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NCT04514653 (RGX-314 Ranibizumab Local steroid… in Neovascular Age-Related Macular Degeneration): BVCT ex-ante prediction vs. reported outcome

On 9 Jul 2023, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 16 Jan 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
NCT04514653
Acronym
AAVIATE
Drug Name
RGX-314 Ranibizumab Local steroid Topical steroid
Drug MoA
AAV anti-VEGF gene therapy
Drug Modality
gene therapy
Drug Class
First-In-Class
Therapeutic Area
Eye Diseases
Indication
Neovascular Age-Related Macular Degeneration (nAMD)
Human Patients
115
Sponsor
AbbVie / REGENXBIO
Phase
Phase 2

Prediction of , index 1161

Prospective Prediction
Prediction Index
1161
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit inferior to ranibizumab)
Technical Prediction
FAILURE (statistically insignificant clinical benefit inferior to ranibizumab)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
191 days in advance
Readout Data Interpretation
-1 to -2.8 BCVA 6 months vs +4 for ranibizumab.
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 2, Randomized, Dose-escalation, Ranibizumab-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of RGX-314 Gene Therapy Delivered Via One or Two Suprachoroidal Space (SCS) Injections in Participants With Neovascular Age-Related Macular Degeneration (nAMD) (AAVIATE)
Phase
Phase 2
Status
Active not recruiting
Enrollment
146
Lead sponsor
AbbVie
Conditions
Neovascular Age-Related Macular Degeneration (nAMD)
Interventions
BIOLOGICAL: Ranibizumab; GENETIC: ABBV-RGX-314 Dose 1; GENETIC: ABBV-RGX-314 Dose 2; GENETIC: ABBV-RGX-314 Dose 3; DRUG: Local Steroid; DRUG: Topical Steroid; GENETIC: ABBV-RGX-314 Dose 4
Design
Randomized · Sequential · Single
Primary purpose
Treatment
Start
2020-08-25
Primary completion
2026-08
Completion
2027-02
Primary outcomes
  • Mean change from baseline in BCVA to Week 40 based on the Early Treatment Diabetic Retinopathy Study (ETDRS) score (40 weeks)

NCT04514653 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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