Suprachoroidal Injection of Triamcinolone Acetonide With IVT Anti-VEGF in Subjects With Macular Edema Following RVO
NCT ID: NCT03203447
Last Updated: 2021-04-23
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
325 participants
INTERVENTIONAL
2018-03-05
2018-12-18
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
Lucentis (0.5 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection or Avastin (1.25 mg/0.05 mL), IVT injection + CLS-TA (4 mg/0.10 mL), SC injection
suprachoroidal CLS-TA
suprachoroidal injection of CLS-TA
Lucentis or Avastin
IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin
Control
Lucentis (0.5 mg/0.05 mL), IVT injection + sham SC procedure or Avastin (1.25 mg/0.05 mL), IVT injection + sham SC procedure
suprachoroidal sham
sham suprachoroidal procedure
Lucentis or Avastin
IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin
Interventions
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suprachoroidal CLS-TA
suprachoroidal injection of CLS-TA
suprachoroidal sham
sham suprachoroidal procedure
Lucentis or Avastin
IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin
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
Role: STUDY_DIRECTOR
Chief Medical Officer
Locations
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Retinal Research Institute
Phoenix, Arizona, United States
Retina Centers PC
Tucson, Arizona, United States
Retina Associates Southwest PC
Tucson, Arizona, United States
Win Retina
Arcadia, California, United States
Retina Vitreous Medical Group
Beverly Hills, California, United States
Retinal Diagnostic Center
Campbell, California, United States
Retina Consultants of Orange County
Fullerton, California, United States
Macula and Retina Institute
Glendale, California, United States
American Institute of Research
Los Angeles, California, United States
Retina Vitreous Associates Medical Group Inc
Mountain View, California, United States
Stanford University - Byers Eye Institute
Palo Alto, California, United States
Retina Consultants of Southern California
Redlands, California, United States
Retina Consultants Medical Group Inc
Sacramento, California, United States
American Institute of Research
Whittier, California, United States
Retina Group of New England, PC
New London, Connecticut, United States
Florida Eye Microsurgical Institute
Boynton Beach, Florida, United States
Specialty Retina Center
Coral Springs, Florida, United States
National Ophthalmic Research Institute
Fort Myers, Florida, United States
Center for Retina Care at The Eye Institute
Melbourne, Florida, United States
Florida Retina Institute
Orlando, Florida, United States
Eye Associates of Pinellas
Pinellas Park, Florida, United States
Retina Vitreous Associates of Florida
St. Petersburg, Florida, United States
East Florida Eye Institute EFEI
Stuart, Florida, United States
Southern Vitreoretinal Association
Tallahassee, Florida, United States
Center for Retina And Macular Disease
Winter Haven, Florida, United States
Retina Consultants of Hawaii
‘Aiea, Hawaii, United States
Gailey Eye Clinic
Bloomington, Illinois, United States
University and Macula Associates
Oak Forest, Illinois, United States
Prairie Eye Center, Ltd.
Springfield, Illinois, United States
Sabates Eye Centers
Leawood, Kansas, United States
Vitreo-Retinal Consultants and Surgeons PA
Wichita, Kansas, United States
Central Plains Eye MDs
Wichita, Kansas, United States
Paducah Retinal Center
Paducah, Kentucky, United States
Retina Specialists
Baltimore, Maryland, United States
The Retina Care Center
Baltimore, Maryland, United States
Retina Group of Washington
Chevy Chase, Maryland, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States
The National Retina Institute
Towson, Maryland, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States
New England Retina Consultants
Springfield, Massachusetts, United States
Associated Retinal Consultants PC
Grand Rapids, Michigan, United States
Vitreo-Retinal Associates, P.C.
Grand Rapids, Michigan, United States
Associated Retinal Consultants P.C.
Royal Oak, Michigan, United States
Retina Consultants of Michigan
Southfield, Michigan, United States
Associated Retinal Consultants PC
Traverse City, Michigan, United States
Retina Associates of St. Louis
Florissant, Missouri, United States
Retina Consultants of Nevada
Las Vegas, Nevada, United States
Sierra Eye Associates
Reno, Nevada, United States
Ophthalmic Consultants of Long Island
Lynbrook, New York, United States
Retina Associates of Western New York
Rochester, New York, United States
Island Retina
Shirley, New York, United States
Retina-Vitreous Surgeons of Central New York
Syracuse, New York, United States
Retina Associates of Cleveland Inc
Middleburg Heights, Ohio, United States
Dean A. McGee Eye Institute
Oklahoma City, Oklahoma, United States
Pennsylvania Retina Specialists PC
Camp Hill, Pennsylvania, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States
Texas Retina Associates - Arlington
Arlington, Texas, United States
Austin Retina Associates
Austin, Texas, United States
Retina Research Center
Austin, Texas, United States
Texas Retina Associates
Dallas, Texas, United States
Retina and Vitreous of Texas, PLLC
Houston, Texas, United States
Retina Consultants of Houston, PA
Houston, Texas, United States
Valley Retina Institute, PA
McAllen, Texas, United States
Retina Specialists
Plano, Texas, United States
San Antonio Eye Center
San Antonio, Texas, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, United States
Retina Associates of South Texas PA
San Antonio, Texas, United States
Retina Consultants of Houston, PA
The Woodlands, Texas, United States
Strategic Clinical Research Group, LLC
Willow Park, Texas, United States
Rocky Mountain Retina Consultants
Salt Lake City, Utah, United States
Retina Group of Washington
Fairfax, Virginia, United States
West Virginia University Medicine Eye Institute
Morgantown, West Virginia, United States
Eye Clinic Albury Wodonga
Albury, New South Wales, Australia
Strathfield Retina Clinic
Strathfield, New South Wales, Australia
Save Sight Institute, University of Sydney (Sydney Eye Hospital)
Sydney, New South Wales, Australia
MH EK Honvédkórház
Budapest, , Hungary
Raghudeep Eye Hospital
Gujrāt, Ahmedabad, India
LV Prasad Eye Institute
Hyderabad, Andhra Pradesh, India
L V Prasad Eye Institute
Visakhapatnam, Andhra Pradesh, India
R.P. Centre, AIIMS
New Delhi, Ansari Nagar, India
Narayana Nethralaya
RajajiNagar, Bangalaore, India
LV Prasad Eye Institute
Patia, Bhubaneswar, India
M&J Western Regional Institute of Ophthalmology
Asarwa, Gujarat, India
PBMA's H.V Desai Eye Hospital
Pune, Maharashtra, India
Dr Shroff 's Charity Eye Hospital
Delhi, New Delhi, India
Regional Institute of Ophthalmology
Bīhar, Patna, India
B B Eye Foundation VIP
Kolkata, Raghunathpur, India
SMS Hospital
Jaipur, Rajasthan, India
Aravind Eye Hospital
Madurai, Tamil Nadu, India
Jawaharlal Rohatgi Eye Hospital
Kanpur, Uttar Pradesh, India
Disha Eye Hospitals Pvt. Ltd.
Kolkata, West Bengal, India
Auckland Eye
Auckland, , New Zealand
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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CLS1003-302
Identifier Type: -
Identifier Source: org_study_id
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