Overview

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

Status:
Recruiting
Trial end date:
2022-02-28
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sun Yat-sen University
Treatments:
Ophthalmic Solutions
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.);