This study will assess the efficacy and safety of vamikibart in participants with uveitic macular edema.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
245
Participants will receive vamikibart IVT injection
Participants will receive a sham procedure that mimics an IVT injection.
Proportion of participants with ≥ 15 letter improvement from baseline in best-corrected visual acuity (BCVA) at Week 16
Time frame: Week 16
Proportion of participants with ≥ 15 letter improvement from baseline in BCVA at Week 20
Time frame: Week 20
Change from baseline in BCVA at Week 16
Time frame: Week 16
Change from baseline in central subfield thickness (CST) at Week 16
Time frame: Week 16
Change from Baseline in BCVA at Weeks 20 and 52
Time frame: Weeks 20 and 52
Change from baseline in CST at Weeks 20 and 52
Time frame: Weeks 20 and 52
Proportion of participants with uveitic macular edema secondary to non-infectious uveitis (UME) resolution defined by standardized (by machine) CST threshold <325um on optical coherence tomography (OCT) from baseline at Weeks 16 and 52
Time frame: Weeks 16 and 52
Time to rescue treatment
Time frame: Up to Week 52
Number of rescue treatments received
Time frame: Up to Week 52
Type of rescue treatments received
Time frame: Up to Week 52
Proportion of participants with ≥15 letter improvement from baseline in BCVA at Week 16 and 52
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Kaiser Permanente Southern California
Los Angeles, California, United States
Colorado Retina Associates, PC
Lakewood, Colorado, United States
Retina Vitreous Associates of Florida
St. Petersburg, Florida, United States
Cumberland Valley Retina PC
Hagerstown, Maryland, United States
VitreoRetinal Surgery, PLLC.
Minneapolis, Minnesota, United States
Truhlsen Eye Institute
Omaha, Nebraska, United States
Envision Ocular, LLC
Bloomfield, New Jersey, United States
Wake Forest Baptist Health Eye Centre
Winston-Salem, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
The Ohio State University Investigational Drug Services
Columbus, Ohio, United States
...and 67 more locations
Time frame: Weeks 16 and 52
Proportion of participants without ≥15 letter loss from baseline in BCVA at Week 16 and 52
Time frame: Weeks 16 and 52
Number of PRN injections received
Time frame: Up to Week 52
Time to first PRN injection
Time frame: Up to Week 52
Change from baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) at Weeks 16 and 52
Time frame: Weeks 16 and 52
Percentage of participants with ocular adverse events (AEs)
Time frame: Up to Week 52
Percentage of participants with non-ocular AEs
Time frame: Up to Week 52
Percent change from baseline in corneal endothelial cell density at Week 24
Time frame: Week 24
Percentage of participants with adverse events of special interest (AESIs)
Time frame: Up to Week 52
Percent change from baseline in corneal endothelial cell density at Week 52
Time frame: Week 52
Aqueous humor (AH) concentration of vamikibart
Time frame: Up to Week 52
Serum concentration of vamikibart
Time frame: Up to Week 52
Anti-drug antibody titer to vamikibart
Time frame: Baseline to Week 52