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

Dongyang People's Hospital111 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

111

Conditions

Macular Cystoid Edema

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.

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Dongyang People's Hospital

Dongyang, Zhejiang, China

Outcomes

Primary Outcomes

Mean number of injections

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

Time frame: 48 weeks

Secondary Outcomes

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

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

Data from ClinicalTrials.gov

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