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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
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