Suprachoroidal Injection of Triamcinolone Acetonide With IVT Aflibercept in Subjects With Macular Edema Following RVO
NCT ID: NCT02980874
Last Updated: 2021-04-14
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
460 participants
INTERVENTIONAL
2017-01-31
2018-12-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Active
IVT aflibercept (2 mg/0.05 mL) + CLS-TA (4 mg/100 µL) SC injections
suprachoroidal CLS-TA
suprachoroidal injection of CLS-TA
IVT aflibercept
2 mg intravitreal injection of aflibercept
Control
IVT aflibercept (2 mg/0.05 mL) + sham SC procedure
suprachoroidal sham
suprachoroidal sham procedure
IVT aflibercept
2 mg intravitreal injection of aflibercept
Interventions
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suprachoroidal CLS-TA
suprachoroidal injection of CLS-TA
suprachoroidal sham
suprachoroidal sham procedure
IVT aflibercept
2 mg intravitreal injection of aflibercept
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Clearside Biomedical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas Ciulla, MD MBA
Role: STUDY_DIRECTOR
Clearside Biomedical, Inc.
Locations
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Associated Retina Consultants, Ltd.
Peoria, Arizona, United States
Retinal Consultants of Arizona and Retinal Research Institute
Phoenix, Arizona, United States
Arizona Retina and Vitreous Consultants
Phoenix, Arizona, United States
Associated Retina Consultants, Ltd.
Phoenix, Arizona, United States
Retina Centers P.C.
Tucson, Arizona, United States
California Retina Research Consultants
Bakersfield, California, United States
Retina Vitreous Medical Group Clinical Research
Beverly Hills, California, United States
Atlantis Eyecare
Huntington Beach, California, United States
Jacobs Retina Center at the Shiley Eye Institute, UCSD
La Jolla, California, United States
Northern California Retina Vitreous Associates
Mountain View, California, United States
East Bay Retina Consultants Inc.
Oakland, California, United States
Southern California Desert Retina Consultants
Palm Desert, California, United States
Retina Institute of California
Palm Desert, California, United States
Retina Consultants San Diego
Poway, California, United States
Orange County Retina Medical Group
Santa Ana, California, United States
California Retina Consultants CRC
Santa Barbara, California, United States
Bay Area Retina Associates
Walnut Creek, California, United States
Colorado Retina Associates
Golden, Colorado, United States
New England Retina Associates
Hamden, Connecticut, United States
MedEye Associates
Miami, Florida, United States
Retina Specialty Institute
Pensacola, Florida, United States
Sarasota Retina Institute
Sarasota, Florida, United States
Retina Vitreous Associates of Florida
St. Petersburg, Florida, United States
Center for Retina and Macular Disease
Winter Haven, Florida, United States
Emory Eye Center
Atlanta, Georgia, United States
Southeast Retina Center, PC
Augusta, Georgia, United States
Marietta Eye Clinic
Marietta, Georgia, United States
Retina Consultants of Hawaii
‘Aiea, Hawaii, United States
Illinois Eye and Ear Infirmary, UIC
Chicago, Illinois, United States
Illinois Retina Associates
Chicago, Illinois, United States
Carle Foundation Hospital
Urbana, Illinois, United States
Midwest Eye Institute
Indianapolis, Indiana, United States
Retina Associates, PA
Shawnee Mission, Kansas, United States
Retina and Vitrous Associates of Kentucky
Lexington, Kentucky, United States
Wilmer Eye Institute John Hopkins University
Baltimore, Maryland, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States
The Retina Institute
St Louis, Missouri, United States
Retina Associates of NJ
Teaneck, New Jersey, United States
Western Carolina Retinal Associates, PA
Asheville, North Carolina, United States
Cincinnati Eye Institute
Cincinnati, Ohio, United States
Cleveland Clinic Foundation/Cole Eye Institute
Cleveland, Ohio, United States
Oregon Retina Institute
Medford, Oregon, United States
