Clinical trial NCT05642312: A Study to Investigate 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: 245
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: Number of PRN injections received
timeFrame: Up to Week 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: Percentage of participants with non-ocular 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 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: Los Angeles
country: United States
facility: Kaiser Permanente Southern California
state: California
city: Lakewood
country: United States
facility: Colorado Retina Associates, PC
state: Colorado
city: Saint Petersburg
country: United States
facility: Retina Vitreous Associates of Florida
state: Florida
city: Hagerstown
country: United States
facility: Cumberland Valley Retina PC
state: Maryland
city: Minneapolis
country: United States
facility: VitreoRetinal Surgery, PLLC.
state: Minnesota
city: Omaha
country: United States
facility: Truhlsen Eye Institute
state: Nebraska
city: Bloomfield
country: United States
facility: Envision Ocular, LLC
state: New Jersey
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health Eye Centre
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Investigational Drug Services
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science Uni
state: Oregon
city: Erie
country: United States
facility: Erie Retina Research
state: Pennsylvania
city: West Columbia
country: United States
facility: Palmetto Retina Center
state: South Carolina
city: Nashville
country: United States
facility: Tennessee Retina PC
state: Tennessee
city: Austin
country: United States
facility: Austin Clinical Research LLC
state: Texas
city: Dallas
country: United States
facility: Texas Retina Associates
state: Texas
city: Graz
country: Austria
facility: LKH-Univ.Klinikum Graz
city: Linz
country: Austria
facility: Kepler Universitätskliniken GmbH - Med Campus III
city: Wien
country: Austria
facility: Medizinische Universität Wien
city: Sao Paulo
country: Brazil
facility: Retina Clinic
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Universidade Federal de Sao Paulo - UNIFESP*X
state: São Paulo
city: Sao Paulo
country: Brazil
facility: CEMAPE - Centro Médico
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: Fiocruz - Fundação Oswaldo Cruz
city: Toronto
country: Canada
facility: Kensington Vision and Research Centre
state: Ontario
city: Montreal
country: Canada
facility: Hôpital Maisonneuve - Rosemont
state: Quebec
city: Quebec
country: Canada
facility: CHU de Quebec-Universite Laval
city: Beijing City
country: China
facility: Peking Union Medical College Hospital
city: Beijing
country: China
facility: Beijing Tongren Hospital
city: Changchun City
country: China
facility: The Second Hospital of Jilin University
city: Chongqing
country: China
facility: The First Affiliated Hospital, Chongqing Medical University
city: Guangzhou City
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
city: Hangzhou
country: China
facility: Second Affiliated Hospital Zhejiang University College of Medicine
city: Shanghai
country: China
facility: Shanghai First People's Hospital
city: Tianjin City
country: China
facility: Tianjin Medical University Eye Hospital
city: Wenzhou City
country: China
facility: Eye Hospital, Wenzhou Medical University
city: Wuhan
country: China
facility: Ren Min Hospital Affiliated Wu Han University
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Hadassah MC
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Petach Tikva
country: Israel
facility: Rabin MC
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Tel Aviv-Yafo
country: Israel
facility: Assuta Hashalom Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky MC
city: Reggio Emilia
country: Italy
facility: AUSL ? IRCCS Santa Maria Nuova
state: Emilia-Romagna
city: Rapallo
country: Italy
facility: ASL 4 SSR Ospedale Santa Maria di Montallegro
state: Liguria
city: Milano
country: Italy
facility: Irccs Ospedale San Raffaele
state: Lombardia
city: Milano
country: Italy
facility: Asst Fatebenefratelli Sacco
state: Lombardia
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Gyeonggi-do
country: Korea, Republic of
facility: Ajou University Medical Center
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul St Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Kim's Eye Hospital
city: Mexico, D.F.
country: Mexico
facility: Hospital de la Ceguera APEC
state: Mexico CITY (federal District)
city: Monterrey
country: Mexico
facility: Instituto de Oftalmologia Monterrey - Vision100 (IOM)
state: Nuevo LEON
city: Rotterdam
country: Netherlands
facility: Het Oogziekenhuis Rotterdam
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
city: Bydgoszcz
country: Poland
facility: OFTALMIKA Sp. z o.o
city: Katowice
country: Poland
facility: Gabinet Okulistyczny Prof Edward Wylegala
city: Krakow
country: Poland
facility: SP ZOZ Szpital Uniwersytecki w Krakowie Oddzia? Kliniczny Okulistyki i Onkologii Okulistycznej
city: Lublin
country: Poland
facility: SPSK nr 1 w Lublinie
city: Wroclaw
country: Poland
facility: SPEKTRUM Osrodek Okulistyki Klinicznej
city: Coimbra
country: Portugal
facility: AIBILI - Association for Innovation and Biomedical Research on Light
city: Lisboa
country: Portugal
facility: Instituto de Oftalmologia Dr. Gama Pinto
city: Lisboa
country: Portugal
facility: Hospital de Santa Maria
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation - Linkou
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Bradford
country: United Kingdom
facility: Bradford Royal Infirmary
city: Brighton
country: United Kingdom
facility: Sussex Eye Hospital
city: Bristol
country: United Kingdom
facility: Bristol Eye Hospital
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
city: Gloucestershire
country: United Kingdom
facility: Gloucestershire Hospitals NHS Foundation Trust
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
city: London
country: United Kingdom
facility: Western Eye Hospital
city: Maidstone, Kent
country: United Kingdom
facility: Maidstone Hospital
city: Middlesbrough
country: United Kingdom
facility: James Cook Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: