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NCT05383209 (EYP-1901 Sham IVT in Nonproliferative Diabetic Retinopathy): BVCT ex-ante prediction vs. reported outcome

On 14 Feb 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 6 May 2024 readout is classified on the dashboard as False Positive (FP), a missed prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT05383209
Acronym
PAVIA
Drug Name
EYP-1901 Sham IVT
Drug MoA
intravitreally delivered vorolanib
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Eye Diseases
Indication
Nonproliferative Diabetic Retinopathy
Human Patients
105
Sponsor
EyePoint Pharmaceuticals
Phase
Phase 2

Prediction of , index 1142

Prospective Prediction
Prediction Index
1142
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit non-inferior to long-lasting aflibercept)
Technical Prediction
SUCCESS (statistically significant clinical benefit non-inferior to aflibercept in BCVA)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
82 days in advance
Readout Data Interpretation
DRSS>2 score primary endpoint not met.
Press Release
Prediction Result
Prediction Accuracy
Missed Prediction
Due to
due to suboptimal modelling of non-proliferative diabetic retinopathy which has been permanently corrected.
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
False Positive (FP)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Phase 2, Multicenter, Prospective, Double-masked, Parallel Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Sham for the Improvement of Moderately Severe to Severe Nonproliferative Diabetic Retinopathy (NPDR)
Phase
Phase 2
Status
Completed
Enrollment
77
Lead sponsor
EyePoint Pharmaceuticals, Inc.
Conditions
Nonproliferative Diabetic Retinopathy
Interventions
DRUG: EYP-1901; OTHER: Sham IVT
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2022-09-28
Primary completion
2024-02-12
Completion
2024-05-06
Results first posted
2025-07-28
Primary outcomes
  • Percentage of Subjects Improved >=2 Steps From Baseline in the DRSS Score at Week 36 (Baseline (Day 1) and Week 36)

NCT05383209 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials