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A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE MASKED, SHAM-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF RO7200220 ADMINISTERED INTRAVITREALLY IN PATIENTS WITH UVEITIC MACULAR EDEMA

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-501794-39-00
Acronym
GR44278
Enrollment
70
Registered
2023-04-20
Start date
2023-06-28
Completion date
2025-11-27
Last updated
2025-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uveitic Macular Edema

Brief summary

Proportion of participants with ≥15 letter improvement from baseline in BCVA at Week 16

Detailed description

Proportion of participants with ≥15 letter improvement from baseline in BCVA at Week 20 (8 weeks after the final fixed-interval study drug dose at week 12), Change from baseline in BCVA score at Week 16, Change from baseline in central subfield thickness (CST) at Week 16, Change from baseline in BCVA at Weeks 20 and 52, Change from baseline in CST at Weeks 20 and 52, Proportion of participants with UME resolution from baseline at Weeks 16 and 52, Time to rescue treatment and number and type of rescue treatments received, Proportion of participants with ≥15 letter improvement from baseline in BCVA at Week 52, Proportion of participants without ≥15 letter loss from baseline in BCVA at Weeks 16 and 52 French 9. Proportion de participants sans, Number of pro re nata (PRN) injections received, Time to first PRN injection, Change from baseline in the National Eye Institute Visual Function Questionnaire‑25 NEI VFQ‑25 composite score at Weeks 16 and 52, Incidence and severity of ocular adverse events, non-ocular adverse events, adverse events of special interest and selected adverse events, Percent change from baseline in corneal endothelial cell density at Weeks 24 and 52, AH concentration of RO7200220 (pharmacokinetics) over time, Serum concentration of RO7200220 (pharmacokinetics) over time, IL‑6 suppression in AH, Incidence and titer of ADAs to RO7200220 during the study relative to the prevalence of ADAs at baseline, Relationship between ADA status and efficacy, safety, ocular PK, PD endpoints

Interventions

Sponsors

F. Hoffmann-La Roche AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Proportion of participants with ≥15 letter improvement from baseline in BCVA at Week 16

Secondary

MeasureTime frame
Proportion of participants with ≥15 letter improvement from baseline in BCVA at Week 20 (8 weeks after the final fixed-interval study drug dose at week 12), Change from baseline in BCVA score at Week 16, Change from baseline in central subfield thickness (CST) at Week 16, Change from baseline in BCVA at Weeks 20 and 52, Change from baseline in CST at Weeks 20 and 52, Proportion of participants with UME resolution from baseline at Weeks 16 and 52, Time to rescue treatment and number and type of rescue treatments received, Proportion of participants with ≥15 letter improvement from baseline in BCVA at Week 52, Proportion of participants without ≥15 letter loss from baseline in BCVA at Weeks 16 and 52 French 9. Proportion de participants sans, Number of pro re nata (PRN) injections received, Time to first PRN injection, Change from baseline in the National Eye Institute Visual Function Questionnaire‑25 NEI VFQ‑25 composite score at Weeks 16 and 52, Incidence and severity of ocular adve

Countries

Czechia, France, Germany, Italy, Poland, Portugal, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026