Corneal NeovascularisationFND-CNVNCT07642960
Fine-needle Diathermy Combined With Subconjunctival Bevacizumab for Corneal Neovascularization
A study testing Fine-needle diathermy and Bevacizumab in people with Corneal Neovascularisation, run by HoChiMinh City Eye Hospital at 1 site in Vietnam.
Trial summary
The goal of this clinical trial is to evaluate the efficacy and safety of combined fine-needle diathermy and subconjunctival Bevacizumab injection in patients with corneal neovascularization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corneal Neovascularisation
- What is being tested?
- Fine-needle diathermy and Bevacizumab
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Apr 2026to 1 Apr 2028
- Phase
- Interventional
- 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
- Age over 18 years.
- Diagnosis of corneal neovascularization involving at least one quadrant of the cornea, confirmed by slit-lamp examination.
- Corneal neovascularization is stable with no evidence of progression for at least 4 weeks.
- Agreement to participate in the study and ability to comply with outpatient follow-up requirements
Who cannot join
- Pregnant or breastfeeding women.
- History of hypersensitivity or allergy to bevacizumab or any component of the study medication.
- Presence of severe systemic disease that would preclude study participation or surgical intervention, including coagulation disorders or uncontrolled cardiovascular disease.
- Active ocular infection or acute conjunctivitis at the time of enrollment.
- Persistent corneal epithelial defect or delayed corneal epithelial healing.
- History of ocular surgery within 3 months before study enrollment.
- Corneal neovascularization associated with uncontrolled secondary glaucoma.
- Inability or unwillingness to comply with study treatment or follow-up visits.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
HoChiMinh City Eye Hospital
Ho Chi Minh City, Xuan Hoa, 72400
Minh Nhat Le, MD,MSc, +84833399368, le.nminh93@gmail.com
About this study
Official title: Evaluation of Combined Fine-needle Diathermy and Subconjunctival Bevacizumab Injection in the Treatment of Corneal Neovascularization
The goal of this clinical trial is to evaluate the efficacy and safety of combined fine-needle diathermy and subconjunctival Bevacizumab injection in patients with corneal neovascularization.
The main questions it aims to answer are:
Read more
Does combined fine-needle diathermy and subconjunctival Bevacizumab injection promote regression of corneal neovascularization? Is the treatment safe and well tolerated by patients?
Participants will:
Undergo a baseline evaluation, including assessment of disease duration, ocular history, systemic medical history, and presenting symptoms.
Undergo a detailed ophthalmic evaluation, including best-corrected visual acuity, intraocular pressure measurement, slit-lamp examination, corneal photography, and anterior segment optical coherence tomography (AS-OCT). Provide informed consent after explanation of potential risks and benefits of the procedure.
Read the detailed description
- Background and Rationale Corneal neovascularization (CNV) is a pathological condition characterized by the ingrowth of blood vessels from the limbal vascular plexus into the normally avascular cornea. CNV has various etiologies, including infectious keratitis, inflammatory ocular surface diseases, trauma, chemical injury, contact lens-related complications, limbal stem cell deficiency, and other corneal disorders. The presence of corneal neovascularization can affect corneal transparency, induce lipid deposition and scarring, reduce visual acuity, and increase the risk of corneal graft rejection. Many treatment modalities have been used to manage CNV, including topical corticosteroids, laser photocoagulation, anti-vascular endothelial growth factor (anti-VEGF) therapy, and fine-needle diathermy (FND). Fine-needle diathermy directly occludes established corneal blood vessels and has demonstrated effectiveness in reducing mature corneal neovascularization. Bevacizumab, a monoclonal antibody against vascular endothelial growth factor (VEGF), inhibits angiogenesis and may reduce the formation and recurrence of corneal neovessels. The combination of FND and subconjunctival bevacizumab injection may provide a synergistic therapeutic effect by targeting both existing vessels and VEGF-mediated angiogenesis. Although both fine-needle diathermy and bevacizumab have been used individually in the treatment of corneal neovascularization, there is currently limited evidence regarding the long-term efficacy and safety of combining these two treatment modalities. Most published studies have involved small sample sizes, short follow-up periods, or have focused primarily on the outcomes of either fine-needle diathermy or anti-VEGF therapy alone.
- Objectives Primary objective: to evaluate corneal neovascularization regression at 12 months after combined fine-needle diathermy and subconjunctival Bevacizumab injection. Secondary Objective: to assess the visual acuity, corneal clarity, recurrence of neovascularization, and treatment-related adverse events.
