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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02980874
Other study ID # CLS1003-301
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date January 31, 2017
Est. completion date December 10, 2018

Study information

Verified date March 2021
Source Clearside Biomedical, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a Phase 3, multicenter, randomized, masked, controlled, parallel group study of 12 months duration in treatment naïve subjects with RVO.


Description:

A randomized, masked, controlled trial to study the safety and efficacy of suprachoroidal CLS-TA in conjunction with intravitreal aflibercept in subjects with retinal vein occlusion


Recruitment information / eligibility

Status Terminated
Enrollment 460
Est. completion date December 10, 2018
Est. primary completion date December 10, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Has a clinical diagnosis of RVO in the study eye - Has a CST of = 300 µm in the study eye - Has an ETDRS BCVA score of = 20 letters read and = 70 letters read in the study eye; - Is naïve to local pharmacologic treatment for RVO in the study eye; Exclusion Criteria: - Any active ocular disease or infection in the study eye other than RVO - History of glaucoma, intraocular pressure > 21 mmHg or ocular hypertension requiring more than one medication - Any uncontrolled systemic disease that, in the opinion of the Investigator, would preclude participation in the study - Any evidence of neovascularization in the study eye

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
suprachoroidal CLS-TA
suprachoroidal injection of CLS-TA
suprachoroidal sham
suprachoroidal sham procedure
IVT aflibercept
2 mg intravitreal injection of aflibercept

