Suprachoroidal Injection of Triamcinolone Acetonide With IVT Aflibercept in Subjects With Macular Edema Following RVO



Status:Terminated
Conditions:Cardiology, Ocular, Ocular
Therapuetic Areas:Cardiology / Vascular Diseases, Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:1/11/2019
Start Date:January 31, 2017
End Date:December 10, 2018

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SAPPHIRE: 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

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

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

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
We found this trial at
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Pensacola, Florida 32503
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98-1079 Moanalua Road
'Aiea, Hawaii 96701
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Arlington, Texas 76012
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Asheville, North Carolina 28803
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Atlanta, Georgia 30322
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Augusta, Georgia 30909
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Austin, Texas 78705
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5555 Business Park South
Bakersfield, California 93309
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9001 Wilshire Boulevard
Beverly Hills, California 90211
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1855 West Taylor Street
Chicago, Illinois 60612
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2845 North Sheridan Road
Chicago, Illinois 60657
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Cincinnati, Ohio 45242
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Dallas, Texas 75231
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Golden, Colorado 80401
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Hagerstown, Maryland 21740
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Hamden, Connecticut 06518
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Houston, Texas 77030
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7677 Center Avenue
Huntington Beach, California 92647
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Indianapolis, Indiana 46290
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Kingston, Pennsylvania 18704
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9415 Campus Point Drive
La Jolla, California 92093
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120 North Eagle Creek Drive
Lexington, Kentucky 40509
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Madison, Wisconsin 53706
(608) 263-2400
University of Wisconsin-Madison In achievement and prestige, the University of Wisconsin-Madison has long been recognized...
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Marietta, Georgia 30060
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McAllen, Texas 78503
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1518 East Barnett Road
Medford, Oregon 97504
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Miami, Florida 33143
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Mountain View, California 94040
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Oakland, California 94609
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Palm Desert, California 92260
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Palm Desert, California 92211
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15353 North 91st Avenue
Peoria, Arizona 85381
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Philadelphia, Pennsylvania 19107
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1101 East Missouri Avenue
Phoenix, Arizona 85014
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Phoenix, Arizona 85020
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Poway, California 92064
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Rapid City, South Dakota 57701
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Richmond, Virginia
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Saint Louis, Missouri 63110
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4344 Central Avenue North
Saint Petersburg, Florida 33711
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San Antonio, Texas 78240
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Santa Ana, California 92705
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525 East Micheltorena Street
Santa Barbara, California 93103
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Sarasota, Florida 34239
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Shawnee Mission, Kansas 66204
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9-13 Redmyre Road
Strathfield, New South Wales 2135
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628 Cedar Lane
Teaneck, New Jersey 07666
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The Woodlands, Texas 77384
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Tucson, Arizona 85704
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Urbana, Illinois 61801
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Winter Haven, Florida 33880
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