NCT06234514

Brief Summary

The objective of this study was to investigate the efficacy and safety of traditional Chinese medicine (Jueling Mingmu Decoction) combined with ranibizumab in the treatment of macular edema with retinal vein obstructive.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2023

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 31, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

August 22, 2025

Status Verified

August 1, 2025

Enrollment Period

2.4 years

First QC Date

January 21, 2024

Last Update Submit

August 18, 2025

Conditions

Macular Cystoid Edema

Keywords

Traditional Chinese MedicineRanibizumabRetinal Vein Obstruction

Outcome Measures

Primary Outcomes (1)

  • Mean number of injections

    We will calculate the mean number of intravitreal ranibizumab injections at week 48.

    48 weeks

Secondary Outcomes (2)

  • Change in BCVA

    48 weeks

  • The mean change of central retinal thickness (CRT).

    48 weeks

Study Arms (2)

Combination Therapy Group

EXPERIMENTAL

During the initial month, the patient consumed Jueling Mingmu decoction daily for one month. Patients received monthly intravitreal injections of 0.5mg ranibizumab for the initial three months, followed by additional injections in the subsequent nine months for those who met eligibility criteria.

Drug: Jueling Mingmu decoctionDrug: intravitreal injections of 0.5mg ranibizumab

Intravitreal Ranibizumab Group

ACTIVE COMPARATOR

Patients received monthly intravitreal injections of 0.5mg ranibizumab for the initial three months, followed by additional injections in the subsequent nine months for those who met eligibility criteria.

Drug: intravitreal injections of 0.5mg ranibizumab

Interventions

Jueling Mingmu decoctionDRUG

Jueling Mingmu decoction comprises stone cassia, grass cassia, Leonurus, chrysanthemum, red peony, Schizonepeta, poria, plantago, salvia miltiorrhiza, rice bud, licorice. It is designed to clear liver heat, promote diuresis, activate blood circulation, strengthen the stomach, and harmonize spleen functions.

Combination Therapy Group
intravitreal injections of 0.5mg ranibizumabDRUG

Patients received monthly intravitreal injections of 0.5mg ranibizumab for the initial three months, followed by additional injections in the subsequent nine months for those who met eligibility criteria.

Also known as: 0.5mg ranibizumab
Combination Therapy GroupIntravitreal Ranibizumab Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Foveal center-involved macular edema (ME) lasting less than 9 months
  • Central Macular Thickness (CMT) greater than or equal to 250 μm
  • Best-Corrected Visual Acuity (BCVA) of 24-73 letters (20/40 to 20/320) in the study eye
  • Initial diagnosis with no prior treatments, such as laser therapy or intravitreal injections

You may not qualify if:

  • Presence of any additional macular pathology, such as age-related macular degeneration (AMD) or diabetic retinopathy (DR) affecting the macula
  • Concurrent serious conditions, such as cardiovascular diseases, liver, or kidney diseases
  • Concerns or doubts regarding treatment
  • Known allergies to the ingredients of the medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dongyang People's Hospital

Dongyang, Zhejiang, 322100, China

Location

MeSH Terms

Conditions

Macular Edema

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Guangjin Zhao

    Dongyang People's Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

January 21, 2024

First Posted

January 31, 2024

Study Start

January 1, 2023

Primary Completion

May 31, 2025

Study Completion

May 31, 2025

Last Updated

August 22, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)