Vamikibart in Participants With Uveitic Macular Edema (Sandcat)

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

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

Study Overview

• Status: Recruiting
• Conditions: Uveitic Macular Edema
• Intervention / Treatment: Other: Sham; Drug: Vamikibart

• Study Type: Interventional
• Enrollment (Estimated): 225
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Reference Study ID Number: GR44278 https://forpatients.roche.com/; Phone Number: 888-662-6728; Email: global-roche-genentech-trials@gene.com

Study Locations

• Argentina
  • Ciudad Autonoma Buenos Aires, Argentina, C1061AAE
    • Recruiting
    • Buenos Aires Mácula
  • Ciudad Autonoma Buenos Aires, Argentina, C1033AAW
    • Recruiting
    • Centro Privado de Ojos
  • Ciudad Autonoma Buenos Aires, Argentina, C1426DQS
    • Recruiting
    • Consultorios Medicos Oftalmológicos
  • Rosario, Argentina, S2000DSK
    • Recruiting
    • Oftalmologia Global
  • San Nicolás, Argentina, C1015ABO
    • Recruiting
    • Organizacion Medica de Investigacion
• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2000
      • Recruiting
      • Sydney Eye Hospital
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • Recruiting
      • Centre For Eye Research Australia
    • Malvern, Victoria, Australia, 3144
      • Recruiting
      • Eye Surgery Associates
    • Rowville, Victoria, Australia, 3178
      • Active, not recruiting
      • Retina Specialists Victoria
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Recruiting
      • The Lions Eye Institute
• Czechia
  • Brno, Czechia, 625 00
    • Recruiting
    • Faculty Hospital Brno; Ophthalmology clinic
  • Prague, Czechia, 128 08
    • Recruiting
    • General Teaching Hospital Prague; Ophthalmology clinic
• France
  • Lyon cedex, France, 69317
    • Recruiting
    • Hopital de la croix rousse; Ophtalmologie
  • Marseille, France, 13008
    • Recruiting
    • Centre Paradis Monticelli; Ophtalmologie
  • Nantes, France, 44093
    • Recruiting
    • CHU Nantes - Hôtel Dieu; Ophthalmology
  • Paris, France, 75010
    • Recruiting
    • Hopital Lariboisiere; Ophtalmologie
  • Paris, France, 75014
    • Recruiting
    • Hôpital COCHIN; Ophtalmologie
  • Paris, France, 75651
    • Recruiting
    • Ch Pitie Salpetriere; Ophtalmologie
• Germany
  • Berlin, Germany, 13353
    • Recruiting
    • Charité-Universitätsmedizin Berlin, Campus Virchow Klinikum; Ophthalmology
  • Dessau, Germany, 06847
    • Withdrawn
    • Städtisches Klinikum Dessau; Augenklinik
  • Freiburg, Germany, 79106
    • Recruiting
    • Universitätsklinikum Freiburg, Klinik für Augenheilkunde
  • Göttingen, Germany, 37075
    • Recruiting
    • Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Augenheilkunde
  • Hamburg, Germany, 20246
    • Recruiting
    • Universitätsklinikum Hamburg-Eppendorf; Klinik und Poliklinkk für Augenheilkunde
  • Heidelberg, Germany, 69120
    • Recruiting
    • Universitätsklinik Heidelberg; Augenklinik
  • Köln, Germany, 50937
    • Recruiting
    • Universitätsklinikum Köln; Augenklinik
  • Lübeck, Germany, 23538
    • Recruiting
    • Universitätskliniikum Schleswig-Holstein, Campus Lübeck, Klinik für Augenheilkunde
  • Munster, Germany, 48145
    • Recruiting
    • St. Franziskus Hospital
  • Sulzbach, Germany, 66280
    • Recruiting
    • Knappschaftsklinikum Saar GmbH; Augenklinik Sulzbach
  • Tübingen, Germany, 72076
    • Recruiting
    • Universitäts-Augenklinik Tübingen
• India
  • Karnataka
    • Bangalore, Karnataka, India, 560010
      • Recruiting
      • Narayana Nethralaya Hospital
  • Telangana
    • Hyderabad, Telangana, India, 500034
      • Recruiting
      • L V Prasad Eye Institute
• Japan
  • Fukuoka, Japan, 812-8582
    • Recruiting
    • Kyushu University Hospital
  • Hiroshima, Japan, 734-8551
    • Active, not recruiting
    • Hiroshima University Hospital
  • Hokkaido, Japan, 060-8648
    • Recruiting
    • Hokkaido University Hospital
  • Hyogo, Japan, 650-0017
    • Recruiting