- Study design: This is a prospective, single-arm, interventional clinical trial conducted at the Cornea Department of HoChiMinh City Eye Hospital. This study will enroll a total of 51 eyes. The study period spans from April 2026 to April 2028, including a 12-month follow-up for each participant.
- Participants Eligible Participants are adults aged > 18 years with a diagnosis of corneal neovascularization involving at least one quadrant of the cornea, confirmed by slit-lamp examination Corneal neovascularization is stable with no evidence of progression for at least 4 weeks.
- Surgical technique: The corneal neovascularization is identified under an operating microscope. A curved 10-0 nylon needle is inserted into the corneal stroma, with the needle oriented either parallel or perpendicular to the neovessel, depending on the vessel location and surgical accessibility. The target blood vessels are cauterized through a 10-0 nylon needle using low-power monopolar diathermy (1-2 mA). Diathermy is applied for approximately 1-2 seconds and discontinued once mild focal corneal stromal whitening or edema is observed, and the neovessels demonstrate visible contraction. After that, the needle is removed from the corneal stroma, and a subconjunctival injection of Bevacizumab (2.5mg/0.1ml) is injected into the subconjunctival space adjacent to the limbus.
- Follow-up Protocol: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and 12 months after treatment. At each visit, the following will be assessed: Best-corrected visual acuity, intraocular pressure, ocular surface examination, corneal photography, and recording of treatment-related adverse events.
- Outcome Measures Primary outcome: Percentage reduction in corneal neovascularization area at 12 months. Corneal photographs will be obtained at baseline and follow-up visits. The neovascularized corneal area will be measured using ImageJ software. The primary outcome is the percentage reduction in corneal neovascularization area at 12 months compared with baseline. Secondary outcomes: Change in best-corrected visual acuity, corneal clarity, and recurrence of corneal neovascularization after treatment. Rates of postoperative complications: pain, subconjunctival hemorrhage, corneal epithelial defects, corneal edema, and other ocular complications.
- Data Collection and Management All data will be recorded in standardized case report forms and entered into a secure electronic database. Data quality will be reviewed regularly by the study monitoring committee.
- Statistical Analysis Descriptive statistics will be used to summarize demographics and baseline characteristics. Differences between groups will be assessed using: Student's t-test for continuous variables, Chi-square or Fisher's exact test for categorical outcomes, Kaplan-Meier survival analysis for surgical success, P-values <0.05 considered statistically significant.
- Safety considerations Experienced cornea surgeons will perform all surgical procedures. Standard aseptic and surgical safety protocols will be followed. Any serious adverse event (SAE) will be reported to the Institutional Review Board (IRB) and the study monitoring committee.
- Significance of the study This is the first prospective clinical study in Vietnam to evaluate the long-term outcomes of combined fine-needle diathermy and subconjunctival bevacizumab injection for corneal neovascularization. The findings may provide evidence to support the effectiveness and safety of this combined approach, contribute to the development of treatment recommendations, and improve clinical management of patients with corneal neovascularization.
- Conditions
- Corneal Neovascularisation
- Being tested
- Fine-needle diathermy, Bevacizumab
- Keywords
- Corneal Neovascularization, Fine-Needle Diathermy, Anti-VEGF
- Medical subject headings
- Corneal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fine-needle diathermyProcedure or surgery
Fine-needle diathermy is performed under an operating microscope using a 10-0 nylon needle and low-power monopolar diathermy to occlude corneal neovessels.
BevacizumabDrug
Bevacizumab 2.5 mg/0.1 mL is administered by subconjunctival injection adjacent to the treated corneal neovessels immediately after fine-needle diathermy.
| Study group | Role | What they receive |
|---|---|---|
| Fine-needle diathermy plus subconjunctival Bevacizumab | Experimental | Participants with corneal neovascularization will receive combined fine-needle diathermy and subconjunctival bevacizumab injection. Fine-needle diathermy will be performed to occlude corneal neovessels, followed by a subconjunctival injection of bevacizumab (2.5 mg/0.1 mL) adjacent to the treated area. Participants will be followed for 12 months to evaluate treatment efficacy and safety. Receives: Procedure: Fine-needle diathermy; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage reduction in corneal neovascularization area at 12 months
Corneal photographs will be obtained at baseline and follow-up visits. The neovascularized corneal area will be measured using ImageJ software. The primary outcome is the percentage reduction in corneal neovascularization area at 12 months compared with baseline following combined fine-needle diathermy and subconjunctival bevacizumab injection.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start1 Apr 2026
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal NeovascularisationStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HoChiMinh City Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Le Nhat Minh, HoChiMinh City Eye Hospital
- Investigators
- Minh Nhat Le, Master of Ophthalmology, Principal investigator, HoChiMinh City Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07642960
- Sponsor's protocol ID
- CS/BVM/25/84
- Acronym
- FND-CNV
- Status last verified
- Jun 2026
- First submitted
- 6 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Combined Fine-needle Diathermy and Subconjunctival Bevacizumab Injection in the Treatment of Corneal Neovascularization
- ClinicalTrials.gov ID
- NCT07642960
- Acronym / sponsor ID
- FND-CNV / CS/BVM/25/84
- Conditions
- Corneal Neovascularisation
- Keywords
- Corneal Neovascularization, Fine-Needle Diathermy, Anti-VEGF
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- HoChiMinh City Eye HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 11 Jun 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.
