A Phase 1 interventional study of 4mg/ml KDR2-2 suspension eyedrop and 16mg/ml KDR2-2 suspension eyedrop in Neovascular Glaucoma and Neovascularization, sponsored by Sun Yat-sen University. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-12-11.
Sponsored by Sun Yat-sen University · Phase 1, Interventional, and Treatment
The clinical trial is aimed to evaluate the anti-neovascular effect of KDR2-2 suspension eyedrop in the treatment of neovascular glaucoma. Fourty subjects would receive either 0.96 or 3.84 mg/per day/eye, in a QID fashion, ×7 days (those without complications can continue to 28 days). The anti-neovascular effect of KDR2-2 on iris neovascularization would be evaluated at day 1, day 7, day 14, day 28 after KDR2-2 usage.
Neovascular glaucoma (NVG) has a high blinding rate and poor prognosis. Anti-glaucoma surgery is the main stake of saving visual function and relieving pain, but the proliferation of iris neovascularization (NVI) makes it difficult to treat NVG. Normally, the patients need an intravitreal injection of anti-vascular endothelial growth factor (anti-VEGF) agents prior to glaucoma surgery to control the NVI proliferation.
KDR2-2, a novel small-molecule tyrosine kinase inhibitor targeting VEGF receptor 2 (VEGFR2), has demonstrated anti-neovascular effect without obvious side-effects or complications in animal studies and a Phase I clinical trial (NCT04620109). In this study, 40 patients with NVG will be included to evaluate the effectiveness of KDR2-2 suspension eyedrop on NVI in NVG eyes. The included subjects would receive either 0.96 or 3.84 mg/day/eye, in a QID fashion, ×7 days (those without complications can continue to 28 days).
This study aims to and propose a novel, non-invasive and more compliant method for the treatment of NVG.
39 studies on the registry are indexed under Glaucoma, Neovascular; 5 are open to participants now.
This study's planned enrollment of 40 is close to the median of 40 across 32 interventional studies indexed under Glaucoma, Neovascular.
Browse Glaucoma, Neovascular studies →Sun Yat-sen University is the lead sponsor of 1,690 studies on the registry; 619 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The patients with NVG will receive 4.0 mg/ml or 16.0mg/ml KDR2-2 suspension eyedrop and the anti-neovascular effect of KDR2-2 would be evaluated during the follow-up visits.
Drug: 4mg/ml KDR2-2 suspension eyedrop · Drug: 16mg/ml KDR2-2 suspension eyedrop
KDR2-2 is a synthetic anti-angiogenic chemical compound with highly effective inhibition on vascular endothelial growth factor receptor-2 (VEGFR2), and an additional, moderate inhibitory effect on platelet-derived growth factor receptor β (PDGFRβ). KDR2-2 suspension eyedrop is developed for the treatment of iris neovascularization.
Also known as: Low-dose KDR2-2
KDR2-2 is a synthetic anti-angiogenic chemical compound with highly effective inhibition on vascular endothelial growth factor receptor-2 (VEGFR2), and an additional, moderate inhibitory effect on platelet-derived growth factor receptor β (PDGFRβ). KDR2-2 suspension eyedrop is developed for the treatment of iris neovascularization.
Also known as: High-dose KDR2-2
Changes of iris neovascularization
Changes of the iris neovascularization using anterior photography or anterior optical coherence tomography angiography.
Time frame: Day 0 and 7
Intraocular pressure
Measurement of intraocular pressure using non-contact tonometer or iCare tonometer
Time frame: Day 0，7 and 28
Best-corrected visual acuity
Measurement of best-corrected visual acuity with Snellen LogMAR Chart
Time frame: Day 0，7 and 28
Adverse events
Adverse events related with the anti-angiogenic effect of KDR2-2
Time frame: Day 0，7 and 28
Changes of iris neovascularization
Changes of the iris neovascularization using anterior photography or anterior optical coherence tomography angiography.
Time frame: Day 0，7 and 28
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2021 (actual). Primary completion is estimated for Dec 2024, 44 months after the start.
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This study is active, not recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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