A Study to Investigate Vamikibart in Participants With Uveitic Macular Edema (Meerkat)

November 19, 2025 updated by: Hoffmann-La Roche

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

245

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • LKH-Univ.Klinikum Graz
      • Linz, Austria, 4021
        • Kepler Universitätskliniken GmbH - Med Campus III
      • Vienna, Austria, 1090
        • Medizinische Universität Wien
  • Brazil
      • Rio de Janeiro, Brazil, 21040-360
        • Fiocruz - Fundação Oswaldo Cruz
    • São Paulo
      • São Paulo, São Paulo, Brazil, 04023-062
        • Universidade Federal de Sao Paulo - UNIFESPX
      • São Paulo, São Paulo, Brazil, 01427-002
        • Retina Clinic
      • São Paulo, São Paulo, Brazil, 04084-002
        • CEMAPE - Centro Médico
  • Canada
      • Québec, Canada, G1S 4L8
        • CHU de Quebec-Universite Laval
    • Ontario
      • Toronto, Ontario, Canada, M5T 3A9
        • Kensington Vision and Research Centre
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Hôpital Maisonneuve - Rosemont
  • China
      • Beijing, China, 100032
        • Peking Union Medical College Hospital
      • Beijing, China, 100730
        • Beijing Tongren Hospital
      • Changchun, China, 130041
        • The Second Hospital of Jilin University
      • Chongqing, China, 400016
        • The First Affiliated Hospital, Chongqing Medical University
      • Guangzhou, China, 510060
        • Zhongshan Ophthalmic Center, Sun Yat-sen University
      • Hangzhou, China
        • Second Affiliated Hospital Zhejiang University College of Medicine
      • Shanghai, China, 200080
        • Shanghai First People's Hospital
      • Tianjin, China, 300070
        • Tianjin Medical University Eye Hospital
      • Wenzhou, China, 325027
        • Eye Hospital, Wenzhou Medical University
      • Wuhan, China, 430060
        • Ren Min Hospital Affiliated Wu Han University
  • Israel
      • Haifa, Israel, 3109601
        • Rambam Medical Center
      • Jerusalem, Israel, 9112001
        • Hadassah MC
      • Kfar Saba, Israel, 4428164
        • Meir Medical Center
      • Petah Tikva, Israel, 4941492
        • Rabin MC
      • Rehovot, Israel, 7660101
        • Kaplan Medical Center
      • Tel Aviv, Israel, 6423906
        • Tel Aviv Sourasky MC
      • Tel Aviv, Israel, 6789140
        • Assuta Hashalom Medical Center
  • Italy
    • Emilia-Romagna
      • Reggio Emilia, Emilia-Romagna, Italy, 42100
        • AUSL ? IRCCS Santa Maria Nuova
    • Liguria
      • Rapallo, Liguria, Italy, 16035
        • ASL 4 SSR Ospedale Santa Maria di Montallegro
    • Lombardy
      • Milan, Lombardy, Italy, 20132
        • IRCCS Ospedale San Raffaele
      • Milan, Lombardy, Italy, 20157
        • Asst Fatebenefratelli Sacco
  • Mexico
    • Mexico CITY (federal District)
      • Mexico City, Mexico CITY (federal District), Mexico, 04030
        • Hospital de la Ceguera APEC
  • Netherlands
      • Rotterdam, Netherlands, 3011 BH
        • Het Oogziekenhuis Rotterdam
      • Utrecht, Netherlands, 3584 CX
        • Universitair Medisch Centrum Utrecht
  • Poland
      • Bydgoszcz, Poland, 85-631
        • OFTALMIKA Sp. z o.o
      • Katowice, Poland, 40-594
        • Gabinet Okulistyczny Prof Edward Wylegala
      • Krakow, Poland, 31-501
        • SP ZOZ Szpital Uniwersytecki w Krakowie Oddzia? Kliniczny Okulistyki i Onkologii Okulistycznej
      • Lublin, Poland, 20-079
        • SPSK nr 1 w Lublinie
      • Wroclaw, Poland, 53-334
        • SPEKTRUM Osrodek Okulistyki Klinicznej
  • Portugal
      • Coimbra, Portugal, 3000-548
        • AIBILI - Association for Innovation and Biomedical Research on Light
      • Lisbon, Portugal, 1649-035
        • Hospital de Santa Maria
      • Lisbon, Portugal, 1169-019
        • Instituto de Oftalmologia Dr. Gama Pinto
  • South Korea
      • Busan, South Korea, 49241
        • Pusan National University Hospital
      • Daegu, South Korea, 42415
        • Yeungnam University Medical Center
      • Gyeonggi-do, South Korea, 16499
        • Ajou University Medical Center
      • Seongnam-si, South Korea, 13605
        • Seoul National University Bundang Hospital
      • Seoul, South Korea, 05505
        • Asan Medical Center
      • Seoul, South Korea, 06351
        • Samsung Medical Center
      • Seoul, South Korea, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, South Korea, 07301
        • Kim's Eye Hospital
      • Seoul, South Korea, 06591
        • Seoul St Mary's Hospital
  • Taiwan
      • Taipei, Taiwan
        • Mackay Memorial Hospital
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taoyuan District, Taiwan, 333
        • Chang Gung Medical Foundation - Linkou
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Queen Elizabeth Hospital
      • Bradford, United Kingdom, BD9 6RJ
        • Bradford Royal Infirmary
      • Bristol, United Kingdom, BS1 2LX
        • Bristol Eye Hospital
      • Gloucestershire, United Kingdom, GL1 3NN
        • Gloucestershire Hospitals NHS Foundation Trust
      • Liverpool, United Kingdom, L7 8XP
        • Royal Liverpool University Hospital
      • London, United Kingdom, NW1 5QH
        • Western Eye Hospital
      • Middlesbrough, United Kingdom, TS4 3BW
        • James Cook Hospital
  • United States
    • California
      • Los Angeles, California, United States, 90027
        • Kaiser Permanente Southern California
    • Colorado
      • Lakewood, Colorado, United States, 80228
        • Colorado Retina Associates, PC
    • Florida
      • St. Petersburg, Florida, United States, 33711-1141
        • Retina Vitreous Associates of Florida
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Cumberland Valley Retina PC
    • Minnesota
      • Minneapolis, Minnesota, United States, 55435
        • VitreoRetinal Surgery, PLLC.
    • Nebraska
      • Omaha, Nebraska, United States, 68106-5540
        • Truhlsen Eye Institute
    • New Jersey
      • Bloomfield, New Jersey, United States, 07003
        • Envision Ocular, LLC
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Health Eye Centre
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
      • Columbus, Ohio, United States, 43212
        • The Ohio State University Investigational Drug Services
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science Uni
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16507-1429
        • Erie Retina Research
    • South Carolina
      • West Columbia, South Carolina, United States, 29169
        • Palmetto Retina Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Tennessee Retina PC
    • Texas
      • Austin, Texas, United States, 78750
        • Austin Clinical Research LLC
      • Dallas, Texas, United States, 75231
        • Texas Retina Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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
  • Any major ocular conditions that may require medical or surgical intervention during the study period to prevent vision loss