The goal of this clinical trial is to evaluate the efficacy and safety of combined fine-needle diathermy and subconjunctival Bevacizumab injection in patients with corneal neovascularization.
The main questions it aims to answer are:
Does combined fine-needle diathermy and subconjunctival Bevacizumab injection promote regression of corneal neovascularization? Is the treatment safe and well tolerated by patients?
Participants will:
Undergo a baseline evaluation, including assessment of disease duration, ocular history, systemic medical history, and presenting symptoms.
Undergo a detailed ophthalmic evaluation, including best-corrected visual acuity, intraocular pressure measurement, slit-lamp examination, corneal photography, and anterior segment optical coherence tomography (AS-OCT). Provide informed consent after explanation of potential risks and benefits of the procedure.
Detailed description
- Background and Rationale Corneal neovascularization (CNV) is a pathological condition characterized by the ingrowth of blood vessels from the limbal vascular plexus into the normally avascular cornea. CNV has various etiologies, including infectious keratitis, inflammatory ocular surface diseases, trauma, chemical injury, contact lens-related complications, limbal stem cell deficiency, and other corneal disorders. The presence of corneal neovascularization can affect corneal transparency, induce lipid deposition and scarring, reduce visual acuity, and increase the risk of corneal graft rejection. Many treatment modalities have been used to manage CNV, including topical corticosteroids, laser photocoagulation, anti-vascular endothelial growth factor (anti-VEGF) therapy, and fine-needle diathermy (FND). Fine-needle diathermy directly occludes established corneal blood vessels and has demonstrated effectiveness in reducing mature corneal neovascularization. Bevacizumab, a monoclonal antibody against vascular endothelial growth factor (VEGF), inhibits angiogenesis and may reduce the formation and recurrence of corneal neovessels. The combination of FND and subconjunctival bevacizumab injection may provide a synergistic therapeutic effect by targeting both existing vessels and VEGF-mediated angiogenesis. Although both fine-needle diathermy and bevacizumab have been used individually in the treatment of corneal neovascularization, there is currently limited evidence regarding the long-term efficacy and safety of combining these two treatment modalities. Most published studies have involved small sample sizes, short follow-up periods, or have focused primarily on the outcomes of either fine-needle diathermy or anti-VEGF therapy alone.
- Objectives Primary objective: to evaluate corneal neovascularization regression at 12 months after combined fine-needle diathermy and subconjunctival Bevacizumab injection. Secondary Objective: to assess the visual acuity, corneal clarity, recurrence of neovascularization, and treatment-related adverse events.
- Study design: This is a prospective, single-arm, interventional clinical trial conducted at the Cornea Department of HoChiMinh City Eye Hospital. This study will enroll a total of 51 eyes. The study period spans from April 2026 to April 2028, including a 12-month follow-up for each participant.
- Participants Eligible Participants are adults aged > 18 years with a diagnosis of corneal neovascularization involving at least one quadrant of the cornea, confirmed by slit-lamp examination Corneal neovascularization is stable with no evidence of progression for at least 4 weeks.
- Surgical technique: The corneal neovascularization is identified under an operating microscope. A curved 10-0 nylon needle is inserted into the corneal stroma, with the needle oriented either parallel or perpendicular to the neovessel, depending on the vessel location and surgical accessibility. The target blood vessels are cauterized through a 10-0 nylon needle using low-power monopolar diathermy (1-2 mA). Diathermy is applied for approximately 1-2 seconds and discontinued once mild focal corneal stromal whitening or edema is observed, and the neovessels demonstrate visible contraction. After that, the needle is removed from the corneal stroma, and a subconjunctival injection of Bevacizumab (2.5mg/0.1ml) is injected into the subconjunctival space adjacent to the limbus.
- Follow-up Protocol: Participants will be followed at 1 week, 1 month, 3 months, 6 months, and 12 months after treatment. At each visit, the following will be assessed: Best-corrected visual acuity, intraocular pressure, ocular surface examination, corneal photography, and recording of treatment-related adverse events.
