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NCT05197270 (4D-150 IVT Aflibercept IVT in Neovascular Age-Related Macular Degeneration): BVCT ex-ante prediction vs. reported outcome

On 3 Dec 2023, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 3 Feb 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially insufficient.

Clinical Trial

NCTID
NCT05197270
Acronym
PRISM
Drug Name
4D-150 IVT Aflibercept IVT
Drug MoA
AAV aflibercept and VEGFC RNAi gene therapy
Drug Modality
gene therapy
Drug Class
First-In-Class
Therapeutic Area
Eye Diseases
Indication
Neovascular (Wet) Age-Related Macular Degeneration
Human Patients
150
Sponsor
4D Molecular Therapeutics
Phase
Phase 1 Phase 2

Prediction of , index 1004

Prospective Prediction
Prediction Index
1004
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit inferior to aflibercept)
Technical Prediction
FAILURE (statistically insignificant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
62 days in advance
Readout Data Interpretation
#ERROR!
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Phase 1/2 Dose-Escalation and Randomized, Controlled, Masked Expansion Trial of Intravitreal 4D-150 Gene Therapy in Adults With Neovascular (Wet) Age-Related Macular Degeneration
Phase
Phase 1, Phase 2
Status
Recruiting
Enrollment
215
Lead sponsor
4D Molecular Therapeutics
Conditions
Neovascular (Wet) Age-Related Macular Degeneration
Interventions
BIOLOGICAL: 4D-150 IVT; BIOLOGICAL: Aflibercept IVT
Design
Randomized · Sequential · Single
Primary purpose
Treatment
Start
2021-12-09
Primary completion
2027-03
Completion
2031-01
Primary outcomes
  • Incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs), including clinically significant changes in safety parameters (52 weeks)

NCT05197270 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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