Retinal Vein Occlusion
Conditions
Keywords
Tongluo Huayu Formula, Conbercept, Traditional Chinese Medicine
Brief 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. 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.
Interventions
Intravitreal injection of Conbercept will be administered once a month for 3 consecutive months.
OTHERTongluo Huayu Formula
The Tongluo Huayu Formula will be administered for 1 month.
PROCEDURELaser Photocoagulation
Laser photocoagulation will be administered if large areas of retinal non-perfusion or fundus neovascularization occur.
Sponsors
First Affiliated Hospital of Zhejiang University
Zhejiang Provincial Tongde Hospital
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants are randomly assigned to either the control group or the experimental group and treated simultaneously.
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Central Macular Thickness（CMT） | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best Corrected Visual Acuity(BCVA) | Baseline, and at 1, 2, 3, and 6 months after treatment | Best Corrected Visual Acuity (BCVA) assessed using the standard logarithmic visual acuity chart, reported as LogMAR score. |
| Superficial retinal capillary plexus vessel density(VD-SCP) | Baseline, and at 1, 2, 3, and 6 months after treatment | Superficial retinal capillary plexus vessel density (VD-SCP) measured by OCTA, reported as percentage (%) of vessel area. |
| Deep retinal capillary plexus vessel density (VD-DCP) | Baseline, and at 1, 2, 3, and 6 months after treatment | Deep retinal capillary plexus vessel density (VD-DCP) measured by OCTA, reported as percentage (%) of vessel area. |
| Foveal Avascular Zone area(FAZ) | Baseline, and at 1, 2, 3, and 6 months after treatment | Foveal Avascular Zone area(FAZ) measured by Optical Coherence Tomography Angiography (OCTA) in Square millimeters (mm²). |
| Ganglion Cell Layer Thickness(GCL) | Baseline, and at 1, 2, 3, and 6 months after treatment | Ganglion Cell Layer Thickness(GCL) measured by Optical Coherence Tomography Angiography (OCTA) in micrometers (μm). |
| Ganglion Cell-Inner Plexiform Layer Thickness | Baseline, and at 1, 2, 3, and 6 months after treatment | Ganglion Cell-Inner Plexiform Layer Thickness measured by Optical Coherence Tomography Angiography (OCTA) in micrometers (μm). |
| Carotid plaque | Baseline, and at 3 and 6 months after treatment | Presence of carotid plaque (yes/no) measured by B-mode ultrasound. |
| Retinal circulation time | Baseline, and at 3 and 6 months after treatment | Retinal circulation time measured by fundus fluorescein angiography (FFA) in Seconds (s)- typically arm-to-retina circulation time. |
| Retrobulbar blood flow | Baseline, and at 3 and 6 months after treatment | 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). |
| Gut microbiota | Baseline, and at 1, 2, 3, and 6 months after treatment | Gut microbiota measured by 16S rRNA sequencing include Alpha diversity (e.g., Shannon index) or Relative abundance of specific taxa (%). |
Countries
China
Contacts
CONTACTWei Zhou
PRINCIPAL_INVESTIGATORHongguang Cui
Zhejiang University
Outcome results
None listed