Neovascular Glaucoma, Neovascularization
Conditions
Keywords
Neovascular Glaucoma, Neovascularization, anti-VEGF, vascular endothelial growth factor
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.
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.
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.
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
* 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.);
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of iris neovascularization | Day 0 and 7 | Changes of the iris neovascularization using anterior photography or anterior optical coherence tomography angiography. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Changes of iris neovascularization | Day 0，7 and 28 | Changes of the iris neovascularization using anterior photography or anterior optical coherence tomography angiography. |
Countries
China
Outcome results
None listed