A Study to Investigate Vamikibart in Participants With Uveitic Macular Edema
- Conditions
- Uveitic Macular Edema
- Interventions
- Other: Sham
- Registration Number
- NCT05642312
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This study will assess the efficacy and safety of vamikibart in participants with uveitic macular edema.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 245
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A Vamikibart 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. Arm B Vamikibart Participants will receive 4 low-dose vamikibart IVT injections Q4W to Week 12, followed by PRN dosing from Week 20 to Week 48. Arm C Sham Participants will receive 4 sham injections Q4W to Week 12, followed by PRN sham dosing from Week 20 to Week 48.
- Primary Outcome Measures
Name Time Method Proportion of participants with ≥ 15 letter improvement from baseline in best-corrected visual acuity (BCVA) at Week 16 Week 16
- Secondary Outcome Measures
Name Time Method Number of rescue treatments received Up to Week 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 Weeks 16 and 52 Proportion of participants with ≥15 letter improvement from baseline in BCVA at Week 16 and 52 Weeks 16 and 52 Proportion of participants without ≥15 letter loss from baseline in BCVA at Week 16 and 52 Weeks 16 and 52 Type of rescue treatments received Up to Week 52 Percentage of participants with non-ocular AEs Up to Week 52 Percent change from baseline in corneal endothelial cell density at Week 52 Week 52 Serum concentration of vamikibart Up to Week 52 Proportion of participants with ≥ 15 letter improvement from baseline in BCVA at Week 20 Week 20 Change from baseline in central subfield thickness (CST) at Week 16 Week 16 Percentage of participants with ocular adverse events (AEs) Up to Week 52 Aqueous humor (AH) concentration of vamikibart Up to Week 52 Change from baseline in BCVA 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 Time to rescue treatment Up to Week 52 Number of PRN injections received Up to Week 52 Time to first PRN injection Up to Week 52 Change from baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) at Weeks 16 and 52 Weeks 16 and 52 Anti-drug antibody titer to vamikibart Baseline to Week 52 Percent change from baseline in corneal endothelial cell density at Week 24 Week 24 Percentage of participants with adverse events of special interest (AESIs) Up to Week 52
Trial Locations
- Locations (81)
Hospital de Santa Maria
🇵🇹Lisboa, Portugal
Ren Min Hospital Affiliated Wu Han University
🇨🇳Wuhan, China
Rambam Medical Center
🇮🇱Haifa, Israel
Hadassah MC
🇮🇱Jerusalem, Israel
Rabin MC
🇮🇱Petach Tikva, Israel
Assuta Hashalom Medical Center
🇮🇱Tel Aviv-Yafo, Israel
Tel Aviv Sourasky MC
🇮🇱Tel Aviv, Israel
Seoul St Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Instituto de Oftalmologia Dr. Gama Pinto
🇵🇹Lisboa, Portugal
Kaiser Permanente Southern California
🇺🇸Los Angeles, California, United States
Colorado Retina Associates, PC
🇺🇸Lakewood, Colorado, United States
Retina Vitreous Associates of Florida
🇺🇸Saint 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
Oregon Health & Science Uni
🇺🇸Portland, Oregon, United States
Erie Retina Research
🇺🇸Erie, Pennsylvania, United States
Palmetto Retina Center
🇺🇸West Columbia, South Carolina, United States
