Intrastromal anti-VEGF injection for corneal neovascularization

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

We will test whether injecting anti-VEGF medicine into the cornea helps adults with corneal neovascularization caused by herpes simplex keratitis.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT07329686 on ClinicalTrials.gov

What this trial studies

This phase 1/2, single-center interventional trial delivers anti-VEGF directly into the corneal stroma alongside standard topical antiviral drops in adults with neovascularization from herpes simplex keratitis. Participants receive targeted intrastromal injections and are followed at scheduled visits to monitor safety, changes in vessel growth, and visual outcomes compared with conventional topical antiviral therapy. The approach leverages high local drug concentration and prolonged action to limit systemic exposure while tracking ocular adverse events such as infection, inflammation, or corneal integrity issues. The sponsor is the Second Affiliated Hospital, School of Medicine, Zhejiang University, and the protocol focuses on establishing preliminary safety and signals of efficacy.

Who should consider this trial

Good fit: Adults (≥18) with herpes simplex keratitis who have corneal neovascularization, have not previously received anti-VEGF treatment or corneal surgery, and can consent and attend follow-up visits.

Not a fit: Patients at risk of corneal perforation, with severe ocular surface dryness, major systemic immune or nervous system diseases, or recent systemic immunosuppressant use are unlikely to benefit or may be excluded for safety.

Why it matters

Potential benefit: If successful, this targeted injection could reduce corneal blood vessel growth and improve or stabilize vision with fewer systemic side effects.

How similar studies have performed: Intrastromal injections have been used preliminarily for fungal keratitis and neurotrophic corneal disease with promising early results, but intrastromal anti-VEGF for HSK-related neovascularization is relatively novel with limited published data.

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.

Where this trial is running

Hangzhou, Zhejiang

• 1 Xihu Avenue, Shangcheng District,Hangzhou, Zhejiang,China,Hangzhou, Zhejiang Completed — Hangzhou, Zhejiang, China (RECRUITING)

Study contacts

• Study coordinator: Xiuming Jin

Conditions: Herpes Simplex Keratitis, Corneal Neovascularization, corneal neovascularization