A Study to Investigate Vamikibart in Participants With Uveitic Macular Edema

NCT05642312 | Completed Phase 3 DMC FDA Drug

• 2 other identifiers: GR442772022-501793-19-00
• Study Type: interventional
• Target: 245
• Locations: 14 countries
• Sites: 77

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 (22)

• 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 (77)

Kaiser Permanente Southern California

Los Angeles, California, 90027, United States

Location

Colorado Retina Associates, PC

Lakewood, Colorado, 80228, United States

Location

Retina Vitreous Associates of Florida

St. Petersburg, Florida, 33711-1141, United States

Location

Cumberland Valley Retina PC

Hagerstown, Maryland, 21740, United States

Location

VitreoRetinal Surgery, PLLC.

Minneapolis, Minnesota, 55435, United States

Location

Truhlsen Eye Institute

Omaha, Nebraska, 68106-5540, United States

Location

Envision Ocular, LLC

Bloomfield, New Jersey, 07003, United States

Location

Wake Forest Baptist Health Eye Centre

Winston-Salem, North Carolina, 27157, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

The Ohio State University Investigational Drug Services

Columbus, Ohio, 43212, United States

Location

Oregon Health & Science Uni

Portland, Oregon, 97239, United States

Location

Erie Retina Research

Erie, Pennsylvania, 16507-1429, United States

Location

Palmetto Retina Center

West Columbia, South Carolina, 29169, United States

Location

Tennessee Retina PC

Nashville, Tennessee, 37203, United States

Location

Austin Clinical Research LLC

Austin, Texas, 78750, United States

Location

Texas Retina Associates

Dallas, Texas, 75231, United States

Location

LKH-Univ.Klinikum Graz

Graz, 8036, Austria

Location

Kepler Universitätskliniken GmbH - Med Campus III

Linz, 4021, Austria

Location

Medizinische Universitat Wien

Vienna, 1090, Austria

Location

Retina Clinic

São Paulo, São Paulo, 01427-002, Brazil

Location

Universidade Federal de Sao Paulo - UNIFESPX

São Paulo, São Paulo, 04023-062, Brazil

Location

CEMAPE - Centro Médico

São Paulo, São Paulo, 04084-002, Brazil

Location

Fiocruz - Fundação Oswaldo Cruz

Rio de Janeiro, 21040-360, Brazil

Location

Kensington Vision and Research Centre

Toronto, Ontario, M5T 3A9, Canada

Location

Hôpital Maisonneuve - Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

CHU de Quebec-Universite Laval

Québec, G1S 4L8, Canada

Location

Peking Union Medical College Hospital

Beijing, 100032, China

Location

Beijing Tongren Hospital

Beijing, 100730, China

Location

The Second Hospital of Jilin University

Changchun, 130041, China

Location

The First Affiliated Hospital, Chongqing Medical University

Chongqing, 400016, China

Location

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, 510060, China

Location

Second Affiliated Hospital Zhejiang University College of Medicine

Hangzhou, China

Location

Shanghai First People's Hospital

Shanghai, 200080, China

Location

Tianjin Medical University Eye Hospital

Tianjin, 300070, China

Location

Eye Hospital, Wenzhou Medical University

Wenzhou, 325027, China

Location

Ren Min Hospital Affiliated Wu Han University

Wuhan, 430060, China

Location

Rambam Medical Center

Haifa, 3109601, Israel

Location

Hadassah MC

Jerusalem, 9112001, Israel

Location

Meir Medical Center

Kfar Saba, 4428164, Israel

Location

Rabin MC

Petah Tikva, 4941492, Israel

Location

Kaplan Medical Center

Rehovot, 7660101, Israel

Location

Tel Aviv Sourasky MC

Tel Aviv, 6423906, Israel

Location

Assuta Hashalom Medical Center

Tel Aviv, 6789140, Israel

Location

AUSL ? IRCCS Santa Maria Nuova

Reggio Emilia, Emilia-Romagna, 42100, Italy

Location

ASL 4 SSR Ospedale Santa Maria di Montallegro

Rapallo, Liguria, 16035, Italy

Location

Irccs Ospedale San Raffaele

Milan, Lombardy, 20132, Italy

Location

Asst Fatebenefratelli Sacco

Milan, Lombardy, 20157, Italy

Location

Hospital de la Ceguera APEC

Mexico City, Mexico CITY (federal District), 04030, Mexico

Location

Het Oogziekenhuis Rotterdam

Rotterdam, 3011 BH, Netherlands

Location

Universitair Medisch Centrum Utrecht

Utrecht, 3584 CX, Netherlands

Location

OFTALMIKA Sp. z o.o

Bydgoszcz, 85-631, Poland

Location

Gabinet Okulistyczny Prof Edward Wylegala

Katowice, 40-594, Poland

Location

SP ZOZ Szpital Uniwersytecki w Krakowie Oddzia? Kliniczny Okulistyki i Onkologii Okulistycznej

Krakow, 31-501, Poland

Location

SPSK nr 1 w Lublinie

Lublin, 20-079, Poland

Location

SPEKTRUM Osrodek Okulistyki Klinicznej

Wroclaw, 53-334, Poland

Location

AIBILI - Association for Innovation and Biomedical Research on Light

Coimbra, 3000-548, Portugal

Location

Instituto de Oftalmologia Dr. Gama Pinto

Lisbon, 1169-019, Portugal

Location

Hospital de Santa Maria

Lisbon, 1649-035, Portugal

Location

Pusan National University Hospital

Busan, 49241, South Korea

Location

Yeungnam University Medical Center

Daegu, 42415, South Korea

Location

Ajou University Medical Center

Gyeonggi-do, 16499, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, 13605, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Seoul St Mary's Hospital

Seoul, 06591, South Korea

Location

Kim's Eye Hospital

Seoul, 07301, South Korea

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Mackay Memorial Hospital

Taipei, Taiwan

Location

Chang Gung Medical Foundation - Linkou

Taoyuan District, 333, Taiwan

Location

Queen Elizabeth Hospital

Birmingham, B15 2TH, United Kingdom

Location

Bradford Royal Infirmary

Bradford, BD9 6RJ, United Kingdom

Location

Bristol Eye Hospital

Bristol, BS1 2LX, United Kingdom

Location

Gloucestershire Hospitals NHS Foundation Trust

Gloucestershire, GL1 3NN, United Kingdom

Location

Royal Liverpool University Hospital

Liverpool, L7 8XP, United Kingdom

Location

Western Eye Hospital

London, NW1 5QH, United Kingdom

Location

James Cook Hospital

Middlesbrough, TS4 3BW, United Kingdom

Location

MeSH Terms

Interventions

salicylhydroxamic acid

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  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: January 9, 2023
• Primary Completion: December 9, 2024
• Study Completion: July 9, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

TW (3); GB (7); BR (4); AU (3); IT (4); CA (3); US (16); PL (5); CN (10); KR (9); IL (7); NL (2); ME (1); PT (3)