Vamikibart in Participants With Uveitic Macular Edema

Completed · Phase 3 · Has a placebo group

Conditions studied: Uveitic Macular Edema

In brief

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

Key facts

Study ID

NCT05642325

Run by

Hoffmann-La Roche

People needed

256

Starts

2023-03-23

Expected to finish

2025-12-24

Last updated by the study team

2026-04-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Retina Group of Florida — Fort Lauderdale, Florida, United States
• University Retina and Macula Associates, PC — Oak Forest, Illinois, United States
• Cumberland Valley Retina PC — Hagerstown, Maryland, United States
• University of Michigan, Kellogg Eye Center — Ann Arbor, Michigan, United States
• Duke Eye Center — Durham, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Erie Retina Research — Erie, Pennsylvania, United States
• Mid Atlantic Retina — Philadelphia, Pennsylvania, United States
• Retina Research Institute of Texas — Abilene, Texas, United States
• Retina Consultants of Texas — Bellaire, Texas, United States
• Retina Consultants of Texas — Katy, Texas, United States
• Retina Group of Washington — Fairfax, Virginia, United States
• University of Wisconsin — Madison, Wisconsin, United States
• Centro Privado de Ojos — Ciudad Autonoma Buenos Aires, Argentina
• Buenos Aires Mácula — Ciudad Autonoma Buenos Aires, Argentina
• Associated Retina Consultants — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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