UAMS - Translational Research Institute

Vamikibart in Participants With Uveitic Macular Edema

This study will assess the efficacy and safety of vamikibart in participants with uveitic macular edema.

Female participants: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception as defined by the protocol - Diagnosis of macular edema associated with non-infectious uveitis (NIU) - Diagnosis of active or inactive, acute, or chronic NIU of any etiology and of any anatomical type (anterior, intermediate, posterior, panuveitis) - BCVA letter score of 73 to 19 letters (inclusive) on Early Treatment Diabetic Retinopathy Study (EDTRS)-like charts

Evidence of active or latent syphilis infection - Evidence of active or latent tuberculosis infection and/or positive tuberculosis assay, or previous or current HIV diagnosis - Serious acute or chronic medical or psychiatric illness - History of major ocular and non-ocular surgical procedures - Uncontrolled IOP or glaucoma or chronic hypotony - Any anatomical changes or media opacity in the study eye preventing evaluation of retina, vitreous, and capture of study images - Prior use of IVT biologics including anti-VEGFs less than 2-4 months prior to Day 1; received IVT Methotrexate within 4 months prior to Day 1 - Prior macular laser therapy, cataract surgery within 6 months and laser capsulotomy within 3 months of Day 1 - Topical corticosteroids and/or topical NSAID > 3 drops per day in the 14 days prior to Day 1 (D1); intraocular or periocular corticosteroid injections in the 2 months prior to D1; subconjunctival corticosteroid injection within 1 month prior to Day 1; an OZURDEX implant in the 4 months prior to D1; YUTIQ, RETISERT or ILUVIEN implant in the 3 years prior to D1 - Diagnosis of macular edema due to any cause other than NIU - Any major ocular conditions that may require medical or surgical intervention during the study period to prevent vision loss

Arm	Description	Assigned Intervention
Experimental Arm A	Participants will receive 4 high-dose vamikibart intravitreal (IVT) injections every 4 weeks (Q4W) to Week 12, followed by as-needed (PRN) dosing from Week 20 to Week 48.	Drug: Vamikibart Participants will receive vamikibart IVT injection Other names: RO7200220
Experimental Arm B	Participants will receive 4 low-dose vamikibart IVT injections Q4W to Week 12, followed by PRN dosing from Week 20 to Week 48.	Drug: Vamikibart Participants will receive vamikibart IVT injection Other names: RO7200220
Sham Comparator Arm C	Participants will receive 4 sham injections Q4W to Week 12, followed by PRN sham dosing from Week 20 to Week 48.	Other: Sham Participants will receive a sham procedure that mimics an IVT injection.