vamikibart (RG6179) / Roche, CARISMA Therap - LARVOL DELTA

Vamikibart in Participants With Uveitic Macular Edema (clinicaltrials.gov) - P3 | N=256 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Trial primary completion date: Dec 2025 ➔ May 2025

Trial primary completion date • Macular Edema • Ophthalmology • Uveitis

Intravitreal IL-6 inhibition with vamikibart in uveitic macular edema (UME): baseline characteristics of the DOVETAIL phase 1 study (ARVO 2025) - "Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

P1 data • Diabetic Macular Edema • Macular Edema • Ocular Inflammation • Ophthalmology • Retinal Disorders • Uveitis

Real-world treatment patterns in patients with macular edema (ME) due to noninfectious uveitis (NIU) in the United States (ARVO 2025) - "Two ongoing global randomized, controlled, identically designed, phase 3 studies are investigating vamikibart, an IVT anti–IL-6 MAB, in NIU with UME. Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Clinical • HEOR • Real-world • Real-world evidence • Macular Edema • Ocular Inflammation • Ophthalmology • Uveitis

DOVETAIL: A Study to Investigate RO7200220 as Monotherapy and in Combination With Ranibizumab in Participants With Diabetic and Uveitic Macular Edema (clinicaltrials.gov) - P1 | N=85 | Completed | Sponsor: Hoffmann-La Roche

Monotherapy • New P1 trial • Diabetic Macular Edema • Macular Edema • Ophthalmology

Vamikibart in Participants With Uveitic Macular Edema (clinicaltrials.gov) - P3 | N=256 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2025 ➔ Dec 2025 | Trial primary completion date: Jun 2025 ➔ Dec 2025

Enrollment closed • Trial completion date • Trial primary completion date • Macular Edema • Ophthalmology • Uveitis

A Study to Investigate Vamikibart in Participants With Uveitic Macular Edema (clinicaltrials.gov) - P3 | N=245 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Trial primary completion date: Jun 2025 ➔ Dec 2024

Trial primary completion date • Macular Edema • Ophthalmology • Uveitis

A Study to Investigate Vamikibart (RO7200220) in Combination With Ranibizumab in Diabetic Macular Edema (clinicaltrials.gov) - P2 | N=187 | Completed | Sponsor: Hoffmann-La Roche | Active, not recruiting ➔ Completed

Combination therapy • Trial completion • Diabetic Macular Edema • Ophthalmology

A Study to Investigate Vamikibart in Participants With Uveitic Macular Edema (clinicaltrials.gov) - P3 | N=225 | Recruiting | Sponsor: Hoffmann-La Roche | Active, not recruiting ➔ Recruiting

Enrollment open • Macular Edema • Ophthalmology • Uveitis

A Study to Investigate Vamikibart in Participants With Uveitic Macular Edema (clinicaltrials.gov) - P3 | N=225 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Recruiting ➔ Active, not recruiting

Enrollment closed • Macular Edema • Ophthalmology • Uveitis

Longitudinal quantitative ultra-widefield fluorescein angiography leakage dynamics in patients with uveitic macular edema following intravitreal anti–IL-6 therapy with vamikibart (ARVO 2024) - "These promising preliminary results confirm the feasibility of quantitative UWFA leakage analysis and indicate a potential reduction in quantitative leakage parameters in eyes with UME undergoing anti–IL-6 treatment. Future analyses are needed to further characterize these changes in the entire study population as well as a more detailed assessment to investigate the effect of vamikibart anti–IL-6 treatment on UME severity and functional outcomes. Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand."

Clinical • Diabetic Macular Edema • Macular Edema • Ocular Inflammation • Ophthalmology • Uveitis

Aqueous humor interleukin-6 levels in uveitic macular edema: baseline characteristics from the phase 1 DOVETAIL study (ARVO 2024) - "Consistent with previous studies, BL levels of AH IL-6 were high in patients with UME. Trends were seen between higher levels of AH IL-6 at BL and higher CST and presence of SRF. However, the sample size was small, so these trends need to be investigated further in a larger population to determine the clinical relevance of the findings.ReferencesNoma H et al."

P1 data • Diabetic Macular Edema • Macular Edema • Ocular Inflammation • Ophthalmology • Uveitis • IL6

Volumetric fluid dynamics using machine-learning augmented analysis in patients with uveitic macular edema receiving vamikibart in the DOVETAIL study (ARVO 2024) - "Preliminary results demonstrate feasibility of volumetric fluid quantification with evidence of notable anatomic improvement with anti-IL-6 intravitreal therapy. Ongoing analyses will further assess the overall link between fluid dynamics, clinical outcomes, and quantitative angiographic assessment. Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand."

