KDR2-2 Suspension Eyedrop in the Treatment of Neovascular Glaucoma (KDR-NVG) Trial

Phase 1

Active, not recruiting

• Conditions: Neovascular Glaucoma; Neovascularization
• Interventions: Drug: 4mg/ml KDR2-2 suspension eyedrop; Drug: 16mg/ml KDR2-2 suspension eyedrop

• Registration Number: NCT04844619
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-04-13
• Study First Submitted QC: 2021-04-13
• Study First Posted: 2021-04-14
• Study Start: 2021-04-19
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-11
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age 18-75;
• 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

• Intravitreal injection of anti-VEGF drugs within 3 month before enrollment;
• 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.);

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
KDR2-2 group	4mg/ml KDR2-2 suspension eyedrop	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.
KDR2-2 group	16mg/ml KDR2-2 suspension eyedrop	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.

Primary Outcome Measures

Name	Time	Method
Changes of iris neovascularization	Day 0 and 7	Changes of the iris neovascularization using anterior photography or anterior optical coherence tomography angiography.

Secondary Outcome Measures

Name	Time	Method
Changes of iris neovascularization	Day 0，7 and 28	Changes of the iris neovascularization using anterior photography or anterior optical coherence tomography angiography.
Intraocular pressure	Day 0，7 and 28	Measurement of intraocular pressure using non-contact tonometer or iCare tonometer
Best-corrected visual acuity	Day 0，7 and 28	Measurement of best-corrected visual acuity with Snellen LogMAR Chart
Adverse events	Day 0，7 and 28	Adverse events related with the anti-angiogenic effect of KDR2-2

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center; 🇨🇳 Guangzhou, Guangdong, China