Vamikibart in Participants With Uveitic Macular Edema

NCT05642325 | Completed Phase 3 DMC FDA Drug

• 2 other identifiers: GR442782022-501794-39-00
• Study Type: interventional
• Target: 256
• Locations: 19 countries
• Sites: 94

Brief Summary

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

Conditions

Uveitic Macular Edema

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with ≥ 15 letter improvement from baseline in best-corrected visual acuity (BCVA) at Week 16

  Week 16

Secondary Outcomes (21)

• Proportion of participants with ≥ 15 letter improvement from baseline in BCVA at Week 20

  Week 20

• Change from baseline in BCVA at Week 16

  Week 16

• Change from baseline in central subfield thickness (CST) at Week 16

  Week 16

• Change from Baseline in BCVA at Weeks 20 and 52

  Weeks 20 and 52

• Change from baseline in CST at Weeks 20 and 52

  Weeks 20 and 52

Study Arms (3)

Arm A

EXPERIMENTAL

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

Arm B

EXPERIMENTAL

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

Arm C

SHAM COMPARATOR

Participants will receive 4 sham injections Q4W to Week 12, followed by PRN sham dosing from Week 20 to Week 48.

Other: Sham

Interventions

Vamikibart DRUG

Participants will receive vamikibart IVT injection

Also known as: RO7200220

Arm A; Arm B

Sham OTHER

Participants will receive a sham procedure that mimics an IVT injection.

Arm C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (94)

Associated Retina Consultants

Phoenix, Arizona, 85020, United States

Location

Barnet Dulaney Perkins Eye Center

Sun City, Arizona, 85351, United States

Location

Retina Consultants of Orange County

Fullerton, California, 92835, United States

Location

Northern California Retina Vitreous Associates

Mountain View, California, 94040, United States

Location

California Eye Specialists Medical group Inc.

Pasadena, California, 91107, United States

Location

Retina Consultants of Southern California

Redlands, California, 92374, United States

Location

Kaiser Permanente Riverside Medical Center

Riverside, California, 92505, United States

Location

University of California, Davis, Eye Center

Sacramento, California, 95817, United States

Location

Retinal Consultants Med Group

Sacramento, California, 95825, United States

Location

Advanced Research

Deerfield Beach, Florida, 33064, United States

Location

Retina Group of Florida

Fort Lauderdale, Florida, 33308, United States

Location

University Retina and Macula Associates, PC

Oak Forest, Illinois, 60452, United States

Location

Cumberland Valley Retina PC

Hagerstown, Maryland, 21740, United States

Location

University of Michigan, Kellogg Eye Center

Ann Arbor, Michigan, 48105, United States

Location

Duke Eye Center

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Erie Retina Research

Erie, Pennsylvania, 16507-1429, United States

Location

Mid Atlantic Retina

Philadelphia, Pennsylvania, 19107, United States

Location

Retina Research Institute of Texas

Abilene, Texas, 79606, United States

Location

Retina Consultants of Texas

Bellaire, Texas, 77401, United States

Location

Retina Consultants of Texas

Katy, Texas, 77494, United States

Location

Retina Group of Washington

Fairfax, Virginia, 22031, United States

Location

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

Centro Privado de Ojos

Ciudad Autonoma Buenos Aires, C1033AAW, Argentina

Location

Buenos Aires Mácula

Ciudad Autonoma Buenos Aires, C1061AAE, Argentina

Location

Consultorios Medicos Oftalmológicos

Ciudad Autonoma Buenos Aires, C1426DQS, Argentina

Location

Oftalmologia Global

Rosario, 2000, Argentina

Location

Organizacion Medica de Investigacion

San Nicolás, C1015ABO, Argentina

Location

Sydney Eye Hospital

Sydney, New South Wales, 2000, Australia

Location

Centre For Eye Research Australia

East Melbourne, Victoria, 3002, Australia

Location

Eye Surgery Associates

Malvern, Victoria, 3144, Australia

Location

Retina Specialists Victoria

Rowville, Victoria, 3178, Australia

Location

The Lions Eye Institute

Nedlands, Western Australia, 6009, Australia

Location

Peking Union Medical College Hospital

Beijing, 100032, China

Location

Beijing Tongren Hospital

Beijing, 100730, China

Location

The First Affiliated Hospital, Chongqing Medical University

Chongqing, 400016, China

Location

General Teaching Hospital Prague

Prague, 128 08, Czechia

Location

CHU Nantes - Hotel Dieu

Nantes, 44093, France

Location

Hopital Lariboisiere

Paris, 75010, France

Location

Hôpital COCHIN

Paris, 75014, France

Location

Ch Pitie Salpetriere

Paris, 75651, France

Location

Charité-Universitätsmedizin Berlin, Campus Virchow Klinikum

Berlin, 13353, Germany

Location

Universitatsklinikum Koln

Cologne, 50937, Germany

Location

Universitätsklinikum Freiburg, Klinik für Augenheilkunde

Freiburg im Breisgau, 79106, Germany

Location

Universitätsmedizin Göttingen Georg-August-Universität

Göttingen, 37075, Germany

Location

Universitatsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Universitätsklinik Heidelberg

