KDR2-2 Suspension Eyedrop in the Treatment of Neovascular Glaucoma (KDR-NVG) Trial
NCT ID: NCT04844619
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
40 participants
INTERVENTIONAL
2021-04-19
2024-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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KDR2-2 group
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.
4mg/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.
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.
Interventions
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4mg/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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The best-corrected visual acuity (BCVA) of the included eyes was \<0.01 (Snellen chart);
* The BCVA of the contralateral eye of the included subjects was \>0.1;
* Patients with clinically diagnosed neovascular glaucoma; The diagnostic criteria for neovascularization glaucoma were as follows: Intraocular pressure \> 21mmHg measured by Goldmann applanation tonometer; Neovascularization is seen in the iris or anterior chamber angle, with or without corneal edema;
* Compliance with follow up for more than 28 days and written informed consent obtained;
Exclusion Criteria
* Participation in other clinical trials within 1 month;
* Suffering from other ocular diseases that affect ocular examinations (e.g. keratopathy, uveitis, intraocular infection, etc.);
* Those who plan to receive ocular surgery during the follow-up period;
* Premenopausal women without birth control;
* Having other systemic diseases such as severe liver and kidney function damage, cardiovascular disorders, respiratory disorders, etc.) that may affect the anti-neovascular effect of KDR2-2 or more likely to develop adverse events ;
* Systemic infections under treatment;
* Any study in which the physician believes that the patient's condition will interfere with the clinical trial (e.g., the patient is prone to stress, mood disorders, depression, etc.);
18 Years
75 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Xiulan Zhang
Professor of Ophthalmology, Director of Clinical Research Center, Director of CFDA-certified Pharmaceutical Research Unit, State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center
Principal Investigators
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Xiulan Zhang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Zhongshan Ophthalmic Center, Sun Yat-sen University
Locations
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Zhongshan Ophthalmic Center
Guangzhou, Guangdong, China
Countries
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Other Identifiers
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2021KYPJ080
Identifier Type: -
Identifier Source: org_study_id