KDR2-2 Suspension Eyedrop in the Treatment of Neovascular Glaucoma (KDR-NVG) Trial (KDR-NVG)
Primary Purpose
Neovascular Glaucoma, Neovascularization
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
4mg/ml KDR2-2 suspension eyedrop
16mg/ml KDR2-2 suspension eyedrop
Sponsored by
About this trial
This is an interventional treatment trial for Neovascular Glaucoma focused on measuring Neovascular Glaucoma, Neovascularization, anti-VEGF, vascular endothelial growth factor
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.);
Sites / Locations
- Zhongshan Ophthalmic CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
KDR2-2 group
Arm Description
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.
Outcomes
Primary Outcome Measures
Changes of iris neovascularization
Changes of the iris neovascularization using anterior photography or anterior optical coherence tomography angiography.
Secondary Outcome Measures
Intraocular pressure
Measurement of intraocular pressure using non-contact tonometer or iCare tonometer
Best-corrected visual acuity
Measurement of best-corrected visual acuity with Snellen LogMAR Chart
Adverse events
Adverse events related with the anti-angiogenic effect of KDR2-2
Changes of iris neovascularization
Changes of the iris neovascularization using anterior photography or anterior optical coherence tomography angiography.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04844619
Brief Title
KDR2-2 Suspension Eyedrop in the Treatment of Neovascular Glaucoma (KDR-NVG) Trial
Acronym
KDR-NVG
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
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 19, 2021 (Actual)
Primary Completion Date
January 31, 2022 (Anticipated)
Study Completion Date
February 28, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovascular Glaucoma, Neovascularization
Keywords
Neovascular Glaucoma, Neovascularization, anti-VEGF, vascular endothelial growth factor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
KDR2-2 group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
4mg/ml KDR2-2 suspension eyedrop
Other Intervention Name(s)
Low-dose KDR2-2
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
16mg/ml KDR2-2 suspension eyedrop
Other Intervention Name(s)
High-dose KDR2-2
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes of iris neovascularization
Description
Changes of the iris neovascularization using anterior photography or anterior optical coherence tomography angiography.
Time Frame
Day 0 and 7
Secondary Outcome Measure Information:
Title
Intraocular pressure
Description
Measurement of intraocular pressure using non-contact tonometer or iCare tonometer
Time Frame
Day 0,7 and 28
Title
Best-corrected visual acuity
Description
Measurement of best-corrected visual acuity with Snellen LogMAR Chart
Time Frame
Day 0,7 and 28
Title
Adverse events
Description
Adverse events related with the anti-angiogenic effect of KDR2-2
Time Frame
Day 0,7 and 28
Title
Changes of iris neovascularization
Description
Changes of the iris neovascularization using anterior photography or anterior optical coherence tomography angiography.
Time Frame
Day 0,7 and 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.);
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiulan Zhang, MD, PhD
Phone
+862066610720
Email
zhangxl2@mail.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiulan Zhang, MD, PhD
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan Ophthalmic Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
51000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiulan Zhang, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
KDR2-2 Suspension Eyedrop in the Treatment of Neovascular Glaucoma (KDR-NVG) Trial
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