Health TrialsbyHealthPanel

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

ConditionsHerpes Simplex KeratitisCorneal Neovascularization
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Experimental groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

Source ClinicalTrials.gov
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