Vamikibart in Participants With Uveitic Macular Edema
- Conditions
- Uveitic Macular Edema
- Interventions
- Other: Sham
- Registration Number
- NCT05642325
- 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
- 256
- 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 Change from baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) at Weeks 16 and 52 Weeks 16 and 52 Change from Baseline in BCVA at Weeks 20 and 52 Weeks 20 and 52 Proportion of participants without ≥15 letter loss from baseline in BCVA at Week 16 and 52 Weeks 16 and 52 Percent change from baseline in corneal endothelial cell density at Week 24 Week 24 Percentage of participants with non-ocular 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 central subfield thickness (CST) at Week 16 Week 16 Change from baseline in CST at Weeks 20 and 52 Weeks 20 and 52 Time to rescue treatment Up to Week 52 Type of rescue treatments received Up to Week 52 Percentage of participants with adverse events of special interest (AESIs) 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 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 Time to first PRN injection Up to Week 52 Percentage of participants with ocular adverse events (AEs) Up to Week 52 Anti-drug antibody titer to vamikibart Baseline to Week 52
Trial Locations
- Locations (93)
Sankara Nethralaya
🇮🇳Chennai, Tamil NADU, India
L V Prasad Eye Institute
🇮🇳Hyderabad, Telangana, India
Associated Retina Consultants
🇺🇸Phoenix, Arizona, United States
Barnet Dulaney Perkins Eye Center
🇺🇸Sun City, Arizona, United States
Retina Consultants of Orange County
🇺🇸Fullerton, California, United States
Northern California Retina Vitreous Associates
🇺🇸Mountain View, California, United States
California Eye Specialists Medical group Inc.
🇺🇸Pasadena, California, United States
Retina Consultants of Southern California
🇺🇸Redlands, California, United States
Kaiser Permanente Riverside Medical Center
🇺🇸Riverside, California, United States
University of California, Davis, Eye Center
🇺🇸Sacramento, California, United States
Retinal Consultants Med Group
🇺🇸Sacramento, California, United States
Advanced Research
🇺🇸Deerfield Beach, Florida, United States
Retina Group of Florida
🇺🇸Fort Lauderdale, Florida, United States
University Retina and Macula Associates, PC
🇺🇸Oak Forest, Illinois, United States
Cumberland Valley Retina PC
🇺🇸Hagerstown, Maryland, United States
University of Michigan, Kellogg Eye Center
🇺🇸Ann Arbor, Michigan, United States
Duke Eye Center
🇺🇸Durham, North Carolina, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Erie Retina Research
🇺🇸Erie, Pennsylvania, United States
Mid Atlantic Retina
🇺🇸Philadelphia, Pennsylvania, United States
Retina Research Institute of Texas
🇺🇸Abilene, Texas, United States
Retina Consultants of Texas
🇺🇸Katy, Texas, United States
Retina Group of Washington
🇺🇸Fairfax, Virginia, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
Centro Privado de Ojos
🇦🇷Ciudad Autonoma Buenos Aires, Argentina
Buenos Aires Mácula
🇦🇷Ciudad Autonoma Buenos Aires, Argentina
Consultorios Medicos Oftalmológicos
🇦🇷Ciudad Autonoma Buenos Aires, Argentina
Oftalmologia Global
🇦🇷Rosario, Argentina
Organizacion Medica de Investigacion
🇦🇷San Nicolás, Argentina
Sydney Eye Hospital
🇦🇺Sydney, New South Wales, Australia
Centre For Eye Research Australia
🇦🇺East Melbourne, Victoria, Australia
Eye Surgery Associates
🇦🇺Malvern, Victoria, Australia
