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

NCT07329686 | Recruiting Phase 1

• 1 other identifier: 2025-0998
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Herpes Simplex Keratitis; Corneal Neovascularization

Keywords

Herpes Simplex Keratitis; corneal neovascularization

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

The control group was treated with conventional antiviral topical ocular drops.

Drug: Conventional antiviral topical ocular drops.

Interventions

Intrastromal anti-VEGF injection and topical antiviral eye drops DRUG

The experimental group received intrastromal corneal injections of anti-VEGF (Vascular Endothelial Growth Factor) medication in conjunction with antiviral medication therapy

Experimental group

Conventional antiviral topical ocular drops. DRUG

The control group was treated with conventional antiviral topical ocular drops.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

1 Xihu Avenue, Shangcheng District,Hangzhou, Zhejiang,China,Hangzhou, Zhejiang Completed

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Keratitis, Herpetic; Corneal Neovascularization

Condition Hierarchy (Ancestors)

Eye Infections, Viral; Eye Infections; Infections; Herpes Simplex; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Keratitis; Corneal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xiuming Jin

CONTACT

8613989455778; lzyjxm@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: January 9, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 9, 2026

Record last verified: 2025-10

Locations

CN (1)