BioinvestGPT

BioinvestGPT ApS · Research use only

NCT05536973 (ADVM-022 in Neovascular Age-related Macular Degeneration): BVCT ex-ante prediction vs. reported outcome

On 18 Jul 2023, BioinvestGPT's BVCT predicted technical success and commercial failure for this trial. The 8 Feb 2024 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
NCT05536973
Acronym
LUNA
Drug Name
ADVM-022
Drug MoA
AAV aflibercept gene therapy
Drug Modality
gene therapy
Drug Class
First-In-Class
Therapeutic Area
Eye Diseases
Indication
Neovascular Age-related Macular Degeneration
Human Patients
69
Sponsor
Adverum Biotechnologies
Phase
Phase 2

Prediction of , index 1181

Prospective Prediction
Prediction Index
1181
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit inferior to aflibercept)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
205 days in advance
Readout Data Interpretation
-1.7 BCVA 26 weeks vs +4 BCVA for 24 weeks achieved by ranibizumab; negative dose-response relationship
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 Multi-Center, Randomized, Double-Masked Phase 2 Study to Assess Safety and Efficacy of ADVM-022 (AAV.7m8-aflibercept) in Anti-VEGF Treatment-Experienced Patients With Neovascular (Wet) Age-related Macular Degeneration (nAMD) [LUNA]
Phase
Phase 2
Status
Active not recruiting
Enrollment
69
Lead sponsor
Adverum Biotechnologies, Inc.
Conditions
Neovascular Age-related Macular Degeneration
Interventions
GENETIC: ADVM-022; GENETIC: ADVM-022
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2022-08-23
Primary completion
2024-08-26
Completion
2028-08
Primary outcomes
  • Incidence of ocular and non-ocular adverse events (Up to Week 52)
  • Severity of ocular and non-ocular adverse events (Up to Week 52)
  • Mean change in best corrected visual acuity (BCVA) from Baseline (Baseline up to Week 52)

NCT05536973 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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