Herpes Simplex KeratitisPhase 1/2NCT07329686
Clinical Study of Intrastromal Anti-VEGF Injection for Corneal Neovascularization.
A Phase 1/2 study testing Intrastromal anti-VEGF injection and topical antiviral eye drops and Conventional antiviral topical ocular drops. in people with Herpes Simplex Keratitis and Corneal Neovascularization, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Herpes Simplex Keratitis, Corneal Neovascularization
- What is being tested?
- Intrastromal anti-VEGF injection and topical antiviral eye drops and Conventional antiviral topical ocular drops.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to Oct 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
1 Xihu Avenue, Shangcheng District,Hangzhou, Zhejiang,China,Hangzhou, Zhejiang Completed
Hangzhou, Zhejiang
Xiuming Jin, 8613989455778, lzyjxm@zju.edu.cn
About this study
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.
- Being tested
- Intrastromal anti-VEGF injection and topical antiviral eye drops, Conventional antiviral topical ocular drops.
- Keywords
- Herpes Simplex Keratitis, corneal neovascularization
- Medical subject headings
- Keratitis, Herpetic, Corneal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrastromal anti-VEGF injection and topical antiviral eye dropsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The experimental group received intrastromal corneal injections of anti-VEGF (Vascular Endothelial Growth Factor) medication in conjunction with antiviral medication therapy. Receives: Drug: Intrastromal anti-VEGF injection and topical antiviral eye drops |
| Control group | Active comparator | The control group was treated with conventional antiviral topical ocular drops. Receives: Drug: Conventional antiviral topical ocular drops. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Neovascularization Area
Measured: 1、2、4、8、12 week
Corneal Clarity Score
Measured: 1、2、4、8、12 week
Best Corrected Visual Acuity (BCVA)
Measured: 1、2、4、8、12 week
Conjunctival Hyperemia Score
Measured: 1、2、4、8、12 week
Corneal Endothelial Cell Count
Measured: 1、2、4、8、12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start1 Oct 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes Simplex KeratitisStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07329686
- Sponsor's protocol ID
- 2025-0998
- Status last verified
- Oct 2025
- First submitted
- 7 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Intrastromal Anti-VEGF Injection for Corneal Neovascularization.
- ClinicalTrials.gov ID
- NCT07329686
- Acronym / sponsor ID
- 2025-0998
- Keywords
- Herpes Simplex Keratitis, corneal neovascularization
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Intrastromal anti-VEGF injection and topical antiviral eye dropsThe experimental group received intrastromal corneal injections of anti-VEGF (Vascular Endothelial Growth Factor) medication in conjunction with antiviral medication therapy. |
| Control group | Active comparator | Drug: Conventional antiviral topical ocular drops.The control group was treated with conventional antiviral topical ocular drops. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrastromal anti-VEGF injection and topical antiviral eye dropsThe experimental group received intrastromal corneal injections of anti-VEGF (Vascular Endothelial Growth Factor) medication in conjunction with antiviral medication therapy | Drug | Experimental group |
| Conventional antiviral topical ocular drops.The control group was treated with conventional antiviral topical ocular drops. | Drug | Control group |
Primary outcome
Change in Neovascularization Area
Time frame: 1、2、4、8、12 week
Corneal Clarity Score
Time frame: 1、2、4、8、12 week
Best Corrected Visual Acuity (BCVA)
Time frame: 1、2、4、8、12 week
Conjunctival Hyperemia Score
Time frame: 1、2、4、8、12 week
Corneal Endothelial Cell Count
Time frame: 1、2、4、8、12 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
Related trials for Herpes Simplex Keratitis
Active, not recruitingPhase 1
A Study of the Safety, Tolerability and Prelinminary Efficacy of BD111 in Herpes Simplex Virus Type I Stromal Keratitis
Herpes Simplex Virus Type I Stromal Keratitis
RecruitingPhase 2
A Phase Ⅱa Study of the Safety, Tolerability and Efficacy of BD111 in Herpes Simplex Virus Type I Stromal Keratitis
Herpes Simplex Virus Type I Stromal Keratitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Intrastromal anti-VEGF injection and topical antiviral eye drops and Conventional antiviral topical ocular drops. in people with Herpes Simplex Keratitis and Corneal Neovascularization, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiuming Jin (8613989455778, lzyjxm@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Neovascularization Area (time frame: 1、2、4、8、12 week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.