The Condition of Fundus NeovascularizationNCT06300918
A Clinical Trial to Evaluate the Time Point of Anti-VEGF Pretreatment of PDR Based on Intraoperative FFA
A study testing Time in people with The Condition of Fundus Neovascularization, run by Jie Li at 1 site in China.
Trial summary
The goal of this prospective randomized controlled study is to compare the therapeutic effect of injecting anti-VEGF drugs before surgery for patients with proliferative diabetic retinopathy at different time points. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- The Condition of Fundus Neovascularization
- What is being tested?
- Time
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 8 Mar 2024to 31 Aug 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PDR is diagnosed in people 18 years of age or older with type 1 or type 2 diabetes，
- Hemoglobin A1c (HbA1c) ≤10%
- Persistent vitreous hemorrhage for more than one month or recurrent vitreous hemorrhage (within six months)
- Did not undergo retintis photocoagulation (PRP)
- Vitreous hemorrhage disease course within six months
Who cannot join
- Patients who have had previous vitreoretinal surgery
- Intravitreal drug injection within 3 months
- Eye diseases other than PDR that may hinder vision improvement, such as optic atrophy or macular hole
- Thromboembolic events (including cerebrovascular or myocardial infarction) or clotting system disorders or receiving anticoagulation or antiplatelet therapy
- B-ultrasound or indirect fundus microscopy showing retina detachment (pull or hole origin)
- Vitrectomy, FFA contraindicated patients, patients with severe abnormality of cardiopulmonary, liver and kidney function
Trial locations and contacts
1 site in 1 country.
China1 site
Sichuan Academy of Medical Science Sichuan Provincial Hosptial
Chengdu, Sichuan, 610014
About this study
Official title: A Randomized Controlled Clinical Trial to Evaluate the Time Point of Anti-VEGF Pretreatment of PDR Based on Intraoperative FFA
The goal of this prospective randomized controlled study is to compare the therapeutic effect of injecting anti-VEGF drugs before surgery for patients with proliferative diabetic retinopathy at different time points. At present, studies have confirmed that anti-VEGF drugs are effective in inhibiting fundus neovascularization in proliferative diabetic retinopathy. The main question it aims to answer is which time point is better to injecting anti-VEGF drugs before surgery for patients with proliferative diabetic retinopathy.
Participants will be randomly divided into three groups. And time points of injecting anti-VEGF drugs before surgery for each group will be 3 days, 7 days, 14 days. And we have a new technology that can have fluorescein fundus angiography during operation, so it can reflect the condition of fundus neovascularization immediately and precisely. In that case, we can compare the Inhibitory effect of anti-VEGF drugs on fundus neovascularization at different time points.
- Being tested
- Time
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TimeOther
Time point of injecting anti-VEGF drugs
| Study group | Role | What they receive |
|---|---|---|
| 3-Day Conbercept-to-Vitrectomy Interval | Experimental | Participants received a single intravitreal injection of conbercept (0.5 mg/0.05 mL) 3 days before pars plana vitrectomy. Receives: Other: Time |
| 7-Day Conbercept-to-Vitrectomy Interval | Experimental | Participants received a single intravitreal injection of conbercept (0.5 mg/0.05 mL) 7 days before pars plana vitrectomy. Receives: Other: Time |
| 14-Day Conbercept-to-Vitrectomy Interval | Experimental | Participants received a single intravitreal injection of conbercept (0.5 mg/0.05 mL) 14 days before pars plana vitrectomy. Receives: Other: Time |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Active Retinal Neovascularization Tufts Assessed by Intraoperative Fluorescein Angiography
Number of active retinal neovascularization tufts identified on intraoperative fluorescein angiography images.
Measured: Intraoperatively, 1 to 3 minutes after fluorescein injection
Size of Active Retinal Neovascularization Assessed by Intraoperative Fluorescein Angiography
Neovascularization size was quantified by measuring the maximal linear diameter and normalizing it to the vertical optic disc diameter, expressed in papillary diameters (PD).