Tennessee Retina PC
🇺🇸Nashville, Tennessee, United States
Austin Clinical Research LLC
🇺🇸Austin, Texas, United States
Texas Retina Associates
🇺🇸Dallas, Texas, United States
LKH-Univ.Klinikum Graz
🇦🇹Graz, Austria
Kepler Universitätskliniken GmbH - Med Campus III
🇦🇹Linz, Austria
Medizinische Universität Wien
🇦🇹Wien, Austria
Retina Clinic
🇧🇷Sao Paulo, São Paulo, Brazil
Universidade Federal de Sao Paulo - UNIFESP*X
🇧🇷Sao Paulo, São Paulo, Brazil
CEMAPE - Centro Médico
🇧🇷Sao Paulo, São Paulo, Brazil
Fiocruz - Fundação Oswaldo Cruz
🇧🇷Rio de Janeiro, Brazil
Kensington Vision and Research Centre
🇨🇦Toronto, Ontario, Canada
Hôpital Maisonneuve - Rosemont
🇨🇦Montreal, Quebec, Canada
CHU de Quebec-Universite Laval
🇨🇦Quebec, Canada
Peking Union Medical College Hospital
🇨🇳Beijing City, China
Beijing Tongren Hospital
🇨🇳Beijing, China
The Second Hospital of Jilin University
🇨🇳Changchun City, China
The First Affiliated Hospital, Chongqing Medical University
🇨🇳Chongqing, China
Zhongshan Ophthalmic Center, Sun Yat-sen University
🇨🇳Guangzhou City, China
Second Affiliated Hospital Zhejiang University College of Medicine
🇨🇳Hangzhou, China
Shanghai First People's Hospital
🇨🇳Shanghai, China
Tianjin Medical University Eye Hospital
🇨🇳Tianjin City, China
Eye Hospital, Wenzhou Medical University
🇨🇳Wenzhou City, China
Meir Medical Center
🇮🇱Kfar Saba, Israel
Kaplan Medical Center
🇮🇱Rehovot, Israel
AUSL ? IRCCS Santa Maria Nuova
🇮🇹Reggio Emilia, Emilia-Romagna, Italy
ASL 4 SSR Ospedale Santa Maria di Montallegro
🇮🇹Rapallo, Liguria, Italy
Irccs Ospedale San Raffaele
🇮🇹Milano, Lombardia, Italy
Asst Fatebenefratelli Sacco
🇮🇹Milano, Lombardia, Italy
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Yeungnam University Medical Center
🇰🇷Daegu, Korea, Republic of
Ajou University Medical Center
🇰🇷Gyeonggi-do, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Kim's Eye Hospital
🇰🇷Seoul, Korea, Republic of
Hospital de la Ceguera APEC
🇲🇽Mexico, D.F., Mexico CITY (federal District), Mexico
Instituto de Oftalmologia Monterrey - Vision100 (IOM)
🇲🇽Monterrey, Nuevo LEON, Mexico
Het Oogziekenhuis Rotterdam
🇳🇱Rotterdam, Netherlands
Universitair Medisch Centrum Utrecht
🇳🇱Utrecht, Netherlands
OFTALMIKA Sp. z o.o
🇵🇱Bydgoszcz, Poland
Gabinet Okulistyczny Prof Edward Wylegala
🇵🇱Katowice, Poland
SP ZOZ Szpital Uniwersytecki w Krakowie Oddzia? Kliniczny Okulistyki i Onkologii Okulistycznej
🇵🇱Krakow, Poland
SPSK nr 1 w Lublinie
🇵🇱Lublin, Poland
SPEKTRUM Osrodek Okulistyki Klinicznej
🇵🇱Wroclaw, Poland
AIBILI - Association for Innovation and Biomedical Research on Light
🇵🇹Coimbra, Portugal
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Mackay Memorial Hospital
🇨🇳Taipei, Taiwan
Chang Gung Medical Foundation - Linkou
🇨🇳Taoyuan, Taiwan
Queen Elizabeth Hospital
🇬🇧Birmingham, United Kingdom
Bradford Royal Infirmary
🇬🇧Bradford, United Kingdom
Sussex Eye Hospital
🇬🇧Brighton, United Kingdom
Bristol Eye Hospital
🇬🇧Bristol, United Kingdom
University Hospital of Wales
🇬🇧Cardiff, United Kingdom
Gloucestershire Hospitals NHS Foundation Trust
🇬🇧Gloucestershire, United Kingdom
Royal Liverpool University Hospital
🇬🇧Liverpool, United Kingdom
Western Eye Hospital
🇬🇧London, United Kingdom
Maidstone Hospital
🇬🇧Maidstone, Kent, United Kingdom
James Cook Hospital
🇬🇧Middlesbrough, United Kingdom