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NCT Number: NCT07329686

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

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

Hangzhou, Zhejiang, China

Location status: Recruiting

Location contact

Xiuming Jin

CONTACT

[email protected]

8613989455778

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Conventional antiviral topical ocular drops.

Drug

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

Primary outcomes

  1. Change in Neovascularization Area

    Time frame: 1、2、4、8、12 week

  2. Corneal Clarity Score

    Time frame: 1、2、4、8、12 week

  3. Best Corrected Visual Acuity (BCVA)

    Time frame: 1、2、4、8、12 week

  4. Conjunctival Hyperemia Score

    Time frame: 1、2、4、8、12 week

  5. Corneal Endothelial Cell Count

    Time frame: 1、2、4、8、12 week

Study contacts

Contact information is provided by the study sponsor or research team.

Xiuming Jin

CONTACT

[email protected]

8613989455778

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 9, 2026
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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