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A Phase IIIb/IV, Multicenter, Randomized, Open-Label, Two-Arm Study to Investigate the Efficacy, Safety, and Durability of Faricimab Administered up to Every 24 Weeks in Patients with Neovascular Age-Related Macular Degeneration (CONSTANCE)

Status
Recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517545-13-00
Acronym
MR45638
Enrollment
89
Registered
2025-06-03
Start date
2025-06-04
Completion date
Unknown
Last updated
2026-01-21

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

Conditions

Neovascular Age-Related Macular Degeneration

Brief summary

Change from baseline in BCVA score as measured using the ETDRS VA chart at a starting distance of 4 meters

Detailed description

Change from baseline in BCVA averaged over Weeks 92, 96, and 100, Change from baseline in BCVA over time, Change from baseline in central subfield thickness (CST) averaged over Weeks 44, 48, and 52, Change from baseline in CST averaged over Weeks 92, 96, and 100, Change from baseline in CST over time, Proportion of participants on a Q4W, Q8W, Q12W, Q16W, Q20W, and Q24W treatment interval at Weeks 52 and 100, Incidence and severity of ocular adverse events, Incidence and severity of non-ocular adverse events

Interventions

DRUGVabysmo 120 mg/mL solution for injection

Sponsors

F. Hoffmann-La Roche AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change from baseline in BCVA score as measured using the ETDRS VA chart at a starting distance of 4 meters—

Secondary

MeasureTime frame
Change from baseline in BCVA averaged over Weeks 92, 96, and 100, Change from baseline in BCVA over time, Change from baseline in central subfield thickness (CST) averaged over Weeks 44, 48, and 52, Change from baseline in CST averaged over Weeks 92, 96, and 100, Change from baseline in CST over time, Proportion of participants on a Q4W, Q8W, Q12W, Q16W, Q20W, and Q24W treatment interval at Weeks 52 and 100, Incidence and severity of ocular adverse events, Incidence and severity of non-ocular adverse events—

Countries

France, Germany, Italy, Spain

Outcome results

None listed

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