A Study to Investigate Vamikibart in Participants With Uveitic Macular Edema

Uveitic Macular Edema Clinical Trial

— Meerkat  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05642312
• Other study ID #: GR44277
• Status: Recruiting
• Phase: Phase 3
• Start date: January 9, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: Hoffmann-La Roche
• Contact: Reference Study ID Number: GR44277 https://forpatients.roche.com
• Phone: 888-662-6728
• Email: global-roche-genentech-trials[@]gene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 225
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Edema
• Macular Edema
• Uveitic Macular Edema

Intervention

Drug:
• Vamikibart
Participants will receive vamikibart IVT injection

Other:
• Sham
Participants will receive a sham procedure that mimics an IVT injection.

Locations

Country	Name	City	State
Austria	LKH-Univ.Klinikum Graz; Universitäts-Augenklinik	Graz
Austria	Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Augenheilkunde	Linz
Austria	Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie	Wien
Brazil	Fiocruz - Fundação Oswaldo Cruz	Rio de Janeiro	RJ
Brazil	CEMAPE - Centro Médico	Sao Paulo	SP
Brazil	Retina Clinic	Sao Paulo	SP
Brazil	Universidade Federal de Sao Paulo - UNIFESP*X; Oftalmologia	Sao Paulo	SP
Canada	Alberta Retina Consultants	Edmonton	Alberta
Canada	Ivey Eye Institute	London	Ontario
Canada	Hôpital Maisonneuve - Rosemont	Montreal	Quebec
Canada	McGill University Health Center	Montreal	Quebec
Canada	University of Ottawa	Ottawa	Ontario
Canada	CHU de Quebec-Universite Laval	Quebec
Canada	Kensington Vision and Research Centre	Toronto	Ontario
Canada	St. Michael's Hospital; Department of Ophthalmology	Toronto	Ontario
China	Beijing Tongren Hospital	Beijing
China	Peking Union Medical College Hospital	Beijing City
China	The Second Hospital of Jilin University; ophthalmology department	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; Ophthalmology	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	Ren Min Hospital Affiliated Wu Han University	Wuhan
China	Wuxi No.2 People's Hospital	Wuxi
Israel	Rambam Medical Center; Opthalmology	Haifa
Israel	Hadassah MC; Ophtalmology	Jerusalem
Israel	Meir Medical Center; Ophtalmology	Kfar Saba
Israel	Rabin MC; Ophtalmology	Petach Tikva
Israel	Kaplan Medical Center; Ophtalmology	Rehovot
Israel	Tel Aviv Sourasky MC; Ophtalmology	Tel Aviv
Israel	Assuta Hashalom Medical Center	Tel Aviv-Yafo
Italy	ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)	Milano	Lombardia
Italy	Irccs Ospedale San Raffaele;U.O. Oculistica	Milano	Lombardia
Italy	ASL 4 SSR Ospedale Santa Maria di Montallegro; SC Oculistica, SSD Uveiti e Infiammazioni Oculari	Rapallo	Liguria
Italy	AUSL ? IRCCS Santa Maria Nuova; Immunologia Oculare	Reggio Emilia	Emilia-Romagna
Korea, Republic of	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	Asan Medical Center	Seoul
Korea, Republic of	Kim's Eye Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul St Mary's Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Mexico	Health Pharma Professional Research	Cdmx	Mexico CITY (federal District)
Mexico	Hospital de la Ceguera APEC	Mexico, D.F.	Mexico CITY (federal District)
Mexico	Instituto de Oftalmologia Monterrey - Vision100 (IOM)	Monterrey	Nuevo LEON
Mexico	CODET Vision Institute	Tijuana	BAJA California
Netherlands	Het Oogziekenhuis Rotterdam	Rotterdam
Netherlands	Universitair Medisch Centrum Utrecht	Utrecht
Poland	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; Klinika Chirurgii Siatkowki i Ciala Szklistego	Lublin
Poland	SPEKTRUM Osrodek Okulistyki Klinicznej	Wroclaw
Portugal	AIBILI - Association for Innovation and Biomedical Research on Light	Coimbra
Portugal	Hospital de Santa Maria; Servico de Oftalmologia	Lisboa
Portugal	Instituto de Oftalmologia Dr. Gama Pinto	Lisboa
Taiwan	Mackay Memorial Hospital; Ophthalmology	Taipei
Taiwan	Taipei Veterans General Hospital; Ophthalmology	Taipei
