Neovascular GlaucomaPhase 1KDR-NVGNCT04844619
KDR2-2 Suspension Eyedrop in the Treatment of Neovascular Glaucoma (KDR-NVG) Trial
A Phase 1 study testing 4mg/ml KDR2-2 suspension eyedrop and 16mg/ml KDR2-2 suspension eyedrop in people with Neovascular Glaucoma and Neovascularization, run by Sun Yat-sen University at 1 site in China.
Trial summary
The clinical trial is aimed to evaluate the anti-neovascular effect of KDR2-2 suspension eyedrop in the treatment of neovascular glaucoma. Fourty subjects would receive either 0.96 or 3.84 mg/per day/eye, in a QID fashion, ×7 days (those without complications can continue to 28 days). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neovascular Glaucoma, Neovascularization
- What is being tested?
- 4mg/ml KDR2-2 suspension eyedrop and 16mg/ml KDR2-2 suspension eyedrop
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 19 Apr 2021to 31 Dec 2024
- Phase
- Phase 1
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75;
- The best-corrected visual acuity (BCVA) of the included eyes was <0.01 (Snellen chart);
- The BCVA of the contralateral eye of the included subjects was >0.1;
- Patients with clinically diagnosed neovascular glaucoma; The diagnostic criteria for neovascularization glaucoma were as follows: Intraocular pressure > 21mmHg measured by Goldmann applanation tonometer; Neovascularization is seen in the iris or anterior chamber angle, with or without corneal edema;
- Compliance with follow up for more than 28 days and written informed consent obtained;
Who cannot join
- Intravitreal injection of anti-VEGF drugs within 3 month before enrollment;
- Participation in other clinical trials within 1 month;
- Suffering from other ocular diseases that affect ocular examinations (e.g. keratopathy, uveitis, intraocular infection, etc.);
- Those who plan to receive ocular surgery during the follow-up period;
- Premenopausal women without birth control;
- Having other systemic diseases such as severe liver and kidney function damage, cardiovascular disorders, respiratory disorders, etc.) that may affect the anti-neovascular effect of KDR2-2 or more likely to develop adverse events ;
- Systemic infections under treatment;
- Any study in which the physician believes that the patient's condition will interfere with the clinical trial (e.g., the patient is prone to stress, mood disorders, depression, etc.);
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Effectiveness of KDR2-2 Suspension Eyedrop on Neovascular Regression in the Treatment of Neovascular Glaucoma: an Exploratory Clinical Trial
The clinical trial is aimed to evaluate the anti-neovascular effect of KDR2-2 suspension eyedrop in the treatment of neovascular glaucoma. Fourty subjects would receive either 0.96 or 3.84 mg/per day/eye, in a QID fashion, ×7 days (those without complications can continue to 28 days). The anti-neovascular effect of KDR2-2 on iris neovascularization would be evaluated at day 1, day 7, day 14, day 28 after KDR2-2 usage.
Read the detailed description
Neovascular glaucoma (NVG) has a high blinding rate and poor prognosis. Anti-glaucoma surgery is the main stake of saving visual function and relieving pain, but the proliferation of iris neovascularization (NVI) makes it difficult to treat NVG. Normally, the patients need an intravitreal injection of anti-vascular endothelial growth factor (anti-VEGF) agents prior to glaucoma surgery to control the NVI proliferation.
KDR2-2, a novel small-molecule tyrosine kinase inhibitor targeting VEGF receptor 2 (VEGFR2), has demonstrated anti-neovascular effect without obvious side-effects or complications in animal studies and a Phase I clinical trial (NCT04620109). In this study, 40 patients with NVG will be included to evaluate the effectiveness of KDR2-2 suspension eyedrop on NVI in NVG eyes. The included subjects would receive either 0.96 or 3.84 mg/day/eye, in a QID fashion, ×7 days (those without complications can continue to 28 days).
This study aims to and propose a novel, non-invasive and more compliant method for the treatment of NVG.
