A Study to Investigate 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
- NCT05642312
- Run by
- Hoffmann-La Roche
- People needed
- 245
- Starts
- 2023-01-09
- Expected to finish
- 2025-07-09
- Last updated by the study team
- 2025-11-21
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
- 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
- Oregon Health & Science Uni — Portland, Oregon, United States
- Erie Retina Research — Erie, Pennsylvania, United States
- Palmetto Retina Center — West Columbia, South Carolina, United States
- Tennessee Retina PC — Nashville, Tennessee, United States
- Austin Clinical Research LLC — Austin, Texas, United States
- Texas Retina Associates — Dallas, Texas, United States
- LKH-Univ.Klinikum Graz — Graz, Austria
- Kepler Universitätskliniken GmbH - Med Campus III — Linz, Austria
- Medizinische Universitat Wien — Vienna, Austria
- Retina Clinic — São Paulo, São Paulo, Brazil
- Universidade Federal de Sao Paulo - UNIFESPX — São Paulo, São Paulo, Brazil
- CEMAPE - Centro Médico — São Paulo, São Paulo, Brazil
- Fiocruz - Fundação Oswaldo Cruz — Rio de Janeiro, Brazil
- Kensington Vision and Research Centre — Toronto, Ontario, Canada
- Tel Aviv Sourasky MC — Tel Aviv, Israel
Full record on ClinicalTrials.gov
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