PeriOcular and INTravitreal Corticosteroids for Uveitic Macular Edema Trial

PHASE3CompletedINTERVENTIONAL
Enrollment

192

Participants

Timeline

Start Date

June 16, 2015

Primary Completion Date

August 30, 2017

Study Completion Date

January 4, 2018

Conditions
Macular EdemaUveitis
Interventions
DRUG

Periocular triamcinolone 40 mg

Periocular triamcinolone acetonide, 40 mg injection may be given either by posterior sub-Tenon's approach or by the orbital floor approach, as both appear to have similar efficacy; the approach to the periocular injection will be recorded for analysis if needed.

DRUG

Intravitreal triamcinolone 4 mg

Intravitreal triamcinolone acetonide, 4 mg injection procedures should be carried out under controlled aseptic conditions which include the use of sterile gloves and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide such as betadine, applied to the periocular skin, eyelid and ocular surface are required prior to an intravitreal injection.

DRUG

Dexamethasone intravitreal implant

• Standard preparation as described for intravitreal injections.

Trial Locations (26)

10016

New York Eye and Ear Infirmary, New York

15213

Unniversity of Pittsburgh Medical Center, Pittsburgh

19104

Scheie Eye Institute, University of Pennsylvania, Philadelphia

19107

Wills Eye Hospital, Philadelphia

20892

National Eye Institute, NIH, Bethesda

21287

Johns Hopkins University, Baltimore

27710

Duke Eye Center, Duke University, Durham

30322

Emory University, Atlanta

33136

Anne Bates Leach Eye Hospital, University of Miami Miller School of Medicine, Miami

33612

University of South Florida, Tampa

48105

Kellogg Eye Center, University of Michigan, Ann Arbor

52242

University of Iowa, Iowa City

55905

MAYO Clinic, Rochester

60611

Northwestern University, Chicago

60612

Rush University Medical Center, Chicago

63110

Washington University School of Medicine, St Louis

77030

Vitreoretinal Consultants, Houston

84132

John A. Moran Eye Center, University of Utah, Salt Lake City

90095

Jules Stein Eye Institute, UCLA, Los Angeles

94143

University of California, San Francisco, San Francisco

98104

University of Washington, Seattle

02114

Massachusetts Eye and Ear Infirmary, Boston

Ophthalmic Consultants of Boston, Boston

Unknown

Royal Victorian Eye & Ear Hospital, East Melbourne

H4A 3s5

McGill University, Montreal

EC1V 9EL

Moorfields Eye Hospital, London

All Listed Sponsors
collaborator

National Eye Institute (NEI)

NIH

lead

JHSPH Center for Clinical Trials

OTHER