Retinal Vein OcclusionNCT07718503
A Study on the Combination of Tongluo Huayu Formula in Treating RVO of Phlegm-Stasis Intertwinement Type: Based on the Mechanism of Systemic Metabolic Regulation Mediated by Gut Microbiota
A study testing Conbercept Ophthalmic Injection, Tongluo Huayu Formula and Laser Photocoagulation in people with Retinal Vein Occlusion, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the synergistic efficacy and safety of the Tongluo Huayu Formula combined with conventional Western medical treatment for RVO, thereby providing high-quality evidence to support its subsequent clinical promotion and application. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Retinal Vein Occlusion
- What is being tested?
- Conbercept Ophthalmic Injection, Tongluo Huayu Formula and Laser Photocoagulation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Jun 2026to 31 Dec 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who meet the aforementioned Western diagnostic criteria and TCM syndrome differentiation criteria for RVO, and are complicated with macular edema.
- Patients who fully understand the study and voluntarily sign the informed consent form.
Who cannot join
- Patients currently participating in other clinical trials or receiving concomitant use of similar traditional Chinese medicines or other therapies.
- Patients with other fundus retinal diseases, such as neovascular glaucoma or iris neovascularization.
- Patients with severe systemic diseases, such as rheumatism or systemic lupus erythematosus.
- Women who are pregnant or breastfeeding (lactating).
- Patients with severe cardiovascular or cerebrovascular diseases, or those with severely impaired hepatic or renal function.
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
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Wei Zhou, 18101092595, 15575924800@163.com
About this study
Official title: A Study on the Combination of Tongluo Huayu Formula in Treating Retinal Vein Occlusion of Phlegm-Stasis Intertwinement Type: Based on the Mechanism of Systemic Metabolic Regulation Mediated by Gut Microbiota
The goal of this clinical trial is to evaluate the synergistic efficacy and safety of the Tongluo Huayu Formula combined with conventional Western medical treatment for RVO, thereby providing high-quality evidence to support its subsequent clinical promotion and application.
The control group will receive conventional Western medical therapy, including laser photocoagulation and intravitreal Conbercept injection. Specifically, Conbercept will be injected intravitreally once a month for 3 consecutive months. If large areas of retinal non-perfusion or fundus neovascularization occur during the study period, laser photocoagulation will be administered based on the patient's condition. The experimental group will receive the Tongluo Huayu Formula in addition to the standard therapy provided to the control group. The Tongluo Huayu Formula will be administered for 1 month. Relevant examinations and assessments for participants in both groups will be conducted at baseline (before treatment), and at 1, 2, 3, and 6 months after treatment.
- Conditions
- Retinal Vein Occlusion
- Being tested
- Conbercept Ophthalmic Injection, Tongluo Huayu Formula, Laser Photocoagulation
- Keywords
- Tongluo Huayu Formula, Conbercept, Traditional Chinese Medicine
- Medical subject headings
- Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conbercept Ophthalmic InjectionDrug
Intravitreal injection of Conbercept will be administered once a month for 3 consecutive months.
Tongluo Huayu FormulaOther
The Tongluo Huayu Formula will be administered for 1 month.
Laser PhotocoagulationProcedure or surgery
Laser photocoagulation will be administered if large areas of retinal non-perfusion or fundus neovascularization occur.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Combined TCM and Western Medicine Receives: Drug: Conbercept Ophthalmic Injection; Other: Tongluo Huayu Formula; Procedure: Laser Photocoagulation |
| Control Group | Active comparator | Conventional Western Medicine Only Receives: Drug: Conbercept Ophthalmic Injection; Procedure: Laser Photocoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Macular Thickness（CMT）
Central Macular Thickness (CMT) measured by Optical Coherence Tomography Angiography (OCTA) in micrometers (μm).
Measured: Baseline, and at 1, 2, 3, and 6 months after treatment.
Secondary outcomes (10)
Best Corrected Visual Acuity(BCVA)
Best Corrected Visual Acuity (BCVA) assessed using the standard logarithmic visual acuity chart, reported as LogMAR score.
