Frontlight ResearchEarly access
CompletedPhase 3
A Study to Investigate Vamikibart in Participants With Uveitic Macular Edema
Key facts
- Who runs it
- Hoffmann-La Roche
- Where
- Austin, Bloomfield, Cleveland, Columbus, Dallas, Erie, Hagerstown, Lakewood, Los Angeles, Minneapolis, Nashville, Omaha, Portland, St. Petersburg, West Columbia, and Winston-Salem, United StatesSee the 16 sitesAlso in 13 other countries, 61 sites
- Trial code
- Status
- Completed
- Phase
- Phase 3
- People taking part
- 245 people enrolled
- Started
- 9 Jan 2023
- Ended
- 9 Jul 2025
- Type of study
- Interventional, 3 groupsOne group gets a sham (pretend) treatment, for comparison.
- Treatments tested
- Vamikibart
- Sham
- Record updated
- 21 November 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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
Who cannot take part
- Evidence of active or latent tuberculosis infection and/or positive tuberculosis assay, or previous or current HIV diagnosis
- 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
- Evidence of active or latent syphilis infection
- Serious acute or chronic medical or psychiatric illness
- History of major ocular and non-ocular surgical procedures
- Any major ocular conditions that may require medical or surgical intervention during the study period to prevent vision loss
- 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
- Diagnosis of macular edema due to any cause other than NIU
Where in United States
Also in 13 other countries, 61 sites
- Austin Clinical Research, LLCAustin, United States
- Envision Ocular, LLCBloomfield, United States
- University Hospitals Cleveland Medical Center*Cleveland, United States
- The Ohio State University Investigational Drug ServicesColumbus, United States
- Texas Retina AssociatesDallas, United States
- Erie Retina ResearchErie, United States
- Cumberland Valley Retina PCHagerstown, United States
- Colorado Retina Associates, PCLakewood, United States
- Kaiser Permanente Southern CaliforniaLos Angeles, United States
- VitreoRetinal Surgery, PLLC.Minneapolis, United States
- Tennessee Retina, PCNashville, United States
- Truhlsen Eye InstituteOmaha, United States
- Oregon Health & Science UniPortland, United States
- Retina Vitreous Associates of FloridaSt. Petersburg, United States
- Palmetto Retina CenterWest Columbia, United States
- Wake Forest Baptist Health Eye CentreWinston-Salem, United States
About the trial
What the trial wants to find out
This study will assess the efficacy and safety of vamikibart in participants with uveitic macular edema.
The 3 groups in the trial
- Arm ATreatment being tested
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.
Treatment: Vamikibart
- Arm BTreatment being tested
Participants will receive 4 low-dose vamikibart IVT injections Q4W to Week 12, followed by PRN dosing from Week 20 to Week 48.
Treatment: Vamikibart
- Arm CSham treatment, for comparison
Participants will receive 4 sham injections Q4W to Week 12, followed by PRN sham dosing from Week 20 to Week 48.
Treatment: Sham
Data and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A Phase III, Multicenter, Randomized, Double-Masked, Sham-Controlled Study to Investigate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Vamikibart Administered Intravitreally in Patients With Uveitic Macular Edema
- Record updated
- 21 November 2025