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A Phase 3, Multicenter, Prospective, Randomized, Double-Masked, Parallel-Group Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept in Subjects with Wet AMD (EYP-1901-302)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518030-83-00
Acronym
EYP-1901-302
Enrollment
143
Registered
2025-05-14
Start date
2025-06-05
Completion date
Unknown
Last updated
2025-05-25

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

Conditions

Wet age-related macular degeneration (wAMD)

Brief summary

The primary endpoint of this study is to find out whether EYP-1901 can produce the same vision benefits as aflibercept over 56 weeks.

Detailed description

The secondary endpoints of the study are to find out: 1. Total number of supplemental injections of aflibercept needed over the 56 weeks of treatment, 2. Changes in the thickness of the retina (light-sensitive membrane at the back of the eye) from Week 12 through Week 56 of treatment, 3. Number of injections a participant needs up to 96 weeks of treatment, 4. Changes in the retina structure and function over the 96 weeks of treatment

Interventions

DRUGEylea 40 mg/mL solution for injection in pre-filled syringe.

Sponsors

Eyepoint Pharmaceuticals Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary endpoint of this study is to find out whether EYP-1901 can produce the same vision benefits as aflibercept over 56 weeks.

Secondary

MeasureTime frame
The secondary endpoints of the study are to find out: 1. Total number of supplemental injections of aflibercept needed over the 56 weeks of treatment, 2. Changes in the thickness of the retina (light-sensitive membrane at the back of the eye) from Week 12 through Week 56 of treatment, 3. Number of injections a participant needs up to 96 weeks of treatment, 4. Changes in the retina structure and function over the 96 weeks of treatment

Countries

Czechia, Germany, Hungary, Poland, Slovakia

Outcome results

None listed

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