Taiwan	Chang Gung Medical Foundation - Linkou; Ophthalmology	Taoyuan
United Kingdom	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; St Paul's Clinical Eye Research Centre	Liverpool
United Kingdom	Moorfields Eye Hospital NHS Foundation Trust	London
United Kingdom	Western Eye Hospital	London
United Kingdom	Maidstone Hospital; Eye Unit	Maidstone, Kent
United Kingdom	James Cook Hospital	Middlesbrough
United States	Emory Eye Center	Atlanta	Georgia
United States	Austin Clinical Research LLC	Austin	Texas
United States	Envision Ocular, LLC	Bloomfield	New Jersey
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	The Ohio State University Investigational Drug Services	Columbus	Ohio
United States	Texas Retina Associates	Dallas	Texas
United States	VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota	Edina	Minnesota
United States	Erie Retina Research	Erie	Pennsylvania
United States	Cumberland Valley Retina PC	Hagerstown	Maryland
United States	Colorado Retina Associates, PC	Lakewood	Colorado
United States	Jules Stein Eye Institute/ UCLA	Los Angeles	California
United States	Tennessee Retina PC	Nashville	Tennessee
United States	Vanderbilt Eye Institute	Nashville	Tennessee
United States	Wagner Kapoor Institute	Norfolk	Virginia
United States	Truhlsen Eye Institute	Omaha	Nebraska
United States	Legacy Emanuel Hospital and Health Center	Portland	Oregon
United States	Oregon Health & Science Uni	Portland	Oregon
United States	Kaiser Permanente Southern California	Riverside	California
United States	Retina Vitreous Associates of Florida	Saint Petersburg	Florida
United States	University of Washington	Seattle	Washington
United States	The Retina Consultants	Slingerlands	New York
United States	Spokane Eye Clinical Research	Spokane	Washington
United States	Palmetto Retina Center	West Columbia	South Carolina
United States	Wake Forest Baptist Health Eye Centre	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Austria,  Brazil,  Canada,  China,  Israel,  Italy,  Korea, Republic of,  Mexico,  Netherlands,  Poland,  Portugal,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with = 15 letter improvement from baseline in best-corrected visual acuity (BCVA) at Week 16		Week 16
Secondary	Proportion of participants with = 15 letter improvement from baseline in BCVA at Week 20		Week 20
Secondary	Change from baseline in BCVA at Week 16		Week 16
Secondary	Change from baseline in central subfield thickness (CST) at Week 16		Week 16
Secondary	Change from Baseline in BCVA at Weeks 20 and 52		Weeks 20 and 52
Secondary	Change from baseline in CST at Weeks 20 and 52		Weeks 20 and 52
Secondary	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
Secondary	Time to rescue treatment		Up to Week 52
Secondary	Number of rescue treatments received		Up to Week 52
Secondary	Type of rescue treatments received		Up to Week 52
Secondary	Proportion of participants with =15 letter improvement from baseline in BCVA at Week 16 and 52		Weeks 16 and 52
Secondary	Proportion of participants without =15 letter loss from baseline in BCVA at Week 16 and 52		Weeks 16 and 52
Secondary	Number of PRN injections received		Up to Week 52
Secondary	Time to first PRN injection		Up to Week 52
Secondary	Change from baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) at Weeks 16 and 52		Weeks 16 and 52
Secondary	Percentage of participants with ocular adverse events (AEs)		Up to Week 52
Secondary	Percentage of participants with non-ocular AEs		Up to Week 52
Secondary	Percent change from baseline in corneal endothelial cell density at Week 24		Week 24
Secondary	Percentage of participants with adverse events of special interest (AESIs)		Up to Week 52
Secondary	Percent change from baseline in corneal endothelial cell density at Week 52		Week 52
Secondary	Aqueous humor (AH) concentration of vamikibart		Up to Week 52
Secondary	Serum concentration of vamikibart		Up to Week 52
Secondary	Anti-drug antibody titer to vamikibart		Baseline to Week 52