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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
CTIS2022-501793-19-00
Acronym
GR44277
Enrollment
46
Registered
2023-04-12
Start date
2023-04-21
Completion date
2025-07-08
Last updated
2025-05-22

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

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

Detailed description

1. 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), 2. Change from baseline in BCVA score at Week 16, 3. Change from baseline in central subfield thickness (CST) at Week 16, 4. Change from baseline in BCVA at Weeks 20 and 52, 5. Change from baseline in CST at Weeks 20 and 52, 6. Proportion of participants with UME resolution from baseline at Weeks 16 and 52, 7. Proportion of participants with ≥15 letter improvement from baseline in BCVA at Week 52, 8. 12. Change from baseline in the National Eye Institute Visual Function Questionnaire‑25 (NEI VFQ‑25) composite score at Weeks 16 and 52, 9. Incidence and severity of ocular adverse events, non-ocular adverse events, adverse events of special interest and selected adverse events, 10. AH concentration of RO7200220 (pharmacokinetics) over time, 11. Serum concentration of RO7200220 (pharmacokinetics) over time, 12. Incidence and titer of ADAs to RO7200220 during the study relative to the prevalence of ADAs at baseline, 13. Time to rescue treatment and number and type of rescue treatments received, 14. Proportion of participants without ≥15 letter loss from baseline in BCVA at Weeks 16 and 52, 15. Number of pro re nata PRN injections received, 16. Time to first PRN injection, 17. Percent change from baseline in corneal endothelial cell density at Week 24 and Week 52, 18. Relationship between ADA status and efficacy, safety, ocular PK, PD endpoints, 19. IL‑6 suppression in AH

Interventions

Sponsors

F. Hoffmann-La Roche AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

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

Secondary

MeasureTime frame
1. 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), 2. Change from baseline in BCVA score at Week 16, 3. Change from baseline in central subfield thickness (CST) at Week 16, 4. Change from baseline in BCVA at Weeks 20 and 52, 5. Change from baseline in CST at Weeks 20 and 52, 6. Proportion of participants with UME resolution from baseline at Weeks 16 and 52, 7. Proportion of participants with ≥15 letter improvement from baseline in BCVA at Week 52, 8. 12. Change from baseline in the National Eye Institute Visual Function Questionnaire‑25 (NEI VFQ‑25) composite score at Weeks 16 and 52, 9. Incidence and severity of ocular adverse events, non-ocular adverse events, adverse events of special interest and selected adverse events, 10. AH concentration of RO7200220 (pharmacokinetics) over time, 11. Serum concentration of RO7200220 (pharmacokinetics) over time, 12. Incidence and titer o

Countries

Austria, Italy, Netherlands, Poland, Portugal

Outcome results

None listed

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