    • Kobe University Hospital
  • Kagoshima, Japan, 890-8520
    • Active, not recruiting
    • Kagoshima University Hospital
  • Kanagawa, Japan, 236-0004
    • Recruiting
    • Yokohama City University Hospital
  • Osaka, Japan, 565-0871
    • Recruiting
    • Osaka University Hospital
  • Osaka, Japan, 553-0003
    • Active, not recruiting
    • Japan Community Health care Organization Osaka Hospital
  • Saitama, Japan, 359-8513
    • Recruiting
    • National defense medical college Hospital
  • Saitama, Japan, 330-8503
    • Active, not recruiting
    • Jichi Medical University Saitama Medical Center
  • Tokyo, Japan, 160-0023
    • Recruiting
    • Tokyo Medical University Hospital
  • Tokyo, Japan, 113-8519
    • Recruiting
    • Tokyo Medical and Dental University Hospital
  • Tokyo, Japan, 206-8512
    • Recruiting
    • Nippon Medical School Tama Nagayama Hospital
  • Tokyo, Japan, 181-8611
    • Recruiting
    • Kyorin University Hospital
  • Yamaguchi, Japan, 755-8505
    • Recruiting
    • Yamaguchi University Hospital
• Singapore
  • Singapore, Singapore, 168751
    • Recruiting
    • Singapore Eye Research Institute
  • Singapore, Singapore, 119074
    • Recruiting
    • National University Hospital; Ophthalmology Department
  • Singapore, Singapore, 308433
    • Recruiting
    • Tan Tock Seng Hospital; Ophthalmology Department
• Spain
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clinic Barcelona; Servicio Oftalmologia
  • Madrid, Spain, 28040
    • Recruiting
    • Fundacion Jimenez Diaz-UTE; Servicio Oftalmologia
  • Madrid, Spain, 28040
    • Recruiting
    • Hospital Clinico San Carlos; Servicio de oftalmologia
  • Zaragoza, Spain, 50009
    • Recruiting
    • Hospital Universitario Miguel Servet; Servicio de Oftalmologia
  • Barcelona
    • Hospitalet De Llobregat, Barcelona, Spain, 8907
      • Recruiting
      • Hospital Universitari de Bellvitge; Servicio de Oftalmologia
  • Vizcaya
    • Barakaldo, Vizcaya, Spain, 48903
      • Recruiting
      • Hospital de Cruces; Servicio de Oftalmología
• Switzerland
  • Bern, Switzerland, 3010
    • Recruiting
    • Inselspital Bern Ophthalmologische Klinik
  • Bern, Switzerland, 3007
    • Recruiting
    • Berner Augenklinik
  • Binningen, Switzerland, 4102
    • Recruiting
    • Vista Klinik Ophthalmologische Klinik
  • Zürich, Switzerland, 8063
    • Recruiting
    • Stadtspital Triemli Ophthalmologische Klinik
• Turkey
  • Ankara, Turkey, 06100
    • Recruiting
    • Hacettepe University Medical Faculty; Department of Ophthalmology
  • Ankara, Turkey, 06340
    • Recruiting
    • Ankara University Medical Faculty; Department of Ophthalmology
  • Gaz?osmanpa?a, Turkey, 34250
    • Withdrawn
    • Istanbul Universitesi Istanbul Tip Fakultesi; Goz ve Kulak Burun Bogaz Cerrahi Hastanesi
  • Istanbul, Turkey, 34098
    • Withdrawn
    • Istanbul University Cerrahpasa Faculty of Medicine
  • Konya, Turkey, 42130
    • Withdrawn
    • Selcuk University Faculty of Medicine; Department Of Ophthalmology
  • Lzmir, Turkey, 35100
    • Active, not recruiting
    • Ege Universitesi Tip Fakultesi
• United States
  • Arizona
    • Mesa, Arizona, United States, 85206
      • Recruiting
      • Barnet Dulaney Perkins Eye Center
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Recruiting
      • University of Arkansas for Medical Sciences
  • California
    • Mountain View, California, United States, 94040
      • Recruiting
      • Northern California Retina Vitreous Associates
    • Pasadena, California, United States, 91107
      • Recruiting
      • California Eye Specialists Medical group Inc.
    • Redlands, California, United States, 92373
      • Recruiting
      • Retina Consultants of Southern California
    • Riverside, California, United States, 92505
      • Recruiting
      • Kaiser Permanente Riverside Medical Center
    • Sacramento, California, United States, 95825
      • Recruiting
      • Retinal Consultants Med Group
    • Sacramento, California, United States, 95817
      • Recruiting
