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

NCT ID: NCT07329686

Last Updated: 2026-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2026-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Herpes Simplex Keratitis Corneal Neovascularization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental group

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

Group Type EXPERIMENTAL

Intrastromal anti-VEGF injection and topical antiviral eye drops

Intervention Type DRUG

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

Control group

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

Group Type ACTIVE_COMPARATOR

Conventional antiviral topical ocular drops.

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Conventional antiviral topical ocular drops.

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiuming Jin

Role: CONTACT

8613989455778

Facility Contacts

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Xiuming Jin

Role: primary

8613989455778

Other Identifiers

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2025-0998

Identifier Type: -

Identifier Source: org_study_id

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