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 | Not Yet Recruiting

• 1 other identifier: IIT20260045C-R1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Retinal Vein Occlusion

Keywords

Tongluo Huayu Formula; Conbercept; Traditional Chinese Medicine

Outcome Measures

Primary Outcomes (1)

• Central Macular Thickness（CMT）

  Central Macular Thickness (CMT) measured by Optical Coherence Tomography Angiography (OCTA) in micrometers (μm).

  Baseline, and at 1, 2, 3, and 6 months after treatment.

Secondary Outcomes (10)

• Best Corrected Visual Acuity(BCVA)

  Baseline, and at 1, 2, 3, and 6 months after treatment

• Superficial retinal capillary plexus vessel density(VD-SCP)

  Baseline, and at 1, 2, 3, and 6 months after treatment

• Deep retinal capillary plexus vessel density (VD-DCP)

  Baseline, and at 1, 2, 3, and 6 months after treatment

• Foveal Avascular Zone area(FAZ)

  Baseline, and at 1, 2, 3, and 6 months after treatment

• Ganglion Cell Layer Thickness(GCL)

  Baseline, and at 1, 2, 3, and 6 months after treatment

Other Outcomes (8)

• Temperature

  Baseline, and at 3 and 6 months after treatment

• Heart rate

  Baseline, and at 3 and 6 months after treatment

• Blood pressure

  Baseline, and at 3 and 6 months after treatment

Study Arms (2)

Experimental Group

EXPERIMENTAL

Combined TCM and Western Medicine

Drug: Conbercept Ophthalmic Injection; Other: Tongluo Huayu Formula; Procedure: Laser Photocoagulation

Control Group

ACTIVE COMPARATOR

Conventional Western Medicine Only

Drug: Conbercept Ophthalmic Injection; Procedure: Laser Photocoagulation

Interventions

Tongluo Huayu Formula OTHER

The Tongluo Huayu Formula will be administered for 1 month.

Experimental Group

Laser Photocoagulation PROCEDURE

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

Control Group; Experimental Group

Conbercept Ophthalmic Injection DRUG

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

Control Group; Experimental Group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead
• Zhejiang Provincial Tongde Hospital: collaborator
• The Fourth Affiliated Hospital of Zhejiang University School of Medicine: collaborator

Study Sites (1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location

MeSH Terms

Conditions

Retinal Vein Occlusion

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Hongguang Cui

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Zhou

CONTACT

18101092595; 15575924800@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned to either the control group or the experimental group and treated simultaneously.

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: July 22, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)