A Study to Investigate Vamikibart in Participants With Uveitic Macular Edema

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

NCT05642312•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•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
+1 more criteria

Locations (77)

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

Key Dates

Start Date

January 9, 2023

Primary Completion Date

December 9, 2024

Completion Date

July 9, 2025

Last Updated

November 21, 2025

Enrollment

245

ACTUAL participants

Conditions

Uveitic Macular Edema

Interventions

Vamikibart

DRUG

Sham

OTHER