrame: During the first 52 weeks.
Secondary outcomes:
measure: Change in Mean Visual Acuity (VA)
timeFrame: Weeks 12, 28, 52 and 104.
measure: Percentage (Pct.) of Patients (Pts.) Losing < 15 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.)
timeFrame: Weeks 12, 28 and 52.
measure: Percentage (Pct.) of Patients (Pts.) Gaining ≥ 15 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.)
timeFrame: Weeks 12, 28 and 52.
measure: Percentage (Pct.) of Patients (Pts.) Gaining ≥ 0 Letters of Best Correct Visual Acuity (BCVA) From Baseline (Base.)
timeFrame: Weeks 12, 28 and 52.
measure: Time From Mandatory Injection at Day 0 to the First PRN Injection.
timeFrame: 52 Weeks
measure: Total Number (No.) of Lucentis® Injections (Inject.) During The First 12, 28, and 104 Weeks.
timeFrame: Week 12, 28, and 104
measure: Mean Change in Choroidal Neovascularization (CNV) as % of Lesion on Fluorescein Angiography (FA) From Baseline to Week 52
timeFrame: Week 52
Other outcomes:
Locations:
city: Graz
country: Austria
facility: LKH Graz
city: Innsbruck
country: Austria
facility: Universitätsklinik Innsbruck
city: Wien
country: Austria
facility: Hanusch Krankenhaus Wien
city: Wien
country: Austria
facility: Ordination Prof. Michael Stur
city: Brno
country: Czech Republic
facility: Fakultni Nemocnice Brno
city: Hradec Kralove
country: Czech Republic
facility: Fakultni nemocnice Hradec Kralove
city: Olomouc
country: Czech Republic
facility: Fakultni Nemocnice Olomouc
city: Prague
country: Czech Republic
facility: Faculty Hospital Kralovske Vinohrady
city: Prague
country: Czech Republic
facility: General Faculty Hospital Prague
city: Prague
country: Czech Republic
facility: Military Hospital Prague
city: Heidelberg
country: Germany
facility: Kopfklinikum University Hospital Heidelberg
state: Baden-Württemberg
city: Tübingen
country: Germany
facility: University Eye Hospital
state: Baden-Württemberg
city: Neubrandenburg
country: Germany
facility: Klinik für Augenheilkunde
state: Mecklenburg-Vorpommern
city: Milano
country: Italy
facility: Università Vita-Salute Istituto Scientifico San Raffaele
city: Belfast
country: United Kingdom
facility: Royal Victoria Hospital
city: Bradford
country: United Kingdom
facility: Bradford Royal Infirmary
city: Devon
country: United Kingdom
facility: Torbay Hospital
city: London
country: United Kingdom
facility: King's College
city: Manchester
country: United Kingdom
facility: Manchester Royal Eye Hospital
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
city: Wolverhampton
country: United Kingdom
facility: Royal Wolverhampton Hospital NHS Foundation Trust
Study officials:
affiliation: Oraya Therapeutics, Inc.
name: Denis O'Shaughnessy, Ph.D.
role: STUDY_DIRECTOR
References:
citation: 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.