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Arm C
Participants will receive 4 sham injections Q4W to Week 12, followed by PRN sham dosing from Week 20 to Week 48.
Other: Sham
Participants will receive a sham procedure that mimics an IVT injection.
Experimental: Arm A
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.
Drug: Vamikibart
Participants will receive vamikibart IVT injection
Other Names:
  • RO7200220
Experimental: Arm B
Participants will receive 4 low-dose vamikibart IVT injections Q4W to Week 12, followed by PRN dosing from Week 20 to Week 48.
Drug: Vamikibart
Participants will receive vamikibart IVT injection
Other Names:
  • RO7200220

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of participants with ≥ 15 letter improvement from baseline in best-corrected visual acuity (BCVA) at Week 16
Time Frame: Week 16
Week 16

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of participants with ≥ 15 letter improvement from baseline in BCVA at Week 20
Time Frame: Week 20
Week 20
Change from baseline in BCVA at Week 16
Time Frame: Week 16
Week 16
Change from baseline in central subfield thickness (CST) at Week 16
Time Frame: Week 16
Week 16
Change from Baseline in BCVA at Weeks 20 and 52
Time Frame: Weeks 20 and 52
Weeks 20 and 52
Change from baseline in CST at Weeks 20 and 52
Time Frame: Weeks 20 and 52
Weeks 20 and 52
Proportion of participants with uveitic macular edema secondary to non-infectious uveitis (UME) resolution defined by standardized (by machine) CST threshold <325um on optical coherence tomography (OCT) from baseline at Weeks 16 and 52
Time Frame: Weeks 16 and 52
Weeks 16 and 52
Time to rescue treatment
Time Frame: Up to Week 52
Up to Week 52
Number of rescue treatments received
Time Frame: Up to Week 52
Up to Week 52
Type of rescue treatments received
Time Frame: Up to Week 52
Up to Week 52
Proportion of participants with ≥15 letter improvement from baseline in BCVA at Week 16 and 52
Time Frame: Weeks 16 and 52
Weeks 16 and 52
Proportion of participants without ≥15 letter loss from baseline in BCVA at Week 16 and 52
Time Frame: Weeks 16 and 52
Weeks 16 and 52
Time to first PRN injection
Time Frame: Up to Week 52
Up to Week 52
Change from baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) at Weeks 16 and 52
Time Frame: Weeks 16 and 52
Weeks 16 and 52
Percentage of participants with ocular adverse events (AEs)
Time Frame: Up to Week 52
Up to Week 52
Percent change from baseline in corneal endothelial cell density at Week 24
Time Frame: Week 24
Week 24
Percentage of participants with non-ocular AEs
Time Frame: Up to Week 52
Up to Week 52
Percentage of participants with adverse events of special interest (AESIs)
Time Frame: Up to Week 52
Up to Week 52
Percent change from baseline in corneal endothelial cell density at Week 52
Time Frame: Week 52
Week 52
Number of PRN injections received
Time Frame: Up to Week 52
Up to Week 52
Aqueous humor (AH) concentration of vamikibart
Time Frame: Up to Week 52
Up to Week 52
Serum concentration of vamikibart
Time Frame: Up to Week 52
Up to Week 52
Anti-drug antibody titer to vamikibart
Time Frame: Baseline to Week 52
Baseline to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2023

Primary Completion (Actual)

December 9, 2024

Study Completion (Actual)

July 9, 2025

Study Registration Dates

First Submitted

December 6, 2022

First Submitted That Met QC Criteria

December 6, 2022

First Posted (Actual)

December 8, 2022

Study Record Updates

Last Update Posted (Actual)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 19, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GR44277
  • 2022-501793-19-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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