- Outcome Measures Primary outcome: Percentage reduction in corneal neovascularization area at 12 months. Corneal photographs will be obtained at baseline and follow-up visits. The neovascularized corneal area will be measured using ImageJ software. The primary outcome is the percentage reduction in corneal neovascularization area at 12 months compared with baseline. Secondary outcomes: Change in best-corrected visual acuity, corneal clarity, and recurrence of corneal neovascularization after treatment. Rates of postoperative complications: pain, subconjunctival hemorrhage, corneal epithelial defects, corneal edema, and other ocular complications.
- Data Collection and Management All data will be recorded in standardized case report forms and entered into a secure electronic database. Data quality will be reviewed regularly by the study monitoring committee.
- Statistical Analysis Descriptive statistics will be used to summarize demographics and baseline characteristics. Differences between groups will be assessed using: Student's t-test for continuous variables, Chi-square or Fisher's exact test for categorical outcomes, Kaplan-Meier survival analysis for surgical success, P-values <0.05 considered statistically significant.
- Safety considerations Experienced cornea surgeons will perform all surgical procedures. Standard aseptic and surgical safety protocols will be followed. Any serious adverse event (SAE) will be reported to the Institutional Review Board (IRB) and the study monitoring committee.
- Significance of the study This is the first prospective clinical study in Vietnam to evaluate the long-term outcomes of combined fine-needle diathermy and subconjunctival bevacizumab injection for corneal neovascularization. The findings may provide evidence to support the effectiveness and safety of this combined approach, contribute to the development of treatment recommendations, and improve clinical management of patients with corneal neovascularization.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fine-needle diathermy plus subconjunctival Bevacizumab | Experimental | Procedure: Fine-needle diathermy, Drug: BevacizumabParticipants with corneal neovascularization will receive combined fine-needle diathermy and subconjunctival bevacizumab injection. Fine-needle diathermy will be performed to occlude corneal neovessels, followed by a subconjunctival injection of bevacizumab (2.5 mg/0.1 mL) adjacent to the treated area. Participants will be followed for 12 months to evaluate treatment efficacy and safety. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age over 18 years.
- Diagnosis of corneal neovascularization involving at least one quadrant of the cornea, confirmed by slit-lamp examination.
- Corneal neovascularization is stable with no evidence of progression for at least 4 weeks.
- Agreement to participate in the study and ability to comply with outpatient follow-up requirements
Key exclusion criteria (8 listed)
- Pregnant or breastfeeding women.
- History of hypersensitivity or allergy to bevacizumab or any component of the study medication.
- Presence of severe systemic disease that would preclude study participation or surgical intervention, including coagulation disorders or uncontrolled cardiovascular disease.
- Active ocular infection or acute conjunctivitis at the time of enrollment.
- Persistent corneal epithelial defect or delayed corneal epithelial healing.
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 |
|---|---|---|
| Fine-needle diathermyFine-needle diathermy is performed under an operating microscope using a 10-0 nylon needle and low-power monopolar diathermy to occlude corneal neovessels. | Procedure or surgery | Fine-needle diathermy plus subconjunctival Bevacizumab |
| BevacizumabBevacizumab 2.5 mg/0.1 mL is administered by subconjunctival injection adjacent to the treated corneal neovessels immediately after fine-needle diathermy. | Drug | Fine-needle diathermy plus subconjunctival Bevacizumab |
Primary outcome
Percentage reduction in corneal neovascularization area at 12 months
Time frame: 12 months
Corneal photographs will be obtained at baseline and follow-up visits. The neovascularized corneal area will be measured using ImageJ software. The primary outcome is the percentage reduction in corneal neovascularization area at 12 months compared with baseline following combined fine-needle diathermy and subconjunctival bevacizumab injection.
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 11 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Corneal Neovascularisation
RecruitingPhase 2/3
Corneal Crosslinking for Treatment of Corneal Neovascularization
Corneal Neovascularization
RecruitingPhase 1/2
Clinical Study of Intrastromal Anti-VEGF Injection for Corneal Neovascularization.
Herpes Simplex Keratitis, Corneal Neovascularization
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.
Minh Nhat Le, Master of Ophthalmology principal investigator
HoChiMinh City Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fine-needle diathermy and Bevacizumab in people with Corneal Neovascularisation, run by HoChiMinh City Eye Hospital at 1 site in Vietnam.
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 4 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 11 Jun 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 Vietnam. 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.
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 Minh Nhat Le, Master of Ophthalmology (+84833399368, le.nminh93@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage reduction in corneal neovascularization area at 12 months (time frame: 12 months). 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 11 Jun 2026.