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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of iris neovascularization | Changes of the iris neovascularization using anterior photography or anterior optical coherence tomography angiography. | Day 0 and 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular pressure | Measurement of intraocular pressure using non-contact tonometer or iCare tonometer | Day 0,7 and 28 |
| Best-corrected visual acuity | Measurement of best-corrected visual acuity with Snellen LogMAR Chart |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiulan Zhang, MD, PhD | Zhongshan Ophthalmic Center, Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Ophthalmic Center | Guangzhou | Guangdong | 51000 | China |
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| ID | Term |
|---|---|
| D015355 | Glaucoma, Neovascular |
| D009389 | Neovascularization, Pathologic |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D008679 | Metaplasia |
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| 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. |
|
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| Day 0,7 and 28 |
| Adverse events | Adverse events related with the anti-angiogenic effect of KDR2-2 | Day 0,7 and 28 |
| Changes of iris neovascularization | Changes of the iris neovascularization using anterior photography or anterior optical coherence tomography angiography. | Day 0,7 and 28 |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |