Primary outcomes of the VIDI study: phase 2, double-masked, randomized, active-controlled study of ASP8232 for diabetic macular edema

International Journal of Retina and Vitreous
Quan Dong NguyenVIDI Research Group

Abstract

ASP8232 is a potent and specific small molecule vascular adhesion protein-1 (VAP-1) inhibitor. This study evaluated the effect of ASP8232 on excess retinal thickness when given alone or in combination with ranibizumab in patients with center-involved diabetic macular edema (CI-DME). This was a phase 2a, placebo and sham-injection controlled, double-masked, randomized, parallel-group clinical trial. Participants were patients with CI-DME and central subfield thickness (CST) ≥ 375 µm in the study eye as assessed by spectral domain optical coherence tomography. Eligible patients were randomized to (1) daily oral ASP8232 40 mg monotherapy; (2) combination therapy of daily oral ASP8232 40 mg and monthly intravitreal ranibizumab 0.3 mg; or (3) monthly intravitreal ranibizumab 0.3 mg monotherapy. The treatment period was 12 weeks. CST and best corrected visual acuity (BCVA) were assessed at baseline and at Weeks 2, 4, 8, 12, 16 and 24. The primary outcome was the mean percent change from baseline in excess CST at Week 12. Secondary outcomes were BCVA, safety and tolerability, and pharmacokinetic and pharmacodynamic characteristics of ASP8232. After 12 weeks, the mean (95% confidence interval) percent change in excess CST was 11.4% (- ...Continue Reading

References

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Citations

Mar 18, 2020·Molecules : a Journal of Synthetic Chemistry and Natural Product Chemistry·Serhii VakalTiina A Salminen
Oct 23, 2020·Biomedicines·Yohei TomitaToshihide Kurihara
Apr 4, 2021·International Journal of Molecular Sciences·Hidetaka NomaMasahiko Shimura
Apr 14, 2021·International Journal of Retina and Vitreous·David S BoyerQuan Dong Nguyen

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Methods Mentioned

BETA
deamination

Clinical Trials Mentioned

NCT02218099
NCT02302079
NCT03238963

Software Mentioned

Statistical Analysis Software

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