Clinical Study of Intrastromal Anti-VEGF Injection for Corneal Neovascularization.

Corneal stromal injection is an emerging local drug delivery method, characterized by strong targeting, high drug concentration, and prolonged duration of action. It has been preliminarily applied in the treatment of fungal keratitis and neurotrophic corneal diseases. This study aims to investigate the safety and efficacy of anti-VEGF drugs delivered via corneal stromal injection in neovascularization caused by HSK (Herpes Simplex Keratitis). The study has clear medical significance and technical feasibility, and it is expected to promote innovation in the treatment paradigm for corneal neovascularization.

Study Overview

• Status: Recruiting
• Conditions: Corneal Neovascularization; Herpes Simplex Keratitis
• Intervention / Treatment: Drug: Intrastromal anti-VEGF injection and topical antiviral eye drops; Drug: Conventional antiviral topical ocular drops.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Xiuming Jin; Phone Number: 8613989455778; Email: lzyjxm@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • 1 Xihu Avenue, Shangcheng District,Hangzhou, Zhejiang,China,Hangzhou, Zhejiang Completed
      • Contact: Xiuming Jin; Phone Number: 8613989455778; Email: lzyjxm@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis: Patients who meet the diagnostic criteria for Herpes Simplex Virus (HSV) keratitis with neovascularization.
• Age: Adults aged 18 years or older.
• Previous Treatment: Patients who have not undergone other anti-VEGF treatments or corneal surgeries.
• Informed Consent: Patients who are capable of understanding and signing an informed consent form, agreeing to participate in the entire study process and to follow the study's follow-up schedule and treatment plan.
• Other: Additional criteria as deemed necessary by the investigator.

Exclusion Criteria:

• Risk of Corneal Perforation: Patients at risk of corneal perforation.
• Severe Ocular Surface Dryness: Patients with severe dry eye syndrome.
• Systemic Diseases: Patients with systemic diseases that may affect the nervous or immune systems, such as diabetes, rheumatoid arthritis, autoimmune diseases, etc.
• Recent Use of Systemic Immunosuppressants: Patients who have recently used systemic immunosuppressive agents.
• Poor Compliance: Patients who are unable to follow up on time or adhere to the treatment plan.
• Pregnancy or Lactation: Pregnant or nursing women, as their physiological state may affect study outcomes.
• Allergy History: Patients with a history of allergies to the study medication or related components.
• Other Reasons: Patients deemed by the investigator to have other reasons making them unsuitable for participation in the trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; The experimental group received intrastromal corneal injections of anti-VEGF (Vascular Endothelial Growth Factor) medication in conjunction with antiviral medication therapy.	Drug: Intrastromal anti-VEGF injection and topical antiviral eye drops; The experimental group received intrastromal corneal injections of anti-VEGF (Vascular Endothelial Growth Factor) medication in conjunction with antiviral medication therapy
Active Comparator: Control group; The control group was treated with conventional antiviral topical ocular drops.	Drug: Conventional antiviral topical ocular drops.; The control group was treated with conventional antiviral topical ocular drops.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Neovascularization Area	1、2、4、8、12 week
Corneal Clarity Score	1、2、4、8、12 week
Best Corrected Visual Acuity (BCVA)	1、2、4、8、12 week
Conjunctival Hyperemia Score	1、2、4、8、12 week
Corneal Endothelial Cell Count	1、2、4、8、12 week

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: December 7, 2025
• First Submitted That Met QC Criteria: January 6, 2026
• First Posted (Actual): January 9, 2026

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: corneal neovascularization; Herpes Simplex Keratitis
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Virus Diseases; Eye Diseases; DNA Virus Infections; Corneal Diseases; Herpesviridae Infections; Keratitis; Metaplasia; Eye Infections; Neovascularization, Pathologic; Herpes Simplex; Eye Infections, Viral; Pathological Conditions, Signs and Symptoms; Keratitis, Herpetic; Corneal Neovascularization
• Other Study ID Numbers: 2025-0998

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No