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.
Who Can Participate?
Eligibility
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.
- 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 Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
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.
- 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.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
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
STUDY TO INVESTIGATE THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF RO7200220 ADMINISTERED INTRAVITREALLY IN PATIENTS WITH UVEITIC MACULAR EDEMA - GR44278 Sandcat
Principal Investigator
Amol
Sura
Protocol Number
PRO00112314
NCT ID
NCT05151731
Phase
III
Enrollment Status
INSTITUTIONAL APPROVAL SIGNOFF