Clinical trial NCT04844619: KDR2-2 Suspension Eyedrop in the Treatment of Neovascular Glaucoma (KDR-NVG) Trial
Official title: Evaluation of Effectiveness of KDR2-2 Suspension Eyedrop on Neovascular Regression in the Treatment of Neovascular Glaucoma: an Exploratory Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Neovascular Glaucoma
Neovascularization
Keywords: Neovascular Glaucoma
Neovascularization
anti-VEGF
vascular endothelial growth factor
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-04-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.);

Primary outcomes:
measure: Changes of iris neovascularization
timeFrame: Day 0 and 7
Secondary outcomes:
measure: Intraocular pressure
timeFrame: Day 0，7 and 28
measure: Best-corrected visual acuity
timeFrame: Day 0，7 and 28
measure: Adverse events
timeFrame: Day 0，7 and 28
measure: Changes of iris neovascularization
timeFrame: Day 0，7 and 28
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Xiulan Zhang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: