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Sandcat GR44278 (Uveitic Macular Edema) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out the effects, good or bad, of an investigational drug called RO7200220 (the study drug) for participants with uveitic macular edema. This condition is caused by uveitis, and it is when fluid builds up in the retinal layers and causes swelling that can impair vision.

What is the Condition Being Studied?

Uveitic Macular Edema

Who Can Participate in the Study?

Adults ages 18+ who:

- Are diagnosed with Uveitic Macular Edema

- Are not pregnant, breastfeeding, or trying to become pregnant

- Do not have a serious acute or chronic medical illness that requires treatment

For more information about who can be in this study, please contact the study team at DEC-RA@duke.edu.

Age Group
Adults

What is Involved?

If you choose to join the study, you will:

- Get a random assignment (fair, equal chance) to 1 of 3 groups

-- Group A and B will both receive an injection of the study drug in the eye, but the doses will be different for these 2 groups

-- Group C will receive a sham procedure that feels like a real drug injection, but it does not involve a needle being inserted into the eye and nothing is injected into the eye

You will not know your group assignment until the study is over. After you receive your injection or sham procedure, you will visit our clinic up to 15 times over the course of about a year. During these visits, you will have blood draws, eye exams, vision tests, and answer some questionnaires.

Study Details

Full Title
A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-MASKED, SHAM-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF RO7200220 ADMINISTERED INTRAVITREALLY IN PATIENTS WITH UVEITIC MACULAR EDEMA - GR44278 Sandcat
Principal Investigator
Ophthalmologist
Protocol Number
IRB: PRO00112314
NCT: NCT05151731
Phase
Phase III
ClinicalTrials.gov
Enrollment Status
Open for Enrollment Soon