ArticleInternational journal of retina and vitreous2019
Primary outcomes of the VIDI study: phase 2, double-masked, randomized, active-controlled study of ASP8232 for diabetic macular edema.
Article in International journal of retina and vitreous, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
14 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.
- A systematic review and meta-analysis of the effect of intravitreal VEGF inhibitors on cardiorenal outcomes.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2023Pooled it
- ROBIN: a randomised, double-masked, placebo-controlled Phase IIa study of the AOC3 inhibitor BI 1467335 in diabetic retinopathy.Eye (London, England) · 2024Trial
- Assessing the Safety and Efficacy of Agonistic Monoclonal Antibody against Robo4 versus Ranibizumab in Neovascular Age-Related Macular Degeneration and Diabetic Macular Edema: A Phase I, Open-Label, Multicenter Study.Ophthalmology science · 2026Article
- Novel glycine amides, semicarbazides and fluoroallylamines as inhibitors of the amine oxidase vascular adhesion protein-1 (VAP-1).RSC medicinal chemistry · 2026Article
- Oral therapies for diabetic retinopathy: Addressing an unmet need or a distant prospect?The Journal of international medical research · 2025Review
- The role of VAP-1 in cardiovascular disease: a review.Frontiers in cardiovascular medicine · 2025Review
- Serum vascular adhesion protein-1 is associated with twelve-year risk of incident cancer, cancer mortality, and all-cause mortality: a community-based cohort study.Frontiers in oncology · 2023Article
- Diabetic Macular Edema: Current Understanding, Molecular Mechanisms and Therapeutic Implications.Cells · 2022Review
- Neuroinflammation and neurodegeneration in diabetic retinopathy.Frontiers in aging neuroscience · 2022Review
- Review
- Amine oxidase copper-containing 3 (AOC3) inhibition: a potential novel target for the management of diabetic retinopathy.International journal of retina and vitreous · 2021Review
- Involvement of Cytokines in the Pathogenesis of Diabetic Macular Edema.International journal of molecular sciences · 2021Review
- PPARα Agonist Oral Therapy in Diabetic Retinopathy.Biomedicines · 2020Review
- Human Copper-Containing Amine Oxidases in Drug Design and Development.Molecules (Basel, Switzerland) · 2020Review
Corrections and comments
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Authors and funding
11 authors at 7 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundASP8232 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).
methodsThis 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.
resultsAfter 12 weeks, the mean (95% confidence interval) percent change in excess CST was 11.4% (- 15.0%, 37.8%) in the ASP8232 group, - 61.7% (- 86.1%, - 37.2%) in the ASP8232/ranibizumab group, and - 75.3% (- 94.8%, - 55.8%) in the ranibizumab group. The change from baseline in the two ranibizumab arms was statistically significant (
conclusionsNear complete inhibition of plasma VAP-1 activity with ASP8232 had no effect on CST in patients with CI-DME. Furthermore, combination therapy did not provide additional benefit to treatment with ranibizumab alone, which significantly reduced CST and improved BCVA.
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