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Active, not recruitingNCT04844619KDR-NVGUpdated Dec 11, 2024

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

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

Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Neovascular Glaucoma
  • Neovascularization

Keywords

  • Neovascular Glaucoma
  • Neovascularization
  • anti-VEGF
  • vascular endothelial growth factor
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.);
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    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.

    Drug: 4mg/ml KDR2-2 suspension eyedrop · Drug: 16mg/ml KDR2-2 suspension eyedrop

Interventions

  • Drug4mg/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

  • Drug16mg/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: High-dose KDR2-2

05

What researchers measure

Primary outcomes

  1. Changes of iris neovascularization

    Changes of the iris neovascularization using anterior photography or anterior optical coherence tomography angiography.

    Time frame: Day 0 and 7

Secondary outcomes

  1. Intraocular pressure

    Measurement of intraocular pressure using non-contact tonometer or iCare tonometer

    Time frame: Day 0，7 and 28

  2. Best-corrected visual acuity

    Measurement of best-corrected visual acuity with Snellen LogMAR Chart

    Time frame: Day 0，7 and 28

  3. Adverse events

    Adverse events related with the anti-angiogenic effect of KDR2-2

    Time frame: Day 0，7 and 28

  4. 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

06

Study locations

1 site
  • Zhongshan Ophthalmic Center
    Guangzhou, Guangdong 51000, China
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04844619
Lead sponsor
Sun Yat-sen University
Responsible party
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, Sun Yat-sen University) — Principal investigator
First posted
Apr 14, 2021
Start date
Apr 19, 2021
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Dec 11, 2024

Study contacts

Xiulan Zhang, MD, PhD
principal investigator · Zhongshan Ophthalmic Center, Sun Yat-sen University

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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