Clinical Study of Intrastromal Anti-VEGF Injection for Corneal Neovascularization. (NCT07329686) | Clinical Trial Compass
RecruitingPhase 1/2
Clinical Study of Intrastromal Anti-VEGF Injection for Corneal Neovascularization.
China100 participantsStarted 2025-10-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Neovascularization Area
Timeframe: 1、2、4、8、12 week
2
Corneal Clarity Score
Timeframe: 1、2、4、8、12 week
3
Best Corrected Visual Acuity (BCVA)
Timeframe: 1、2、4、8、12 week
4
Conjunctival Hyperemia Score
Timeframe: 1、2、4、8、12 week
5
Corneal Endothelial Cell Count
Timeframe: 1、2、4、8、12 week
Trial details
NCT IDNCT07329686
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University