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Not yet recruiting NCT07718503

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

No phase Interventional Retinal Vein Occlusion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Conbercept Ophthalmic Injection, Tongluo Huayu Formula, Laser Photocoagulation.
Who it may be relevant to
Registry conditions: Retinal Vein Occlusion. Basic parameters: 40 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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

  • Drug Conbercept Ophthalmic Injection
    Intravitreal injection of Conbercept will be administered once a month for 3 consecutive months.
  • Other Tongluo Huayu Formula
    The Tongluo Huayu Formula will be administered for 1 month.
  • Procedure Laser Photocoagulation
    Laser photocoagulation will be administered if large areas of retinal non-perfusion or fundus neovascularization occur.

Primary outcome measures

  • Central Macular Thickness（CMT） [Time frame: Baseline, and at 1, 2, 3, and 6 months after treatment.]
Secondary outcome measures (10)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou

Identifiers

NCT: NCT07718503 · IIT20260045C-R1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