Phase 2 N=77 Randomized Triple-blind Treatment

Study of EYP-1901 in Patients With Nonproliferative Diabetic Retinopathy (NPDR)

Nonproliferative Diabetic Retinopathy

Bottom Line

View on ClinicalTrials.gov: NCT05383209 ↗

Enrolled (actual)

Serious AEs

6.1%

Results posted

Jul 2025

Primary outcome: Primary: Percentage of Subjects Improved >=2 Steps From Baseline in the DRSS Score at Week 36 — 5.0; 0; 4.8 percentage of subjects

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: EYP-1901 (Drug); Sham IVT (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: EyePoint Pharmaceuticals, Inc.
Primary completion: Feb 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Subjects Improved >=2 Steps From Baseline in the DRSS Score at Week 36	5.0; 0; 4.8	—
SECONDARY Percentage of Subjects Improved >=2 Steps From Baseline in the DRSS Score at Week 24 and Week 48	0; 0; 0; 0; 0; 5.3	—
SECONDARY Percentage of Subjects Improved >=2 Steps and >=3 Steps From Baseline in DRSS Score at Weeks 24, 36 and 48	0; 0; 0; 5.0; 0; 4.8	—
SECONDARY Percentage of Subjects Worsened >=2 Steps and >=3 Steps From Baseline in DRSS Score at Weeks 24, 36 and 48	0; 6.3; 0; 10.0; 5.0; 0	—
SECONDARY Percentage of Subjects Who Developed a Vision-Threatening Complication Due to Diabetic Retinopathy at Weeks 24, 36 and 48	0; 3.8; 0; 3.8; 3.8; 0	—
SECONDARY Percentage of Subjects Who Developed Center Involved-Diabetic Macular Edema (CI-DME) at Weeks 24, 36 and 48	0; 0; 0; 0; 0; 4.0	—
SECONDARY Time to Develop Any Neovascular Vision Threatening Complication (PDR/ASNV) at Weeks 24, 36 and 48	NA; NA; NA; NA; NA	—
SECONDARY Time to Develop CI-DME Through Weeks 24, 36 and 48	NA; NA; NA	—
SECONDARY Percentage of Subjects Who Received Anti-Vascular Endothelial Growth Factor (VEGF) or Additional Standard of Care Intervention Due to Ocular Diabetic Complications at Weeks 24, 36 and 48	7.7; 7.7; 4.0; 7.7; 7.7; 8.0	—
SECONDARY Percentage of Subjects Who Received PRP at Weeks 24, 36 and 48	0; 3.8; 0; 0; 3.8; 0	—
SECONDARY Area Under the Curve (AUC) for Change From Baseline in BCVA at Weeks 24, 36 and 48	-0.32; -1.58; 0.46; -0.23; -1.52; 0.03	—
SECONDARY Plasma Concentration of EYP-1901 and X-297 at Weeks 24, 36 and 48	11.852; 14.064; 7.660; 9.708; 6.698; 8.194	—
SECONDARY Number of Subjects With Ocular and Non-Ocular TEAEs and Serious TEAEs up to Week 48	7; 9; 15; 7; 8; 16	—

Summary

A prospective, randomized, double-masked study that evaluated the ocular efficacy and safety of two doses of the EYP-1901 intravitreal (IVT) insert compared to sham.

Eligibility Criteria

Inclusion Criteria

Participants must have a hemoglobin A1c =69 letters (approximate Snellen equivalent of 20/40 or better).

Exclusion Criteria

Presence of any active Center involved-diabetic macular edema in the study eye as determined by the Investigator on clinical examination, or within the central subfield thickness (CST) of the study eye, with a CST threshold greater than 320 microns.
Any evidence or documented history of prior focal or grid laser photocoagulation or any pan-retinal photocoagulation (PRP) in the study eye in the last 12 months.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05383209). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.