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
256
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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Associated Retina Consultants
Phoenix, Arizona, United States
Barnet Dulaney Perkins Eye Center
Sun City, Arizona, United States
Retina Consultants of Orange County
Fullerton, California, United States
Northern California Retina Vitreous Associates
Mountain View, California, United States
California Eye Specialists Medical group Inc.
Pasadena, California, United States
Retina Consultants of Southern California
Redlands, California, United States
Kaiser Permanente Riverside Medical Center
Riverside, California, United States
University of California, Davis, Eye Center
Sacramento, California, United States
Retinal Consultants Med Group
Sacramento, California, United States
Advanced Research
Deerfield Beach, Florida, United States
...and 84 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
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
Percent change from baseline in corneal endothelial cell density at Week 24
Time frame: Week 24
Percentage of participants with non-ocular AEs
Time frame: Up to Week 52
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