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Recruiting NCT07329686

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

Phase I / Phase II Interventional Herpes Simplex Keratitis Corneal Neovascularization

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intrastromal anti-VEGF injection and topical antiviral eye drops, Conventional antiviral topical ocular drops..
Who it may be relevant to
Registry conditions: Herpes Simplex Keratitis, Corneal Neovascularization. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

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

Primary outcome measures

  • Change in Neovascularization Area [Time frame: 1、2、4、8、12 week]
  • Corneal Clarity Score [Time frame: 1、2、4、8、12 week]
  • Best Corrected Visual Acuity (BCVA) [Time frame: 1、2、4、8、12 week]
  • Conjunctival Hyperemia Score [Time frame: 1、2、4、8、12 week]
  • Corneal Endothelial Cell Count [Time frame: 1、2、4、8、12 week]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • 1 Xihu Avenue, Shangcheng District,Hangzhou, Zhejiang,China,Hangzhou, Zhejiang Completed — Hangzhou

Identifiers

NCT: NCT07329686 · 2025-0998

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