Measured: Intraoperatively, 1 to 3 minutes after fluorescein injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start8 Mar 2024
- Primary completion28 Feb 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Condition of Fundus NeovascularizationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jie Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jie Li, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06300918
- Sponsor's protocol ID
- 2024-KY76
- Status last verified
- Aug 2026
- First submitted
- 22 Feb 2024
- Last updated
- 12 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 2030, via https://pan.baidu.com
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial to Evaluate the Time Point of Anti-VEGF Pretreatment of PDR Based on Intraoperative FFA
- ClinicalTrials.gov ID
- NCT06300918
- Acronym / sponsor ID
- 2024-KY76
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Jie LiUniversity, hospital or other
- Study start
- 8 Mar 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 8 Mar 2024 (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 prospective randomized controlled study is to compare the therapeutic effect of injecting anti-VEGF drugs before surgery for patients with proliferative diabetic retinopathy at different time points. At present, studies have confirmed that anti-VEGF drugs are effective in inhibiting fundus neovascularization in proliferative diabetic retinopathy. The main question it aims to answer is which time point is better to injecting anti-VEGF drugs before surgery for patients with proliferative diabetic retinopathy.
Participants will be randomly divided into three groups. And time points of injecting anti-VEGF drugs before surgery for each group will be 3 days, 7 days, 14 days. And we have a new technology that can have fluorescein fundus angiography during operation, so it can reflect the condition of fundus neovascularization immediately and precisely. In that case, we can compare the Inhibitory effect of anti-VEGF drugs on fundus neovascularization at different time points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3-Day Conbercept-to-Vitrectomy Interval | Experimental | Other: TimeParticipants received a single intravitreal injection of conbercept (0.5 mg/0.05 mL) 3 days before pars plana vitrectomy. |
| 7-Day Conbercept-to-Vitrectomy Interval | Experimental | Other: TimeParticipants received a single intravitreal injection of conbercept (0.5 mg/0.05 mL) 7 days before pars plana vitrectomy. |
| 14-Day Conbercept-to-Vitrectomy Interval | Experimental | Other: TimeParticipants received a single intravitreal injection of conbercept (0.5 mg/0.05 mL) 14 days before pars plana vitrectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- PDR is diagnosed in people 18 years of age or older with type 1 or type 2 diabetes，
- Hemoglobin A1c (HbA1c) ≤10%
- Persistent vitreous hemorrhage for more than one month or recurrent vitreous hemorrhage (within six months)
- Did not undergo retintis photocoagulation (PRP)
- Vitreous hemorrhage disease course within six months
Key exclusion criteria (6 listed)
- Patients who have had previous vitreoretinal surgery
- Intravitreal drug injection within 3 months
- Eye diseases other than PDR that may hinder vision improvement, such as optic atrophy or macular hole
- Thromboembolic events (including cerebrovascular or myocardial infarction) or clotting system disorders or receiving anticoagulation or antiplatelet therapy
- B-ultrasound or indirect fundus microscopy showing retina detachment (pull or hole origin)
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 |
|---|---|---|
| TimeTime point of injecting anti-VEGF drugs | Other | 14-Day Conbercept-to-Vitrectomy Interval, 3-Day Conbercept-to-Vitrectomy Interval, 7-Day Conbercept-to-Vitrectomy Interval |
Primary outcome
Number of Active Retinal Neovascularization Tufts Assessed by Intraoperative Fluorescein Angiography
Time frame: Intraoperatively, 1 to 3 minutes after fluorescein injection
Number of active retinal neovascularization tufts identified on intraoperative fluorescein angiography images.
Size of Active Retinal Neovascularization Assessed by Intraoperative Fluorescein Angiography
Time frame: Intraoperatively, 1 to 3 minutes after fluorescein injection
Neovascularization size was quantified by measuring the maximal linear diameter and normalizing it to the vertical optic disc diameter, expressed in papillary diameters (PD).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: Yes. 2030, via https://pan.baidu.com
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time in people with The Condition of Fundus Neovascularization, run by Jie Li 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 6 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: finished, as of the sponsor's last update on 12 Aug 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Active Retinal Neovascularization Tufts Assessed by Intraoperative Fluorescein Angiography (time frame: Intraoperatively, 1 to 3 minutes after fluorescein injection). The study lists 2 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 12 Aug 2026.