Clinical • Machine learning • Diabetic Macular Edema • Macular Edema • Ocular Inflammation • Ophthalmology • Uveitis

Intravitreal interleukin-6 inhibition with vamikibart in sarcoidosis-associated uveitis (ARVO 2024) - "Preliminary evidence from these 5 patients from the DOVETAIL trial suggests that vamikibart may be effective and well tolerated in patients with UME associated with sarcoid uveitis. Further investigation is needed to assess clinical effects of vamikibart in a larger patient population. Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand."

Diabetic Macular Edema • Ocular Inflammation • Ophthalmology • Uveitis • IL6

IL-6 inhibition with vamikibart in patients with uveitic macular edema: phase 3 MEERKAT and SANDCAT trials (ARVO 2024) - P3 | "The ongoing global phase 3 MEERKAT and SANDCAT program will evaluate vamikibart and its potential to address the unmet need for effective noncorticosteroid treatments in UME.Reference1. Sharma et al. Invest Ophthalmol Vis Sci."

Clinical • P3 data • Macular Edema • Ocular Inflammation • Ophthalmology • Uveitis • IL6

Longitudinal Quantitative Anterior Chamber Cell Analysis Following Vamikibart Intravitreal Therapy in Patients with Uveitic Macular Edema from the DOVETAIL Clinical Trial (ARVO 2024) - "This analysis demonstrated promising preliminary results confirming the feasibility of quantitative measurement of AC cells on AS-OCT analysis in an UME clinical trial and indicated reduction in AC cell density in eyes undergoing anti-IL-6 IVT treatment. Future analyses are needed to further characterize these changes in the entire study population once the trial has completed, as well as a more detailed assessment to investigate the differences in clinician grading decisions and the quantitative cell density measurements. Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand."

Clinical • Diabetic Macular Edema • Macular Edema • Ocular Inflammation • Ophthalmology • Uveitis

A Study to Investigate Vamikibart (RO7200220) in Diabetic Macular Edema (clinicaltrials.gov) - P2 | N=394 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Recruiting ➔ Active, not recruiting

Enrollment closed • Diabetic Macular Edema • Ophthalmology

A Study to Investigate RO7200220 in Combination With Ranibizumab in Diabetic Macular Edema (clinicaltrials.gov) - P2 | N=187 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Diabetic Macular Edema • Ophthalmology

A novel anti-IL-6 monoclonal antibody leads to restoration of IL-6-mediated endothelial barrier breakdown (ARVO 2023) - "RG6179 is a recombinant monoclonal antibody that potently inhibits all forms of IL-6 signaling...Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Ophthalmology • Retinal Disorders • ICAM1 • IL6R

A novel intravitreal anti-IL-6 monoclonal antibody for uveitic macular edema (UME): preliminary results from the phase 1 DOVETAIL study (ARVO 2023) - "RG6179 is a recombinant monoclonal antibody that potently inhibits all forms of IL-6 signaling...Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

P1 data • Cataract • Diabetic Macular Edema • Macular Edema • Ocular Inflammation • Ophthalmology • Retinal Disorders • Uveitis

RO7200220 in Participants With Uveitic Macular Edema (clinicaltrials.gov) - P3 | N=225 | Recruiting | Sponsor: Hoffmann-La Roche | Not yet recruiting ➔ Recruiting

Enrollment open • Macular Edema • Ophthalmology • Uveitis

A Study to Investigate RO7200220 in Combination With Ranibizumab in Diabetic Macular Edema (clinicaltrials.gov) - P2 | N=230 | Recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Jan 2024 ➔ Sep 2024 | Trial primary completion date: Jan 2024 ➔ May 2024

Combination therapy • Trial completion date • Trial primary completion date • Diabetic Macular Edema • Ophthalmology

A Study to Investigate RO7200220 in Diabetic Macular Edema (clinicaltrials.gov) - P2 | N=400 | Recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Jan 2024 ➔ May 2025 | Trial primary completion date: Jan 2024 ➔ Dec 2024

Trial completion date • Trial primary completion date • Diabetic Macular Edema • Ophthalmology

A Study to Investigate RO7200220 in Participants With Uveitic Macular Edema (clinicaltrials.gov) - P3 | N=225 | Recruiting | Sponsor: Hoffmann-La Roche | Not yet recruiting ➔ Recruiting

Enrollment open • Macular Edema • Ophthalmology • Uveitis

RO7200220 in Participants With Uveitic Macular Edema (clinicaltrials.gov) - P3 | N=225 | Not yet recruiting | Sponsor: Hoffmann-La Roche

New P3 trial • Macular Edema • Ophthalmology • Uveitis

A Study to Investigate RO7200220 in Participants With Uveitic Macular Edema (clinicaltrials.gov) - P3 | N=225 | Not yet recruiting | Sponsor: Hoffmann-La Roche

New P3 trial • Macular Edema • Ophthalmology • Uveitis