Corneal NeovascularizationPhase 1/2NCT05011916
The Safety and Efficacy of KDR2-2 Suspension Eye Drops in the Treatment of Corneal Neovascularization
A Phase 1/2 study testing KDR2-2 suspension eye drops in people with Corneal Neovascularization, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 2 sites in China.
Trial summary
KDR2-2, as a tyrosine kinase inhibitor, has a strong inhibitory effect on VEGFR2 and a moderate inhibitory effect on PDGFR-β. It can be used for the treatment of corneal neovascularization. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Corneal Neovascularization
- What is being tested?
- KDR2-2 suspension eye drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- 10 Aug 2021to 9 Aug 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- voluntarily participate in the trial, sign the informed consent form, and follow up according to the time specified by the trial;
- 18~75 years old, without gender limit;
- Superficial or deep corneal progressive neovascularization induced by trauma, chemical burns, corneal transplantation and inflammation: the growth of corneal new vessels≥ 2 mm from the limbus within 1 week to 2 months.
Who cannot join
- Obvious corneal epithelial defects (>1mm), or a history of persistent corneal epithelial defects in the past 3 months (>1mm, ≥14 days);
- Anti-VEGF drugs have been injected locally in the target eye within 3 months, or anti-VEGF drugs have been used systemically within 2 months;
- Recent eye surgery (except for keratoplasty) within 3 months, or planned eye surgery during the trial period;
- Systemic use of glucocorticoid drugs, or intraocular or periocular injection of glucocorticoid drugs within 1 month;
- Contact lenses use within the past 2 weeks (except bandage lenses);
- Stable corneal neovascularization: > 6 months;
Show all 12Show fewer
- History of coagulation abnormalities (such as end-stage liver disease), or current anticoagulant drugs other than aspirin (such as warfarin, heparin, enoxaparin or similar anticoagulants);
- Uncontrolled clinical problems (such as tumors, HIV infection, hepatitis C virus infection, active hepatitis B or other serious chronic infections, serious mental, neurological, cardiovascular, urinary, respiratory and other system diseases, etc.); Uncontrolled hypertension: systolic blood pressure ≥150mmHg or diastolic blood pressure ≥90mmHg; uncontrolled diabetes: A1C>7%;
- Unwillingness/inability to take effective contraceptive measures during the trial period;
- Female subjects have a positive blood pregnancy test;
- Participated in a drug clinical trial within 3 months;
- The investigator believes that it is not suitable for inclusion.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Zhongshan Opthalmic Center
Guangzhou, Guangdong, 510000
Yuan Jin, Professor, 8602087333391, yuanjincornea@126.com
- Recruiting
Zhongshan Ophthalmic Center, Sun Yat-Sen University
Guangzhou, 510060
Qian Wang, MD, 86-018843014719, 419059130@qq.com
Jin Yuan, PHD
About this study
Official title: An Exploratory Clinical Study on the Safety and Efficacy of KDR2-2 Suspension Eye Drops in the Treatment of Corneal Neovascularization
KDR2-2, as a tyrosine kinase inhibitor, has a strong inhibitory effect on VEGFR2 and a moderate inhibitory effect on PDGFR-β. It can be used for the treatment of corneal neovascularization. The main purpose of this study is to explore the efficacy and safety of KDR2-2 suspension eye drops in the treatment of corneal neovascularization. This study is a single-center, prospective, randomized controlled clinical study. A total of 60 patients with corneal neovascularization were enrolled in this study, and they were randomly divided into 4 groups, including the control group, the KDR2-2 low-concentration (4mg/ml) group, the medium-concentration (10mg/ml) group, and the high-concentration (20mg/ml) group, with 15 subjects in each group. The control group applied 0.1% fluorometholone eye drops, and the test groups applied KDR2-2 suspension eye drops with 0.1% fluorometholone eye drops. Patients applied KDR2-2 eye drops four times daily for 6 weeks and were followed up to 10 weeks. The follow-up time points were baseline, 1 week, 2 weeks, 4 weeks, 6 weeks after medication, and 4 weeks after drug withdrawal. Relevant ophthalmological examinations (including visual acuity, intraocular pressure, slit lamp microscopy, central corneal thickness measurement, corneal fluorescein staining assessment, corneal sensitivity measurement, corneal confocal microscope examination, and anterior segment and fundus photography) are performed at each time. And the ocular tolerability score and adverse events of each patient were recorded. By comparative analysis, the efficacy and safety of KDR2-2 eye drops in the treatment of corneal neovascularization were evaluated.
