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

NCT07718503 · tracked via the Priya Life Science China tracker

Sponsor

First Affiliated Hospital of Zhejiang University

Phase

Not applicable

Started

2026-06

Last updated

2026-07-22

Condition(s) studied

Retinal Vein Occlusion

Investigational drug(s) / intervention(s)

Conbercept Ophthalmic InjectionTongluo Huayu FormulaLaser Photocoagulation

Conbercept Ophthalmic Injection: Intravitreal injection of Conbercept will be administered once a month for 3 consecutive months.

Tongluo Huayu Formula: The Tongluo Huayu Formula will be administered for 1 month.

Laser Photocoagulation: Laser photocoagulation will be administered if large areas of retinal non-perfusion or fundus neovascularization occur.

Study 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.

Eligibility

Sex

ALL

Min age

40 Years

Max age

70 Years

Healthy volunteers

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.

Primary outcome measure(s)

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).

Trial sites (1)

Facility	City	Region	Status
The First Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07718503 on ClinicalTrials.gov ↗ ← All trials in China