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

Zhejiang University

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Herpes Simplex Keratitis; Corneal Neovascularization

Treatments: Drug: Intrastromal anti-VEGF injection and topical antiviral eye drops; Drug: Conventional antiviral topical ocular drops.

Study type: Interventional

Funder types: Other

Identifiers

NCT07329686

2025-0998

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Experimental group

Experimental group

Description:

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

Treatment:

Drug: Intrastromal anti-VEGF injection and topical antiviral eye drops

Control group

Active Comparator group

Description:

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

Treatment:

Drug: Conventional antiviral topical ocular drops.