Casey Eye Institute/Oregon Health & Science University
Portland, Oregon, United States
Eye Care Specialists
Kingston, Pennsylvania, United States
Wills Eye Hospital
Philadelphia, Pennsylvania, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States
Retina Research Institute of Texas
Abilene, Texas, United States
Texas Retina Associates-Arlington
Arlington, Texas, United States
Austin Retina Associates
Austin, Texas, United States
Texas Retina Associates
Dallas, Texas, United States
Retina Consultants of Houston
Houston, Texas, United States
Valley Retina Institute
McAllen, Texas, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, United States
Retina Consultants of Houston
The Woodlands, Texas, United States
University of Utah HSC - John A. Moran Eye Center
Salt Lake City, Utah, United States
Retina Institute of Virginia
Richmond, Virginia, United States
Virginia Retina Center
Warrenton, Virginia, United States
University of Wisconsin-Madison
Madison, Wisconsin, United States
Strathfield Retina Clinic
Strathfield, 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, Australia
Marsden Eye Specialists
Sydney, New South Wales, Australia
The Royal Victorian Eye and Ear Hospital
East Melbourne, Victoria, Australia
Specialist Eye Group
Melbourne, Victoria, Australia
University of Graz-Department of Ophthalmology
Graz, , Austria
Kepler University Hospital
Linz, , Austria
UBC/VGH Eye Care Centre
Vancouver, British Columbia, Canada
St. Joseph's Health Care London, Ivey Eye Institute
London, Ontario, Canada
University of Ottawa Eye Institute
Ottawa, Ontario, Canada
Institut de l'oeil des Laurentides
Boisbriand, Quebec, Canada
CIUSSS de l'Est-de-l'Ile-de-Montreal. Hospital Maisonneuve-Rosemont, Comite d'ethique de la recherche
Montreal, Quebec, Canada
Rigshospitalet
Glostrup Municipality, , Denmark
Dept. of Ophthalmology, Sjællands Universitetshospital, Roskilde
Roskilde, , Denmark
Semmelweis Egyetem, Szemeszeti Klinika
Budapest, , Hungary
Bajcsy-Zsilinszky Korhaz es Rendelointezet, Szemeszeti Osztaly
Budapest, , Hungary
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest, , Hungary
Budapest Retina Associates
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont, Szemklinika
Debrecen, , Hungary
Ganglion Orvosi Kozpont
Pécs, , Hungary
M&J Western Regional Institute of Ophthalmology
Ahmedabad, Gujarat, India
T.N. Medical College and B.Y.L. Nair Charitable Hospital
Mumbai, Maharashtra, India
Department of Medical Ophthalmology, Retina & Uvea
Delhi, New Delhi, India
Aravind Eye Hospitals & Postgraduate Institute of Ophthalmology
Madurai, Tamil Nadu, India
Smt. Kanuri Santhamma Centre for Vitreo Retinal Diseases
Hyderabad, Telangana, India
Disha Eye Hospital Private Limited
Kolkata, West Bengal, India
Bnai Zion Medical Center
Haifa, , Israel
ASST Fatebenefratelli Sacco - P.O.L., University of Milan, Dep. of Ophthalmology
Milan, , Italy
Cebu Doctor's University Hospital
Cebu City, , Philippines
Peregrine Eye & Laser Institute
Makati City, , Philippines
The Medical City
Pasig, , Philippines
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, , Poland
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, , Portugal
Fakultna nemocnica s poliklinikou Zilina
Žilina, , Slovakia
Instituto Cinico Quirurgico de Oftalmologia
Bilbao, Vizcaya, Spain
Hospital General de Catalunya
Barcelona, , Spain
Hospital Universitari de Bellvitge
Barcelona, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Instituto Oftalmologico Fernandez-Vega
Oviedo, , Spain
Clinica Universidad de Navarra
Pamplona, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Hospital Clinico Universitario
Zaragoza, , Spain
Kaohsiung Veterans General Hospital
Kaohsiung City, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Queens University Royal Victoria Hospital Trust
Belfast, , United Kingdom
Sunderland Eye Infirmary
Sunderland, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CLS1003-301
Identifier Type: -
Identifier Source: org_study_id
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