The purpose of this Phase 1, first in uveitis open-label study is to assess the safety and tolerability of TRX-103 in patients with non infectious uveitis (NIU). It is anticipated that up to 18 Subjects will be enrolled during a 18-24 month enrollment period. TRX-103 will be infused one time.
≥ 18 to ≤ 70 years of age at time of consent.
Weight of ≥ 40 kg at time of consent.
Subjects must be able to understand and sign informed consent and be willing and able to complete all specified procedures and visits.
.≥ 2+ VH (NEI/SUN Scale) OR
Any condition preventing evaluation/assessment of both eyes.
Any significant ocular disease that could compromise vision.
Proliferative or severe non-proliferative diabetic retinopathy or clinically significant macular edema due to non-uveitis causes.
Isolated anterior uveitis.
Quan Dong Nguyen
Lead sponsor
Stanford University
Sponsor institution