Neovascular Glaucoma Clinical Trial
— KDR-NVGOfficial title:
Evaluation of Effectiveness of KDR2-2 Suspension Eyedrop on Neovascular Regression in the Treatment of Neovascular Glaucoma: an Exploratory Clinical Trial
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | February 28, 2022 |
Est. primary completion date | January 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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.); |
Country | Name | City | State |
---|---|---|---|
China | Zhongshan Ophthalmic Center | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-sen University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes of iris neovascularization | Changes of the iris neovascularization using anterior photography or anterior optical coherence tomography angiography. | Day 0 and 7 | |
Secondary | Intraocular pressure | Measurement of intraocular pressure using non-contact tonometer or iCare tonometer | Day 0,7 and 28 | |
Secondary | Best-corrected visual acuity | Measurement of best-corrected visual acuity with Snellen LogMAR Chart | Day 0,7 and 28 | |
Secondary | Adverse events | Adverse events related with the anti-angiogenic effect of KDR2-2 | Day 0,7 and 28 | |
Secondary | Changes of iris neovascularization | Changes of the iris neovascularization using anterior photography or anterior optical coherence tomography angiography. | Day 0,7 and 28 |
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