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NCT04757610 (OPT-302 in Neovascular Age-related Macular Degeneration): BVCT ex-ante prediction vs. reported outcome

On 14 Jan 2025, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 31 Mar 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT04757610
Acronym
ShORe
Drug Name
OPT-302
Drug MoA
recombinant fusion protein as anti-VEGFC and anti-VEGFD trap
Drug Modality
fusion protein biologic
Drug Class
First-In-Class
Therapeutic Area
Eye Diseases
Indication
Neovascular Age-related Macular Degeneration (nAMD)
Human Patients
986
Sponsor
Opthea Limited
Phase
Phase 3

Prediction of , index 1199

Prospective Prediction
Prediction Index
1199
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit in BCVA)
Technical Prediction
FAILURE (statistically maybe significant yet very weak additive clinical benefit in BCVA)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
76 days in advance
Readout Data Interpretation
OPT302 + ranibizumab failed to achieve statistical significance in BCVA compared with ranibizumab monotherapy
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant 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 3, Multicentre, Double-masked, Randomised Study to Evaluate the Efficacy and Safety of Intravitreal OPT-302 in Combination With Ranibizumab, Compared With Ranibizumab Alone, in Participants With nAMD
Phase
Phase 3
Status
Terminated
Enrollment
986
Lead sponsor
Opthea Limited
Conditions
Neovascular Age-related Macular Degeneration
Interventions
BIOLOGICAL: 2.0 mg OPT-302; BIOLOGICAL: 0.5 mg ranibizumab; PROCEDURE: Sham
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2021-03-12
Primary completion
2025-03-31
Completion
2025-03-31
Results first posted
2025-07-22
Primary outcomes
  • Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letters (Baseline to Week 52)

NCT04757610 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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