- Conditions
- Corneal Neovascularization
- Being tested
- KDR2-2 suspension eye drops
- Medical subject headings
- Corneal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KDR2-2 suspension eye dropsDrug
All patients were instructed to instill one drop four times per day in the study eye for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Patients in the control group received 0.1% fluorometholone eye drops (0.1% fluorometholone + 0.05% tacrolimus eye drops for patients after corneal transplantation). The patients applied 0.1% fluorometholone eye drops 4 times daily for 10 weeks. Patients were instructed to continue with their usual ophthalmic medication regimens, such as topical antibacterial and antiviral drugs. |
| Low-concentration group | Experimental | Patients in the low-concentration group applied 4mg/ml KDR2-2 suspension eye drops 4 times daily for 6 weeks. The rest of the medication regimen is the same as the control group. Receives: Drug: KDR2-2 suspension eye drops |
| Medium-concentration group | Experimental | Patients in the medium-concentration group applied 4mg/ml KDR2-2 suspension eye drops 4 times daily for 6 weeks. The rest of the medication regimen is the same as the control group. Receives: Drug: KDR2-2 suspension eye drops |
| High-concentration group | Experimental | Patients in the High-concentration group applied 4mg/ml KDR2-2 suspension eye drops 4 times daily for 6 weeks. The rest of the medication regimen is the same as the control group. Receives: Drug: KDR2-2 suspension eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
the changes of the size and extent of corneal neovascularization
The efficacy of KDR2-2 eye drops treatment on corneal neovascularization was evaluated by comparing corneal anterior segment photographs acquired at baseline with photographs acquired on the follow-up visits. Size and extent of CNV was investigated by four primary metrics: (1) neovascular area ratio, the ration of the area of the neovascularization to the area of the cornea, (2) vessel length (VL), the total length of the vessels projected into the cornea, (3) vessel caliber, the mean diameter of the corneal vessels, and (4) Corneal neovascularization progression/stabilization/regression rate
Measured: Baseline, 1 week, 2 weeks, 4 weeks and 6 weeks after medication, and 4 weeks after drug withdrawal
Secondary outcomes (8)
the changes of visual acuity
The uncorrected visual acuity and best corrected visual acuity were assessed through ETDRs chart at baseline and all the follow-up visits. The alterations in visual acuity were evaluated in all patients.
Measured: Baseline, 1 week, 2 weeks, 4 weeks and 6 weeks after medication, and 4 weeks after drug withdrawal
the changes of intraocular pressure
The intraocular pressure of the patients was assessed by iCARE at baseline and all the follow-up visits. The alterations of intraocular pressure were evaluated.
Measured: Baseline, 1 week, 2 weeks, 4 weeks and 6 weeks after medication, and 4 weeks after drug withdrawal
the changes of central corneal thickness
The central corneal thickness was assessed by anterior segment OCT at baseline and all the follow-up visits. The alterations in central corneal thickness were evaluated.
Measured: Baseline, 1 week, 2 weeks, 4 weeks and 6 weeks after medication, and 4 weeks after drug withdrawal
the changes of conjunctival hyperemia score
The conjunctival hyperemia score was assessed by severity from 0 (no signs of conjunctival hyperemia) to 3 (serious conjunctival hyperemia) by the clinician at baseline and all the follow-up visits.The changes of conjunctival hyperemia score were evaluated.
Measured: Baseline, 1 week, 2 weeks, 4 weeks and 6 weeks after medication, and 4 weeks after drug withdrawal
the changes of corneal fluorescein staining score
The corneal fluorescein staining score was assessed by NEI grading system by the clinician at baseline and all the follow-up visits.The NEI grading system divides the cornea into 5 zones: central, superior, temporal, nasal, and inferior. For each zone, the amount of corneal fluorescein staining is graded on a scale of 0 to 3: 0=normal or negative slit-lamp findings; 1=milder superfacial stippling; 2=moderate or punctate staining, including superfacial abrasion of the cornea; and 3=severe abrasion or corneal erosion, deep corneal abrasion, or recurrent erosion. The alterations in corneal fluorescein staining score were evaluated.
