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NCT06223958 (OTX-TKI in Neovascular Age-Related Macular Degeneration): BVCT ex-ante prediction vs. reported outcome

On 14 Nov 2025, BioinvestGPT's BVCT predicted technical success and commercial partial failure for this trial. The 13 Apr 2026 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient (non-inferior).

Clinical Trial

NCTID
NCT06223958
Acronym
SOL-1
Drug Name
OTX-TKI
Drug MoA
intravitreal sustained-release axitinib
Drug Modality
small molecule
Drug Class
Best-In-Class
Therapeutic Area
Eye Diseases
Indication
Neovascular Age-Related Macular Degeneration
Human Patients
344
Sponsor
Ocular Therapeutix Inc.
Phase
Phase 3

Prediction of , index 1476

Prospective Prediction
Prediction Index
1476
Prediction Date
Commercial Prediction
partial FAILURE (commercially maybe sufficient yet weak clinical benefit in BCVA non-inferior to aflibercept)
Technical Prediction
SUCCESS (statistically significant clinical benefit in BCVA compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
150 days in advance
Readout Data Interpretation
OTX-TKI achieved 74.1% maintaining vision at week 36 vs 55.4% achieved by aflibercept 2mg (p=0.0006); absolute BCVA gain not disclosed
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient (non-inferior)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Phase 3, Multicenter, Double-Masked, Randomized, Parallel-Group Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age-Related Macular Degeneration (nAMD)
Phase
Phase 3
Status
Active not recruiting
Enrollment
344
Lead sponsor
Ocular Therapeutix, Inc.
Conditions
Neovascular Age-Related Macular Degeneration
Interventions
DRUG: OTX-TKI (axitinib implant); DRUG: Aflibercept
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2024-01-29
Primary completion
2026-04-29
Completion
2027-09-27
Primary outcomes
  • Best corrected visual acuity (BCVA) (Up to 36 Weeks)

NCT06223958 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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