- Conditions
- Neovascular Glaucoma, Neovascularization
- Being tested
- 4mg/ml KDR2-2 suspension eyedrop, 16mg/ml KDR2-2 suspension eyedrop
- Keywords
- Neovascular Glaucoma, Neovascularization, anti-VEGF, vascular endothelial growth factor
- Medical subject headings
- Glaucoma, Neovascular, Neovascularization, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4mg/ml KDR2-2 suspension eyedropDrug
Also called Low-dose KDR2-2
KDR2-2 is a synthetic anti-angiogenic chemical compound with highly effective inhibition on vascular endothelial growth factor receptor-2 (VEGFR2), and an additional, moderate inhibitory effect on platelet-derived growth factor receptor β (PDGFRβ).
KDR2-2 suspension eyedrop is developed for the treatment of iris neovascularization.
16mg/ml KDR2-2 suspension eyedropDrug
Also called High-dose KDR2-2
KDR2-2 is a synthetic anti-angiogenic chemical compound with highly effective inhibition on vascular endothelial growth factor receptor-2 (VEGFR2), and an additional, moderate inhibitory effect on platelet-derived growth factor receptor β (PDGFRβ).
KDR2-2 suspension eyedrop is developed for the treatment of iris neovascularization.
| Study group | Role | What they receive |
|---|---|---|
| KDR2-2 group | Experimental | The patients with NVG will receive 4.0 mg/ml or 16.0mg/ml KDR2-2 suspension eyedrop and the anti-neovascular effect of KDR2-2 would be evaluated during the follow-up visits. Receives: Drug: 4mg/ml KDR2-2 suspension eyedrop; Drug: 16mg/ml KDR2-2 suspension eyedrop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of iris neovascularization
Changes of the iris neovascularization using anterior photography or anterior optical coherence tomography angiography.
Measured: Day 0 and 7
Secondary outcomes (4)
Intraocular pressure
Measurement of intraocular pressure using non-contact tonometer or iCare tonometer
Measured: Day 0，7 and 28
Best-corrected visual acuity
Measurement of best-corrected visual acuity with Snellen LogMAR Chart
Measured: Day 0，7 and 28
Adverse events
Adverse events related with the anti-angiogenic effect of KDR2-2
Measured: Day 0，7 and 28
Changes of iris neovascularization
Changes of the iris neovascularization using anterior photography or anterior optical coherence tomography angiography.
Measured: Day 0，7 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start19 Apr 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular GlaucomaStudies of the same condition, open and under way.
- More trials run by 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiulan Zhang, Sun Yat-sen University
- Investigators
- Xiulan Zhang, MD, PhD, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04844619
- Sponsor's protocol ID
- 2021KYPJ080
- Acronym
- KDR-NVG
- Status last verified
- Dec 2024
- First submitted
- 13 Apr 2021
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effectiveness of KDR2-2 Suspension Eyedrop on Neovascular Regression in the Treatment of Neovascular Glaucoma: an Exploratory Clinical Trial
- ClinicalTrials.gov ID
- NCT04844619
- Acronym / sponsor ID
- KDR-NVG / 2021KYPJ080
- Conditions
- Neovascular Glaucoma, Neovascularization
- Keywords
- Neovascular Glaucoma, Neovascularization, anti-VEGF, vascular endothelial growth factor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 14 Apr 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.
The clinical trial is aimed to evaluate the anti-neovascular effect of KDR2-2 suspension eyedrop in the treatment of neovascular glaucoma. Fourty subjects would receive either 0.96 or 3.84 mg/per day/eye, in a QID fashion, ×7 days (those without complications can continue to 28 days). The anti-neovascular effect of KDR2-2 on iris neovascularization would be evaluated at day 1, day 7, day 14, day 28 after KDR2-2 usage.
Detailed description
Neovascular glaucoma (NVG) has a high blinding rate and poor prognosis. Anti-glaucoma surgery is the main stake of saving visual function and relieving pain, but the proliferation of iris neovascularization (NVI) makes it difficult to treat NVG. Normally, the patients need an intravitreal injection of anti-vascular endothelial growth factor (anti-VEGF) agents prior to glaucoma surgery to control the NVI proliferation.