Measured: Baseline, 1 week, 2 weeks, 4 weeks and 6 weeks after medication, and 4 weeks after drug withdrawal
the changes of corneal sensation
The corneal sensation was assessed through Cochet-Bonnet aesthesiometer by the clinician at baseline and 4 weeks after drug withdrawal. The corneal sensation was assessed at five points on the cornea, including the central, superior, temporal, nasal, and inferior points.
Measured: Baseline and 4 weeks after drug withdrawal
the morphological changes of corneal subepithelial nerve
In vivo confocal laser scanning microscopy was performed by the clinician at baseline and 4 weeks after drug withdrawal. The density and length of the corneal subepithelial nerve were analysed.
Measured: Baseline and 4 weeks after drug withdrawal
the changes of ocular tolerability score
Ocular tolerability score (including ocular tolerability, burning sensation, pain, itching and blurred vision) was assessed by severity from 0 (absent) to 3 (severe) by questionnaire.
Measured: 1 week, 2 weeks, 4 weeks and 6 weeks after medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start10 Aug 2021
- Primary completion9 Aug 2022 (estimated)
- Study completion9 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal NeovascularizationStudies of the same condition, open and under way.
- More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe 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
- Model description
- 4
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Yuan, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05011916
- Sponsor's protocol ID
- 2021KYPJ139
- Status last verified
- Aug 2021
- First submitted
- 7 Aug 2021
- Last updated
- 18 Aug 2021
- 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 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study on the Safety and Efficacy of KDR2-2 Suspension Eye Drops in the Treatment of Corneal Neovascularization
- ClinicalTrials.gov ID
- NCT05011916
- Acronym / sponsor ID
- 2021KYPJ139
- Conditions
- Corneal Neovascularization
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- 9 Aug 2022 (estimated)
- Study completion
- 9 Aug 2022 (estimated)
- First posted
- 18 Aug 2021 (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.
KDR2-2, as a tyrosine kinase inhibitor, has a strong inhibitory effect on VEGFR2 and a moderate inhibitory effect on PDGFR-β. It can be used for the treatment of corneal neovascularization. The main purpose of this study is to explore the efficacy and safety of KDR2-2 suspension eye drops in the treatment of corneal neovascularization. This study is a single-center, prospective, randomized controlled clinical study. A total of 60 patients with corneal neovascularization were enrolled in this study, and they were randomly divided into 4 groups, including the control group, the KDR2-2 low-concentration (4mg/ml) group, the medium-concentration (10mg/ml) group, and the high-concentration (20mg/ml) group, with 15 subjects in each group. The control group applied 0.1% fluorometholone eye drops, and the test groups applied KDR2-2 suspension eye drops with 0.1% fluorometholone eye drops. Patients applied KDR2-2 eye drops four times daily for 6 weeks and were followed up to 10 weeks. The follow-up time points were baseline, 1 week, 2 weeks, 4 weeks, 6 weeks after medication, and 4 weeks after drug withdrawal. Relevant ophthalmological examinations (including visual acuity, intraocular pressure, slit lamp microscopy, central corneal thickness measurement, corneal fluorescein staining assessment, corneal sensitivity measurement, corneal confocal microscope examination, and anterior segment and fundus photography) are performed at each time. And the ocular tolerability score and adverse events of each patient were recorded. By comparative analysis, the efficacy and safety of KDR2-2 eye drops in the treatment of corneal neovascularization were evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Patients in the control group received 0.1% fluorometholone eye drops (0.1% fluorometholone + 0.05% tacrolimus eye drops for patients after corneal transplantation). The patients applied 0.1% fluorometholone eye drops 4 times daily for 10 weeks. Patients were instructed to continue with their usual ophthalmic medication regimens, such as topical antibacterial and antiviral drugs. |
| Low-concentration group | Experimental | Drug: KDR2-2 suspension eye dropsPatients in the low-concentration group applied 4mg/ml KDR2-2 suspension eye drops 4 times daily for 6 weeks. The rest of the medication regimen is the same as the control group. |
| Medium-concentration group | Experimental | Drug: KDR2-2 suspension eye dropsPatients in the medium-concentration group applied 4mg/ml KDR2-2 suspension eye drops 4 times daily for 6 weeks. The rest of the medication regimen is the same as the control group. |
| High-concentration group | Experimental | Drug: KDR2-2 suspension eye dropsPatients in the High-concentration group applied 4mg/ml KDR2-2 suspension eye drops 4 times daily for 6 weeks. The rest of the medication regimen is the same as the control group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- voluntarily participate in the trial, sign the informed consent form, and follow up according to the time specified by the trial;
- 18~75 years old, without gender limit;
- Superficial or deep corneal progressive neovascularization induced by trauma, chemical burns, corneal transplantation and inflammation: the growth of corneal new vessels≥ 2 mm from the limbus within 1 week to 2 months.
