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

NCT04844619 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: 2021KYPJ080
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Neovascular Glaucoma; Neovascularization

Keywords

Neovascular Glaucoma; Neovascularization; anti-VEGF; vascular endothelial growth factor

Outcome Measures

Primary Outcomes (1)

• Changes of iris neovascularization

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

  Day 0 and 7

Secondary Outcomes (4)

• Intraocular pressure

  Day 0，7 and 28

• Best-corrected visual acuity

  Day 0，7 and 28

• Adverse events

  Day 0，7 and 28

• Changes of iris neovascularization

  Day 0，7 and 28

Study Arms (1)

KDR2-2 group

EXPERIMENTAL

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

4mg/ml KDR2-2 suspension eyedrop DRUG

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 group

16mg/ml KDR2-2 suspension eyedrop DRUG

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

KDR2-2 group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.);

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 51000, China

Location

MeSH Terms

Conditions

Glaucoma, Neovascular; Neovascularization, Pathologic

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiulan Zhang, MD, PhD

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Ophthalmology, Director of Clinical Research Center, Director of CFDA-certified Pharmaceutical Research Unit, State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 14, 2021
• Study Start: April 19, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)