Retina Specialists Victoria
🇦🇺Rowville, Victoria, Australia
The Lions Eye Institute
🇦🇺Nedlands, Western Australia, Australia
St. Franziskus Hospital
🇩🇪Munster, Germany
Peking Union Medical College Hospital
🇨🇳Beijing City, China
Beijing Tongren Hospital
🇨🇳Beijing, China
The First Affiliated Hospital, Chongqing Medical University
🇨🇳Chongqing, China
General Teaching Hospital Prague
🇨🇿Prague, Czechia
CHU Nantes - Hôtel Dieu
🇫🇷Nantes, France
Hopital Lariboisiere
🇫🇷Paris, France
Hôpital COCHIN
🇫🇷Paris, France
Ch Pitie Salpetriere
🇫🇷Paris, France
Charité-Universitätsmedizin Berlin, Campus Virchow Klinikum
🇩🇪Berlin, Germany
Universitätsklinikum Freiburg, Klinik für Augenheilkunde
🇩🇪Freiburg, Germany
Universitätsmedizin Göttingen Georg-August-Universität
🇩🇪Göttingen, Germany
Universitätsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Universitätsklinik Heidelberg
🇩🇪Heidelberg, Germany
Universitätsklinikum Köln
🇩🇪Köln, Germany
Universitätskliniikum Schleswig-Holstein, Campus Lübeck
🇩🇪Lübeck, Germany
Knappschaftsklinikum Saar GmbH
🇩🇪Sulzbach, Germany
Universitäts-Augenklinik Tübingen
🇩🇪Tübingen, Germany
Narayana Nethralaya Hospital
🇮🇳Bangalore, Karnataka, India
ICARE Eye Hospital & PG Institute
🇮🇳Noida, Uttar Pradesh, India
Postgraduate Institute of Medical Education and Research
🇮🇳Chandigarh, India
AUSL ? IRCCS Santa Maria Nuova
🇮🇹Reggio Emilia, Emilia-Romagna, Italy
Irccs Ospedale San Raffaele
🇮🇹Milano, Lombardia, Italy
Asst Fatebenefratelli Sacco
🇮🇹Milano, Lombardia, Italy
Kyushu University Hospital
🇯🇵Fukuoka, Japan
Hiroshima University Hospital
🇯🇵Hiroshima, Japan
Hokkaido University Hospital
🇯🇵Hokkaido, Japan
Kobe University Hospital
🇯🇵Hyogo, Japan
Kagoshima University Hospital
🇯🇵Kagoshima, Japan
Yokohama City University Hospital
🇯🇵Kanagawa, Japan
Japan Community Health care Organization Osaka Hospital
🇯🇵Osaka, Japan
Osaka University Hospital
🇯🇵Osaka, Japan
Jichi Medical University Saitama Medical Center
🇯🇵Saitama, Japan
National Defense Medical College Hospital
🇯🇵Saitama, Japan
Tokyo Medical University Hospital
🇯🇵Tokyo, Japan
Kyorin University Hospital
🇯🇵Tokyo, Japan
Nippon Medical School Tama Nagayama Hospital
🇯🇵Tokyo, Japan
Yamaguchi University Hospital
🇯🇵Yamaguchi, Japan
"Kazakh "Badge of H?nour" Scientific R?s??r?h Institute of ??? diseases" LLP
🇰🇿Almaty, Kazakhstan
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Kyung Hee University Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
AIBILI - Association for Innovation and Biomedical Research on Light
🇵🇹Coimbra, Portugal
Hospital de Santa Maria
🇵🇹Lisboa, Portugal
National University Hospital
🇸🇬Singapore, Singapore
Hospital Universitari de Bellvitge
🇪🇸Hospitalet De Llobregat, Barcelona, Spain
Hospital de Cruces
🇪🇸Barakaldo, Vizcaya, Spain
Hospital Clinic Barcelona
🇪🇸Barcelona, Spain
Fundacion Jimenez Diaz-UTE
🇪🇸Madrid, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Inselspital Bern Ophthalmologische Klinik
🇨🇭Bern, Switzerland
Berner Augenklinik
🇨🇭Bern, Switzerland
Vista Klinik Ophthalmologische Klinik
🇨🇭Binningen, Switzerland
Stadtspital Triemli Ophthalmologische Klinik
🇨🇭Zürich, Switzerland
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Chang Gung Medical Foundation - Linkou
🇨🇳Taoyuan, Taiwan
Hacettepe University Medical Faculty
🇹🇷Ankara, Turkey
Ege Üniversitesi Tip Fakültesi
🇹🇷Lzmir, Turkey
Moorfields Eye Hospital NHS Foundation Trust
🇬🇧London, United Kingdom