Vamikibart in Participants With Uveitic Macular Edema

Uveitic Macular Edema Clinical Trial

— Sandcat  

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: NCT05642325
• Other study ID #: GR44278
• Status: Recruiting
• Phase: Phase 3
• Start date: March 23, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2024
• Source: Hoffmann-La Roche
• Contact: Reference Study ID Number: GR44278 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
Argentina	Buenos Aires Mácula	Ciudad Autonoma Buenos Aires
Argentina	Centro Privado de Ojos	Ciudad Autonoma Buenos Aires
Argentina	Consultorios Medicos Oftalmológicos	Ciudad Autonoma Buenos Aires
Argentina	Oftalmologia Global	Rosario
Argentina	Organizacion Medica de Investigacion	San Nicolás
Australia	Centre For Eye Research Australia	East Melbourne	Victoria
Australia	Eye Surgery Associates	Malvern	Victoria
Australia	The Lions Eye Institute	Nedlands	Western Australia
Australia	Retina Specialists Victoria	Rowville	Victoria
Australia	Sydney Eye Hospital	Sydney	New South Wales
Czechia	Faculty Hospital Brno; Ophthalmology clinic	Brno
Czechia	General Teaching Hospital Prague; Ophthalmology clinic	Prague
France	Hopital de la croix rousse; Ophtalmologie	Lyon cedex
France	Centre Paradis Monticelli; Ophtalmologie	Marseille
France	CHU Nantes - Hôtel Dieu; Ophthalmology	Nantes
France	Ch Pitie Salpetriere; Ophtalmologie	Paris
France	Hôpital COCHIN; Ophtalmologie	Paris
France	Hopital Lariboisiere; Ophtalmologie	Paris
Germany	Charité-Universitätsmedizin Berlin, Campus Virchow Klinikum; Ophthalmology	Berlin
Germany	Universitäts-Augenklinik Bonn	Bonn
Germany	Städtisches Klinikum Dessau; Augenklinik	Dessau
Germany	Universitätsklinikum Freiburg, Klinik für Augenheilkunde	Freiburg
Germany	Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Augenheilkunde	Göttingen
Germany	Universitätsklinikum Hamburg-Eppendorf; Klinik und Poliklinkk für Augenheilkunde	Hamburg
Germany	Universitätsklinik Heidelberg; Augenklinik	Heidelberg
Germany	Universitätsklinikum Köln; Augenklinik	Köln
Germany	Universitätskliniikum Schleswig-Holstein, Campus Lübeck, Klinik für Augenheilkunde	Lübeck
Germany	St. Franziskus Hospital	Munster
Germany	Knappschaftsklinikum Saar GmbH; Augenklinik Sulzbach	Sulzbach
Germany	Universitäts-Augenklinik Tübingen	Tübingen
India	Narayana Nethralaya Hospital	Bangalore	Karnataka
India	L V Prasad Eye Institute	Hyderabad	Telangana
Japan	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	Kyorin University Hospital	Tokyo
Japan	Nippon Medical School Tama Nagayama Hospital	Tokyo
Japan	Tokyo Medical and Dental University Hospital	Tokyo
Japan	Tokyo Medical University Hospital	Tokyo
Japan	Yamaguchi University Hospital	Yamaguchi
Singapore	National University Hospital; Ophthalmology Department	Singapore
Singapore	Singapore Eye Research Institute	Singapore
Singapore	Tan Tock Seng Hospital; Ophthalmology Department	Singapore
Spain	Hospital de Cruces; Servicio de Oftalmología	Barakaldo	Vizcaya
Spain	Hospital Clinic Barcelona; Servicio Oftalmologia	Barcelona
Spain	Hospital Universitari de Bellvitge; Servicio de Oftalmologia	Hospitalet De Llobregat	Barcelona
Spain	Fundacion Jimenez Diaz-UTE; Servicio Oftalmologia	Madrid
Spain	Hospital Clinico San Carlos; Servicio de oftalmologia	Madrid
Spain	Hospital Universitario Miguel Servet; Servicio de Oftalmologia	Zaragoza
Switzerland	Berner Augenklinik	Bern
Switzerland	Inselspital Bern Ophthalmologische Klinik	Bern
Switzerland	Vista Klinik Ophthalmologische Klinik	Binningen
Switzerland	Stadtspital Triemli Ophthalmologische Klinik	Zürich
Turkey	Ankara University Medical Faculty; Department of Ophthalmology	Ankara
Turkey	Hacettepe University Medical Faculty; Department of Ophthalmology	Ankara
Turkey	Istanbul Universitesi Istanbul Tip Fakultesi; Goz ve Kulak Burun Bogaz Cerrahi Hastanesi	Gaz?osmanpa?a
Turkey	Istanbul University Cerrahpasa Faculty of Medicine	Istanbul
Turkey	Selcuk University Faculty of Medicine; Department Of Ophthalmology	Konya
Turkey	Ege Üniversitesi Tip Fakültesi	Lzmir
United States	Retina Research Institute of Texas	Abilene	Texas
United States	University of Michigan, Kellogg Eye Center	Ann Arbor	Michigan
United States	Mid Atlantic Retina	Cherry Hill	New Jersey
United States	Cleveland Clinic Foundation; Cole Eye Institute	Cleveland	Ohio
United States	Advanced Research	Deerfield Beach	Florida
United States	Duke Eye Center	Durham	North Carolina
United States	Erie Retina Research	Erie	Pennsylvania
United States	Retina Group of Florida	Fort Lauderdale	Florida
United States	Cumberland Valley Retina PC	Hagerstown	Maryland
United States	Retina Consultants of Texas; Katy Retina Center	Katy	Texas
United States	University of Arkansas For Medical Sciences	Little Rock	Arkansas
United States	University of Wisconsin; Ophthalmology and Visual Sciences	Madison	Wisconsin
United States	Barnet Dulaney Perkins Eye Center	Mesa	Arizona
United States	West Virginia University	Morgantown	West Virginia
United States	Northern California Retina Vitreous Associates	Mountain View	California
United States	Tennessee Retina PC	Nashville	Tennessee
United States	University Retina and Macula Associates, PC	Oak Forest	Illinois
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	Assoc Retinal Consultants PC	Royal Oak	Michigan
United States	Retinal Consultants Med Group	Sacramento	California
United States	University of California, Davis, Eye Center	Sacramento	California
United States	Retina Consultants of Texas	The Woodlands	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Czechia,  France,  Germany,  India,  Japan,  Singapore,  Spain,  Switzerland,  Turkey, 

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	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	Percent change from baseline in corneal endothelial cell density at Week 24		Week 24
Secondary	Percentage of participants with non-ocular AEs		Up to Week 52
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