Macular Edema Ranibizumab v. Intravitreal Anti-inflammatory Therapy Trial

PHASE3CompletedINTERVENTIONAL
Enrollment

194

Participants

Timeline

Start Date

March 9, 2017

Primary Completion Date

October 27, 2021

Study Completion Date

February 2, 2022

Conditions
UveitisMacular Edema
Interventions
DRUG

Dexamethasone intravitreal implant 0.7 mg

Standard preparation as described for intravitreal injections.

DRUG

Intravitreal Methotrexate 400 µg

Intravitreal Methotrexate 400 µg 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 the injection.

DRUG

Intravitreal Ranibizumab 0.5 mg

Intravitreal Ranibizumab 0.5 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 the injection.

Trial Locations (33)

15213

University of Pittsburgh Medical Center, Pittsburgh

19104

Scheie Eye Institute, University of Pennsylvania, Philadelphia

19107

MidAtlanitc Retina, Wills Eye Hospital, Philadelphia

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

37232

Vanderbilt, Nashville

40202

University of Louisville, Louisville

48105

Kellogg Eye Center, University of Michigan, Ann Arbor

52242

University of Iowa, Iowa City

60611

Northwestern University, Chicago

60612

Rush University Medical Center, Chicago

77030

Retinal Consultants of Houston, 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

500034

LV Prasad Eye Institute - Hyderabad, Hyderabad

02114

Massachusetts Eye and Ear Infirmary, Boston

Ophthalmic Consultants of Boston, Boston

Unknown

Royal Victorian Eye and Ear Hospital, East Melbourne

LV Prasad Eye Institute - Bhubaneswar, Bhubaneswar

Medical and Vision Research Foundation, Chennai

Advanced Eye Center, Post Graduate Institute of Medical Education and Research, Chandigarh

H4A 3S5

McGill University, Montreal

BS1 2LX

University Hospitals Bristol NHS Foundation Trust, Bristol

CB2 0QQ

Cambridge University Hospitals NHS Foundation Trust, Cambridge

LE1 5WW

University Hospitals of Leicester NHS Trust, Leicester

L7 8XP

Liverpool University Hospitals NHS Foundation Trust, Liverpool

EC1V 2PD

Moorfields Eye Hospital NHS Foundation Trust, London

M13 (WL

Manchester University NHS Foundation Trust, Manchester

B152WB

University Hospitals Birmingham NHS Foundation Trust, Birmingham

EC1V 9EL

Moorfields Eye Hospital, London

All Listed Sponsors
collaborator

National Eye Institute (NEI)

NIH

lead

JHSPH Center for Clinical Trials

OTHER