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

Обзор

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.

Вмешательства

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

Первичные конечные точки

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

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

Идентификаторы

NCT: NCT07329686 · 2025-0998

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