Key exclusion criteria (12 listed)
- Obvious corneal epithelial defects (>1mm), or a history of persistent corneal epithelial defects in the past 3 months (>1mm, ≥14 days);
- Anti-VEGF drugs have been injected locally in the target eye within 3 months, or anti-VEGF drugs have been used systemically within 2 months;
- Recent eye surgery (except for keratoplasty) within 3 months, or planned eye surgery during the trial period;
- Systemic use of glucocorticoid drugs, or intraocular or periocular injection of glucocorticoid drugs within 1 month;
- Contact lenses use within the past 2 weeks (except bandage lenses);
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 |
|---|---|---|
| KDR2-2 suspension eye dropsAll patients were instructed to instill one drop four times per day in the study eye for 6 weeks. | Drug | High-concentration group, Low-concentration group, Medium-concentration group |
Primary outcome
the changes of the size and extent of corneal neovascularization
Time frame: Baseline, 1 week, 2 weeks, 4 weeks and 6 weeks after medication, and 4 weeks after drug withdrawal
The efficacy of KDR2-2 eye drops treatment on corneal neovascularization was evaluated by comparing corneal anterior segment photographs acquired at baseline with photographs acquired on the follow-up visits. Size and extent of CNV was investigated by four primary metrics: (1) neovascular area ratio, the ration of the area of the neovascularization to the area of the cornea, (2) vessel length (VL), the total length of the vessels projected into the cornea, (3) vessel caliber, the mean diameter of the corneal vessels, and (4) Corneal neovascularization progression/stabilization/regression rate
8 secondary outcomes
the changes of visual acuity
Time frame: Baseline, 1 week, 2 weeks, 4 weeks and 6 weeks after medication, and 4 weeks after drug withdrawal
the changes of intraocular pressure
Time frame: Baseline, 1 week, 2 weeks, 4 weeks and 6 weeks after medication, and 4 weeks after drug withdrawal
the changes of central corneal thickness
Time frame: Baseline, 1 week, 2 weeks, 4 weeks and 6 weeks after medication, and 4 weeks after drug withdrawal
the changes of conjunctival hyperemia score
Time frame: Baseline, 1 week, 2 weeks, 4 weeks and 6 weeks after medication, and 4 weeks after drug withdrawal
the changes of corneal fluorescein staining score
Time frame: Baseline, 1 week, 2 weeks, 4 weeks and 6 weeks after medication, and 4 weeks after drug withdrawal
the changes of corneal sensation
Time frame: Baseline and 4 weeks after drug withdrawal
the morphological changes of corneal subepithelial nerve
Time frame: Baseline and 4 weeks after drug withdrawal
the changes of ocular tolerability score
Time frame: 1 week, 2 weeks, 4 weeks and 6 weeks after medication
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
Related trials for Corneal Neovascularization
RecruitingPhase 2/3
Corneal Crosslinking for Treatment of Corneal Neovascularization
Corneal Neovascularization
Recruiting
Fine-needle Diathermy Combined With Subconjunctival Bevacizumab for Corneal Neovascularization
Corneal Neovascularisation
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. This study is not recruiting at the moment.
2 sites 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 KDR2-2 suspension eye drops in people with Corneal Neovascularization, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 2 sites 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 3 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qian Wang, PhD (18843014719, 419059130@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the changes of the size and extent of corneal neovascularization (time frame: Baseline, 1 week, 2 weeks, 4 weeks and 6 weeks after medication, and 4 weeks after drug withdrawal). 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 18 Aug 2021.