Clinical trial NCT05642325: Vamikibart in Participants With Uveitic Macular Edema
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Uveitic Macular Edema
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2022-12-08
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

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