KDR2-2, a novel small-molecule tyrosine kinase inhibitor targeting VEGF receptor 2 (VEGFR2), has demonstrated anti-neovascular effect without obvious side-effects or complications in animal studies and a Phase I clinical trial (NCT04620109). In this study, 40 patients with NVG will be included to evaluate the effectiveness of KDR2-2 suspension eyedrop on NVI in NVG eyes. The included subjects would receive either 0.96 or 3.84 mg/day/eye, in a QID fashion, ×7 days (those without complications can continue to 28 days).
This study aims to and propose a novel, non-invasive and more compliant method for the treatment of NVG.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KDR2-2 group | Experimental | Drug: 4mg/ml KDR2-2 suspension eyedrop, Drug: 16mg/ml KDR2-2 suspension eyedropThe patients with NVG will receive 4.0 mg/ml or 16.0mg/ml KDR2-2 suspension eyedrop and the anti-neovascular effect of KDR2-2 would be evaluated during the follow-up visits. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-75;
- The best-corrected visual acuity (BCVA) of the included eyes was <0.01 (Snellen chart);
- The BCVA of the contralateral eye of the included subjects was >0.1;
- Patients with clinically diagnosed neovascular glaucoma; The diagnostic criteria for neovascularization glaucoma were as follows: Intraocular pressure > 21mmHg measured by Goldmann applanation tonometer; Neovascularization is seen in the iris or anterior chamber angle, with or without corneal edema;
- Compliance with follow up for more than 28 days and written informed consent obtained;
Key exclusion criteria (8 listed)
- Intravitreal injection of anti-VEGF drugs within 3 month before enrollment;
- Participation in other clinical trials within 1 month;
- Suffering from other ocular diseases that affect ocular examinations (e.g. keratopathy, uveitis, intraocular infection, etc.);
- Those who plan to receive ocular surgery during the follow-up period;
- Premenopausal women without birth control;
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 |
|---|---|---|
| 4mg/ml KDR2-2 suspension eyedropAlso: Low-dose KDR2-2KDR2-2 is a synthetic anti-angiogenic chemical compound with highly effective inhibition on vascular endothelial growth factor receptor-2 (VEGFR2), and an additional, moderate inhibitory effect on platelet-derived growth factor receptor β (PDGFRβ). KDR2-2 suspension eyedrop is developed for the treatment of iris neovascularization. | Drug | KDR2-2 group |
| 16mg/ml KDR2-2 suspension eyedropAlso: High-dose KDR2-2KDR2-2 is a synthetic anti-angiogenic chemical compound with highly effective inhibition on vascular endothelial growth factor receptor-2 (VEGFR2), and an additional, moderate inhibitory effect on platelet-derived growth factor receptor β (PDGFRβ). KDR2-2 suspension eyedrop is developed for the treatment of iris neovascularization. | Drug | KDR2-2 group |
Primary outcome
Changes of iris neovascularization
Time frame: Day 0 and 7
Changes of the iris neovascularization using anterior photography or anterior optical coherence tomography angiography.
4 secondary outcomes
Intraocular pressure
Time frame: Day 0，7 and 28
Best-corrected visual acuity
Time frame: Day 0，7 and 28
Adverse events
Time frame: Day 0，7 and 28
Changes of iris neovascularization
Time frame: Day 0，7 and 28
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 Dec 2024.
- Individual participant dataSharing planned: No
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Intracameral Versus Intravitreal Bevacizumab Injection in NVG: RCT
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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.
Xiulan Zhang, MD, PhD principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 4mg/ml KDR2-2 suspension eyedrop and 16mg/ml KDR2-2 suspension eyedrop in people with Neovascular Glaucoma and Neovascularization, run by Sun Yat-sen University 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: under way, not looking for participants, as of the sponsor's last update on 11 Dec 2024. 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 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of iris neovascularization (time frame: Day 0 and 7). 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 Dec 2024.