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Completed

NCT Number: NCT06234514

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

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.

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Key information

Conditions

Macular Cystoid Edema Eye Diseases Macular Degeneration Macular Edema Retinal Degeneration Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dongyang People's Hospital

Dongyang, Zhejiang, 322100, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Jueling Mingmu decoction

Drug

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.

intravitreal injections of 0.5mg ranibizumab

Drug

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.

Other names: 0.5mg ranibizumab

Primary outcomes

  1. Mean number of injections

    Time frame: 48 weeks

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

Secondary outcomes

  1. Change in BCVA

    Time frame: 48 weeks

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

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

    Time frame: 48 weeks

    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).

Sponsors and collaborators

Lead sponsor

Dongyang People's Hospital

Other

Registry information

Official study title

Traditional Chinese Medicine and Ranibizumab in the Treatment of Macular Cystoid Edema Associated With Retinal Vein Obstruction.

Acronym: JQMMT+RA

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 31, 2024
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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