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NCT05891548 (CLS-AX in Wet Age-Related Macular Degeneration): BVCT ex-ante prediction vs. reported outcome

On 10 May 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 9 Oct 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially insufficient (non-superior to aflibercept).

Clinical Trial

NCTID
NCT05891548
Acronym
ODYSSEY
Drug Name
CLS-AX
Drug MoA
axitinib injectable suspension
Drug Modality
small molecule
Drug Class
Best-In-Class
Therapeutic Area
Eye Diseases
Indication
Wet Age-Related Macular Degeneration
Human Patients
60
Sponsor
Clearside Biomedical
Phase
Phase 2

Prediction of , index 1589

Prospective Prediction
Prediction Index
1589
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit with non-superior-to-long-lasting-aflibercept efficacy in BCVA)
Technical Prediction
partial SUCCESS (statistically significant yet moderate clinical benefit in BCVA)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
152 days in advance
Readout Data Interpretation
CLS-AX achieved -1.9 BCVA score at week 36 whereas aflibercept in the active control arm achieved +1.5 BCVA score at week 36 (p=0.243); showing that CLS-AX is non-superior to aflibercept.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially insufficient (non-superior to aflibercept)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
ODYSSEY: A Phase 2b Study of Suprachoroidally Administered CLS-AX in Participants With Neovascular Age-Related Macular Degeneration
Phase
Phase 2
Status
Completed
Enrollment
60
Lead sponsor
Clearside Biomedical, Inc.
Conditions
Neovascular Age-related Macular Degeneration
Interventions
DRUG: CLS-AX; DRUG: Aflibercept
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2023-05-31
Primary completion
2024-08-20
Completion
2024-08-20
Primary outcomes
  • Evaluations of Outcomes Related to ETDRS BCVA in the Study Eye Over Time (Baseline, Weeks 4, 12, 16, 20, 24, 28, 32 and 36)

NCT05891548 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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