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A Phase 3, Randomized, Double-Masked, Active-Controlled Trial of a Single Intravitreal Injection of 4D-150 in Adults with Macular Neovascularization Secondary to Age-Related Macular Degeneration (4FRONT-2)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521349-25-00
Acronym
4D-150-C004
Enrollment
298
Registered
2025-11-21
Start date
2025-12-09
Completion date
Unknown
Last updated
2025-12-19

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

Conditions

Macular neovascularization secondary to age-related macular degeneration (nAMD)

Brief summary

Mean change from baseline in BCVA ETDRS letter score at Week 52

Detailed description

Mean annualized number of aflibercept injections after Week 4 through Weeks 52 and 104, Incidence and timing of aflibercept injections after Week 4 through Weeks 52 and 104, Proportion of subjects not requiring aflibercept injections after Week 4 through Weeks 52 and 104 in the 4D-150 arm, Time to first aflibercept injection after Week 4 in the 4D-150 arm, Mean change from baseline in CST over time through Weeks 52 and 104, Mean change from baseline in BCVA ETDRS letter score over time through Weeks 52 and 104

Interventions

Sponsors

4d Molecular Therapeutics Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Mean change from baseline in BCVA ETDRS letter score at Week 52

Secondary

MeasureTime frame
Mean annualized number of aflibercept injections after Week 4 through Weeks 52 and 104, Incidence and timing of aflibercept injections after Week 4 through Weeks 52 and 104, Proportion of subjects not requiring aflibercept injections after Week 4 through Weeks 52 and 104 in the 4D-150 arm, Time to first aflibercept injection after Week 4 in the 4D-150 arm, Mean change from baseline in CST over time through Weeks 52 and 104, Mean change from baseline in BCVA ETDRS letter score over time through Weeks 52 and 104

Countries

Bulgaria, France, Germany, Hungary, Italy, Latvia, Lithuania, Portugal, Spain

Outcome results

None listed

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