      • University of California, Davis, Eye Center
  • Florida
    • Deerfield Beach, Florida, United States, 33064
      • Recruiting
      • Advanced Research
    • Fort Lauderdale, Florida, United States, 33308
      • Recruiting
      • Retina Group of Florida
  • Illinois
    • Oak Forest, Illinois, United States, 60452
      • Recruiting
      • University Retina and Macula Associates, PC
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • Recruiting
      • University of Michigan, Kellogg Eye Center
    • Royal Oak, Michigan, United States, 48073
      • Recruiting
      • Assoc Retinal Consultants PC
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08034
      • Recruiting
      • Mid Atlantic Retina
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Recruiting
      • Duke Eye Center
  • Ohio
    • Cleveland, Ohio, United States, 44195-0001
      • Recruiting
      • Cleveland Clinic Foundation; Cole Eye Institute
  • Texas
    • Abilene, Texas, United States, 79606
      • Recruiting
      • Retina Research Institute of Texas
    • Katy, Texas, United States, 77494
      • Recruiting
      • Retina Consultants of Texas; Katy Retina Center
    • The Woodlands, Texas, United States, 77384-4167
      • Recruiting
      • Retina Consultants of Texas
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • Recruiting
      • West Virginia University
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • Recruiting
      • University of Wisconsin; Ophthalmology and Visual Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Arm C; Participants will receive 4 sham injections Q4W to Week 12, followed by PRN sham dosing from Week 20 to Week 48.	Other: Sham; Participants will receive a sham procedure that mimics an IVT injection.
Experimental: Arm A; Participants will receive 4 low-dose vamikibart intravitreal (IVT) injections every 4 weeks (Q4W) to Week 12, followed by as-needed (PRN) dosing from Week 20 to Week 48.	Drug: Vamikibart; Participants will receive vamikibart IVT injection; Other Names: RO7200220
Experimental: Arm B; Participants will receive 4 high-dose vamikibart IVT injections Q4W to Week 12, followed by PRN dosing from Week 20 to Week 48.	Drug: Vamikibart; Participants will receive vamikibart IVT injection; Other Names: RO7200220

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of participants with ≥ 15 letter improvement from baseline in best-corrected visual acuity (BCVA) at Week 16	Week 16

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of participants with ≥ 15 letter improvement from baseline in BCVA at Week 20	Week 20
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 BCVA at Weeks 20 and 52	Weeks 20 and 52
Change from baseline in CST at Weeks 20 and 52	Weeks 20 and 52
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
Time to rescue treatment	Up to Week 52
Number of rescue treatments received	Up to Week 52
Type of rescue treatments received	Up to Week 52
Proportion of participants with ≥15 letter improvement from baseline in BCVA at Week 16 and 52	Weeks 16 and 52
Proportion of participants without ≥15 letter loss from baseline in BCVA at Week 16 and 52	Weeks 16 and 52
Time to first PRN injection	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
Percentage of participants with ocular adverse events (AEs)	Up to Week 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
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
Aqueous humor (AH) concentration of vamikibart	Up to Week 52
Serum concentration of vamikibart	Up to Week 52
Anti-drug antibody titer to vamikibart	Baseline to Week 52

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-LaRoche

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2023
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: December 6, 2022
• First Submitted That Met QC Criteria: December 6, 2022
• First Posted (Actual): December 8, 2022

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema
• Other Study ID Numbers: GR44278

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No