Heidelberg, 69120, Germany

Location

Universitätskliniikum Schleswig-Holstein, Campus Lübeck

Lübeck, 23538, Germany

Location

St. Franziskus Hospital

Münster, 48145, Germany

Location

Knappschaftsklinikum Saar GmbH

Sulzbach, 66280, Germany

Location

Universitäts-Augenklinik Tübingen

Tübingen, 72076, Germany

Location

Narayana Nethralaya Hospital

Bangalore, Karnataka, 560010, India

Location

Sankara Nethralaya

Chennai, Tamil Nadu, 600006, India

Location

L V Prasad Eye Institute

Hyderabad, Telangana, 500034, India

Location

ICARE Eye Hospital & PG Institute

Noida, Uttar Pradesh, 201301, India

Location

Postgraduate Institute of Medical Education and Research

Chandigarh, 160012, India

Location

AUSL ? IRCCS Santa Maria Nuova

Reggio Emilia, Emilia-Romagna, 42100, Italy

Location

Irccs Ospedale San Raffaele

Milan, Lombardy, 20132, Italy

Location

Asst Fatebenefratelli Sacco

Milan, Lombardy, 20157, Italy

Location

Kyushu University Hospital

Fukuoka, 812-8582, Japan

Location

Hiroshima University Hospital

Hiroshima, 734-8551, Japan

Location

Hokkaido University Hospital

Hokkaido, 060-8648, Japan

Location

Kobe University Hospital

Hyōgo, 650-0017, Japan

Location

Kagoshima University Hospital

Kagoshima, 890-8520, Japan

Location

Yokohama City University Hospital

Kanagawa, 236-0004, Japan

Location

Japan Community Health care Organization Osaka Hospital

Osaka, 553-0003, Japan

Location

The University of Osaka Hospital

Osaka, 565-0871, Japan

Location

Jichi Medical University Saitama Medical Center

Saitama, 330-0834, Japan

Location

National Defense Medical College Hospital

Saitama, 359-8513, Japan

Location

Tokyo Medical University Hospital

Tokyo, 160-0023, Japan

Location

Kyorin University Hospital

Tokyo, 181-8611, Japan

Location

Nippon Medical School Tama Nagayama Hospital

Tokyo, 206-8512, Japan

Location

Yamaguchi University Hospital

Yamaguchi, 755-8505, Japan

Location

"Kazakh "Badge of H?nour" Scientific R?s??r?h Institute of ??? diseases" LLP

Almaty, 050012, Kazakhstan

Location

AIBILI - Association for Innovation and Biomedical Research on Light

Coimbra, 3000-548, Portugal

Location

Hospital de Santa Maria

Lisbon, 1649-035, Portugal

Location

National University Hospital

Singapore, 119074, Singapore

Location

Pusan National University Hospital

Busan, 602-739, South Korea

Location

Kyung Hee University Hospital

Seoul, 02447, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 8907, Spain

Location

Hospital de Cruces

Barakaldo, Vizcaya, 48903, Spain

Location

Hospital Clinic Barcelona

Barcelona, 08036, Spain

Location

Fundacion Jimenez Diaz-UTE

Madrid, 28040, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Inselspital Bern Ophthalmologische Klinik

Bern, 3010, Switzerland

Location

Berner Augenklinik

Bern, Switzerland

Location

Vista Klinik Ophthalmologische Klinik

Binningen, 4102, Switzerland

Location

Stadtspital Triemli Ophthalmologische Klinik

Zurich, 8063, Switzerland

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Chang Gung Medical Foundation - Linkou

Taoyuan District, 333, Taiwan

Location

Hacettepe University Medical Faculty

Ankara, 06100, Turkey (Türkiye)

Location

Ege Üniversitesi Tip Fakültesi

Lzmir, 35100, Turkey (Türkiye)

Location

Moorfields Eye Hospital NHS Foundation Trust

London, EC1V 2PD, United Kingdom

Location

MeSH Terms

Interventions

salicylhydroxamic acid

Study Officials

• Clinical Trials

  Hoffmann-LaRoche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: December 8, 2022
• Study Start: March 23, 2023
• Primary Completion: May 7, 2025
• Study Completion: December 24, 2025
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

TU (2); CH (4); TW (2); SG (1); JP (14); CN (3); AR (5); CZ (1); IN (5); US (23); IT (3); GB (1); PT (2); ES (5); KA (1); DE (10); AU (5); KR (3); FR (4)