Measured: Baseline, and at 1, 2, 3, and 6 months after treatment
Superficial retinal capillary plexus vessel density(VD-SCP)
Superficial retinal capillary plexus vessel density (VD-SCP) measured by OCTA, reported as percentage (%) of vessel area.
Measured: Baseline, and at 1, 2, 3, and 6 months after treatment
Deep retinal capillary plexus vessel density (VD-DCP)
Deep retinal capillary plexus vessel density (VD-DCP) measured by OCTA, reported as percentage (%) of vessel area.
Measured: Baseline, and at 1, 2, 3, and 6 months after treatment
Foveal Avascular Zone area(FAZ)
Foveal Avascular Zone area(FAZ) measured by Optical Coherence Tomography Angiography (OCTA) in Square millimeters (mm²).
Measured: Baseline, and at 1, 2, 3, and 6 months after treatment
Ganglion Cell Layer Thickness(GCL)
Ganglion Cell Layer Thickness(GCL) measured by Optical Coherence Tomography Angiography (OCTA) in micrometers (μm).
Measured: Baseline, and at 1, 2, 3, and 6 months after treatment
Ganglion Cell-Inner Plexiform Layer Thickness
Ganglion Cell-Inner Plexiform Layer Thickness measured by Optical Coherence Tomography Angiography (OCTA) in micrometers (μm).
Measured: Baseline, and at 1, 2, 3, and 6 months after treatment
Carotid plaque
Presence of carotid plaque (yes/no) measured by B-mode ultrasound.
Measured: Baseline, and at 3 and 6 months after treatment
Retinal circulation time
Retinal circulation time measured by fundus fluorescein angiography (FFA) in Seconds (s)- typically arm-to-retina circulation time.
Measured: Baseline, and at 3 and 6 months after treatment
Retrobulbar blood flow
Retrobulbar blood flow parameters measured by color Doppler ultrasound include peak systolic velocity (PSV, cm/s) and end-diastolic velocity (EDV, cm/s) and resistive index (RI).
Measured: Baseline, and at 3 and 6 months after treatment
Gut microbiota
Gut microbiota measured by 16S rRNA sequencing include Alpha diversity (e.g., Shannon index) or Relative abundance of specific taxa (%).
Measured: Baseline, and at 1, 2, 3, and 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study startJun 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal Vein OcclusionStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to either the control group or the experimental group and treated simultaneously.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang Provincial Tongde Hospital, The Fourth Affiliated Hospital of Zhejiang University School of Medicine
- Responsible party
- Sponsor
- Investigators
- Hongguang Cui, Principal investigator, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07718503
- Sponsor's protocol ID
- IIT20260045C-R1
- Status last verified
- May 2026
- First submitted
- 2 Jun 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared with external researchers. The raw clinical data collected in this trial only serves for internal statistical analysis and scientific research of the research team, and there is no relevant data sharing plan at present.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Combination of Tongluo Huayu Formula in Treating Retinal Vein Occlusion of Phlegm-Stasis Intertwinement Type: Based on the Mechanism of Systemic Metabolic Regulation Mediated by Gut Microbiota
- ClinicalTrials.gov ID
- NCT07718503
- Acronym / sponsor ID
- IIT20260045C-R1
- Conditions
- Retinal Vein Occlusion
- Keywords
- Tongluo Huayu Formula, Conbercept, Traditional Chinese Medicine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Zhejiang Provincial Tongde Hospital, The Fourth Affiliated Hospital of Zhejiang University School of Medicine
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 22 Jul 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 synergistic efficacy and safety of the Tongluo Huayu Formula combined with conventional Western medical treatment for RVO, thereby providing high-quality evidence to support its subsequent clinical promotion and application.
