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CompletedNCT06234514JQMMT+RAUpdated Aug 22, 2025

Manage Macular Cystoid Edema With Retinal Vein Obstruction Using Traditional Chinese Medicine and Ranibizumab

A Phase 4 interventional study of Jueling Mingmu decoction and intravitreal injections of 0.5mg ranibizumab in Macular Cystoid Edema, sponsored by Dongyang People's Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-22.

Sponsored by Dongyang People's Hospital · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Jan 2023, registered Jan 2024).
Phase
Phase 4
Study type
Interventional
Enrollment
111
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Compared to the sole intravitreal injection of ranibizumab, the combined use of traditional Chinese medicine with intravitreal ranibizumab aims to determine if it is more effective in alleviating macular cystoid edema secondary to retinal branch vein occlusion, leading to improved visual prognosis and potentially reducing the frequency of intravitreal drug injections.

02

Conditions studied

  • Macular Cystoid Edema

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Keywords

  • Traditional Chinese Medicine
  • Ranibizumab
  • Retinal Vein Obstruction
03

In context

Macular Edema

841 studies on the registry are indexed under Macular Edema; 56 are open to participants now.

This study's enrollment of 111 is above the median of 50 across 619 interventional studies indexed under Macular Edema.

Browse Macular Edema studies →

Lead sponsor

Dongyang People's Hospital is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
111 participants (actual)

Study arms

  • Experimental
    Combination Therapy Group

    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 decoction · Drug: intravitreal injections of 0.5mg ranibizumab

  • Active comparator
    Intravitreal Ranibizumab Group

    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

  • DrugJueling Mingmu decoction

    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.

  • Drugintravitreal injections of 0.5mg ranibizumab

    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

06

What researchers measure

Primary outcomes

  1. Mean number of injections

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

    Time frame: 48 weeks

Secondary outcomes

  1. Change in BCVA

    We will assess the participants' best-corrected distance visual acuity by ETDRS charts before and after the treatment at weeks 48.

    Time frame: 48 weeks

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

    The participants' eyes will be fully dilated; the examiner will take the macular fovea as the center and perform a multi-directional, 6 mm-long, radial linear scan of the most prominent macular lesions and take linear scans in the same direction after the treatment. CRT is defined as the distance between internal limiting membrane and external limiting membrane, excluding the fluid under the retinal pigment epithelium (RPE).

    Time frame: 48 weeks

07

Study locations

1 site
  • Dongyang People's Hospital
    Dongyang, Zhejiang 322100, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06234514
Lead sponsor
Dongyang People's Hospital
Responsible party
Zhou Hangshuai (doctor, Dongyang People's Hospital) — Principal investigator
First posted
Jan 31, 2024
Start date
Jan 1, 2023
Primary completion
May 31, 2025
Completion
May 31, 2025
Last update
Aug 22, 2025

Study contacts

Guangjin Zhao
study director · Dongyang People's Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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