Locations

Country Name City State
Australia The Royal Victorian Eye and Ear Hospital East Melbourne Victoria
Australia Specialist Eye Group Melbourne Victoria
Australia Strathfield Retina Clinic Strathfield New South Wales
Australia Marsden Eye Specialists Sydney New South Wales
Australia Save Site Institute, University of Sydney, Sydney Eye Hospital Sydney New South Wales
Australia Sydney Retina Clinic and Day Surgery Sydney New South Wales
Austria University of Graz-Department of Ophthalmology Graz
Austria Kepler University Hospital Linz
Canada Institut de l'oeil des Laurentides Boisbriand Quebec
Canada St. Joseph's Health Care London, Ivey Eye Institute London Ontario
Canada CIUSSS de l'Est-de-l'Ile-de-Montreal. Hospital Maisonneuve-Rosemont, Comite d'ethique de la recherche Montréal Quebec
Canada University of Ottawa Eye Institute Ottawa Ontario
Canada UBC/VGH Eye Care Centre Vancouver British Columbia
Denmark Rigshospitalet Glostrup
Denmark Dept. of Ophthalmology, Sjællands Universitetshospital, Roskilde Roskilde
Hungary Bajcsy-Zsilinszky Korhaz es Rendelointezet, Szemeszeti Osztaly Budapest
Hungary Budapest Retina Associates Budapest
Hungary Magyar Honvedseg Egeszsegugyi Kozpont Budapest
Hungary Semmelweis Egyetem, Szemeszeti Klinika Budapest
Hungary Debreceni Egyetem Klinikai Kozpont, Szemklinika Debrecen
Hungary Ganglion Orvosi Kozpont Pecs
India M&J Western Regional Institute of Ophthalmology Ahmedabad Gujarat
India Department of Medical Ophthalmology, Retina & Uvea Delhi New Delhi
India Smt. Kanuri Santhamma Centre for Vitreo Retinal Diseases Hyderabad Telangana
India Disha Eye Hospital Private Limited Kolkata West Bengal
India Aravind Eye Hospitals & Postgraduate Institute of Ophthalmology Madurai Tamil Nadu
India T.N. Medical College and B.Y.L. Nair Charitable Hospital Mumbai Maharashtra
Israel Bnai Zion Medical Center Haifa
Italy ASST Fatebenefratelli Sacco - P.O.L., University of Milan, Dep. of Ophthalmology Milan
Philippines Cebu Doctor's University Hospital Cebu City
Philippines Peregrine Eye & Laser Institute Makati City
Philippines The Medical City Pasig City
Poland Oftalmika sp. z o. o. Bydgoszcz
Poland Optimum Profesorskie Centrum Okulistyki Gdansk
Poland Uniwersytet Medyczny w Lublinie Lublin
Poland Centrum Diagnostyki i Mikrochirurgii Oka Lens Olsztyn
Portugal Centro Clinico Academico Braga - 2CA-Braga Braga
Portugal Centro Hospitalar e Universitario de Coimbra, E.P.E. Coimbra
Portugal Centro Hospitalar de Sao Joao, E.P.E. Porto
Slovakia Fakultna nemocnica s poliklinikou Zilina Žilina
Spain Hospital General de Catalunya Barcelona
Spain Hospital Universitari de Bellvitge Barcelona
Spain Instituto Cinico Quirurgico de Oftalmologia Bilbao Vizcaya
Spain Hospital Clinico San Carlos Madrid
Spain Instituto Oftalmologico Fernandez-Vega Oviedo
Spain Clinica Universidad de Navarra Pamplona
Spain Hospital Clinico Universitario Zaragoza
Spain Hospital Universitario Miguel Servet Zaragoza
Taiwan Kaohsiung Veterans General Hospital Kaohsiung
Taiwan Taipei Veterans General Hospital Taipei
United Kingdom Queens University Royal Victoria Hospital Trust Belfast
United Kingdom Sunderland Eye Infirmary Sunderland
United States Retina Consultants of Hawaii 'Aiea Hawaii
United States Retina Research Institute of Texas Abilene Texas
United States Texas Retina Associates-Arlington Arlington Texas
United States Western Carolina Retinal Associates, PA Asheville North Carolina
United States Emory Eye Center Atlanta Georgia
United States Southeast Retina Center, PC Augusta Georgia
United States Austin Retina Associates Austin Texas
United States California Retina Research Consultants Bakersfield California
United States Wilmer Eye Institute John Hopkins University Baltimore Maryland
United States Retina Vitreous Medical Group Clinical Research Beverly Hills California
United States Illinois Eye and Ear Infirmary, UIC Chicago Illinois
United States Illinois Retina Associates Chicago Illinois
United States Cincinnati Eye Institute Cincinnati Ohio
United States Cleveland Clinic Foundation/Cole Eye Institute Cleveland Ohio
United States Texas Retina Associates Dallas Texas
United States Colorado Retina Associates Golden Colorado
United States Cumberland Valley Retina Consultants Hagerstown Maryland
United States New England Retina Associates Hamden Connecticut
United States Retina Consultants of Houston Houston Texas
United States Atlantis Eyecare Huntington Beach California
United States Midwest Eye Institute Indianapolis Indiana
United States Eye Care Specialists Kingston Pennsylvania
United States Jacobs Retina Center at the Shiley Eye Institute, UCSD La Jolla California
United States Retina and Vitrous Associates of Kentucky Lexington Kentucky
United States University of Wisconsin-Madison Madison Wisconsin
United States Marietta Eye Clinic Marietta Georgia
United States Valley Retina Institute McAllen Texas
United States Oregon Retina Institute Medford Oregon
United States MedEye Associates Miami Florida
United States Northern California Retina Vitreous Associates Mountain View California
United States East Bay Retina Consultants Inc. Oakland California
United States Retina Institute of California Palm Desert California
United States Southern California Desert Retina Consultants Palm Desert California
United States Retina Specialty Institute Pensacola Florida
United States Associated Retina Consultants, Ltd. Peoria Arizona
United States Wills Eye Hospital Philadelphia Pennsylvania
United States Arizona Retina and Vitreous Consultants Phoenix Arizona
United States Associated Retina Consultants, Ltd. Phoenix Arizona
United States Retinal Consultants of Arizona and Retinal Research Institute Phoenix Arizona
United States Casey Eye Institute/Oregon Health & Science University Portland Oregon
United States Retina Consultants San Diego Poway California
United States Black Hills Regional Eye Institute Rapid City South Dakota
United States Retina Institute of Virginia Richmond Virginia
United States The Retina Institute Saint Louis Missouri
United States Retina Vitreous Associates of Florida Saint Petersburg Florida
United States University of Utah HSC - John A. Moran Eye Center Salt Lake City Utah
United States Medical Center Ophthalmology Associates San Antonio Texas
United States Orange County Retina Medical Group Santa Ana California
United States California Retina Consultants CRC Santa Barbara California
United States Sarasota Retina Institute Sarasota Florida
United States Retina Associates, PA Shawnee Mission Kansas
United States Retina Associates of NJ Teaneck New Jersey
United States Retina Consultants of Houston The Woodlands Texas
United States Retina Centers P.C. Tucson Arizona
United States Carle Foundation Hospital Urbana Illinois
United States Bay Area Retina Associates Walnut Creek California
United States Virginia Retina Center Warrenton Virginia
United States Center for Retina and Macular Disease Winter Haven Florida

Sponsors (1)

Lead Sponsor Collaborator
Clearside Biomedical, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,  Denmark,  Hungary,  India,  Israel,  Italy,  Philippines,  Poland,  Portugal,  Slovakia,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of Subjects Demonstrating = 15 Letter Improvement From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS) Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement. 2 months
Secondary Mean Change From Baseline in Best Corrected Visual Acuity Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. A positive change from baseline value represents an improvement in vision. 6 months
Secondary Mean Change From Baseline in Central Subfield Thickness Central subfield thickness (CST) is a diagnostic measurement used in identifying the presence of edema in the circular area 1 mm in diameter centered around the fovea. CST was measured using spectral domain optical coherence tomography (SD-OCT). A masked reading center graded the SD-OCT digital images. A negative change from baseline value represents a reduction in macular edema. 6 months
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