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NCT04844619Active, not recruitingPhase 1

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

Evaluation of Effectiveness of KDR2-2 Suspension Eyedrop on Neovascular Regression in the Treatment of Neovascular Glaucoma: an Exploratory Clinical Trial

Source: ClinicalTrials.gov · Last updated 11 Dec 2024

Brief summary (registry, in English)

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 (registry)
Active, not recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
40 (estimated)
First submitted
13 Apr 2021
Start date
Apr 2021
Primary completion date
Dec 2024
Lead sponsor
Sun Yat-sen University
Diseases
Glaucoma
NCT number
NCT04844619

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 40
  • From Apr 2021 to the primary completion date, Dec 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Intravitreal injection of anti-VEGF drugs within 3 month before enrollment;
  • Those who plan to receive ocular surgery during the follow-up period;

Other illness

  • Suffering from other ocular diseases that affect ocular examinations (e.g. keratopathy, uveitis, intraocular infection, etc.);
  • 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.);

Other

  • Participation in other clinical trials within 1 month;
  • Premenopausal women without birth control;

Who the study is looking for

  • 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;

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Zhongshan Ophthalmic Center
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.