Age-Related Macular Degeneration Clinical Trial
— INTREPIDOfficial 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)
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.
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Oraya Therapeutics, Inc. |
Austria, Czech Republic, Germany, Italy, United Kingdom,
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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