The control group will receive conventional Western medical therapy, including laser photocoagulation and intravitreal Conbercept injection. Specifically, Conbercept will be injected intravitreally once a month for 3 consecutive months. If large areas of retinal non-perfusion or fundus neovascularization occur during the study period, laser photocoagulation will be administered based on the patient's condition. The experimental group will receive the Tongluo Huayu Formula in addition to the standard therapy provided to the control group. The Tongluo Huayu Formula will be administered for 1 month. Relevant examinations and assessments for participants in both groups will be conducted at baseline (before treatment), and at 1, 2, 3, and 6 months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to either the control group or the experimental group and treated simultaneously.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: Conbercept Ophthalmic Injection, Other: Tongluo Huayu Formula, Procedure: Laser PhotocoagulationCombined TCM and Western Medicine |
| Control Group | Active comparator | Drug: Conbercept Ophthalmic Injection, Procedure: Laser PhotocoagulationConventional Western Medicine Only |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who meet the aforementioned Western diagnostic criteria and TCM syndrome differentiation criteria for RVO, and are complicated with macular edema.
- Patients who fully understand the study and voluntarily sign the informed consent form.
Key exclusion criteria (5 listed)
- Patients currently participating in other clinical trials or receiving concomitant use of similar traditional Chinese medicines or other therapies.
- Patients with other fundus retinal diseases, such as neovascular glaucoma or iris neovascularization.
- Patients with severe systemic diseases, such as rheumatism or systemic lupus erythematosus.
- Women who are pregnant or breastfeeding (lactating).
- Patients with severe cardiovascular or cerebrovascular diseases, or those with severely impaired hepatic or renal function.
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 |
|---|---|---|
| Conbercept Ophthalmic InjectionIntravitreal injection of Conbercept will be administered once a month for 3 consecutive months. | Drug | Control Group, Experimental Group |
| Tongluo Huayu FormulaThe Tongluo Huayu Formula will be administered for 1 month. | Other | Experimental Group |
| Laser PhotocoagulationLaser photocoagulation will be administered if large areas of retinal non-perfusion or fundus neovascularization occur. | Procedure or surgery | Control Group, Experimental Group |
Primary outcome
Central Macular Thickness（CMT）
Time frame: Baseline, and at 1, 2, 3, and 6 months after treatment.
Central Macular Thickness (CMT) measured by Optical Coherence Tomography Angiography (OCTA) in micrometers (μm).
10 secondary outcomes
Best Corrected Visual Acuity(BCVA)
Time frame: Baseline, and at 1, 2, 3, and 6 months after treatment
Superficial retinal capillary plexus vessel density(VD-SCP)
Time frame: Baseline, and at 1, 2, 3, and 6 months after treatment
Deep retinal capillary plexus vessel density (VD-DCP)
Time frame: Baseline, and at 1, 2, 3, and 6 months after treatment
Foveal Avascular Zone area(FAZ)
Time frame: Baseline, and at 1, 2, 3, and 6 months after treatment
Ganglion Cell Layer Thickness(GCL)
Time frame: Baseline, and at 1, 2, 3, and 6 months after treatment
Ganglion Cell-Inner Plexiform Layer Thickness
Time frame: Baseline, and at 1, 2, 3, and 6 months after treatment
Carotid plaque
Time frame: Baseline, and at 3 and 6 months after treatment
Retinal circulation time
Time frame: Baseline, and at 3 and 6 months after treatment
Retrobulbar blood flow
Time frame: Baseline, and at 3 and 6 months after treatment
Gut microbiota
Time frame: Baseline, and at 1, 2, 3, and 6 months after treatment
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 22 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared with external researchers. The raw clinical data collected in this trial only serves for internal statistical analysis and scientific research of the research team, and there is no relevant data sharing plan at present.
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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.
Hongguang Cui principal investigator
Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conbercept Ophthalmic Injection, Tongluo Huayu Formula and Laser Photocoagulation in people with Retinal Vein Occlusion, run by First Affiliated Hospital of Zhejiang 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 2 inclusion and 5 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: opening soon, as of the sponsor's last update on 22 Jul 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?
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 Wei Zhou (18101092595, 15575924800@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central Macular Thickness（CMT） (time frame: Baseline, and at 1, 2, 3, and 6 months after treatment.). 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 22 Jul 2026.