Manage Macular Cystoid Edema With Retinal Vein Obstruction Using Traditional Chinese Medicine and Ranibizumab (JQMMT+RA)

Dongyang People's Hospital

Status and phase: Enrolling; Phase 4

Conditions: Macular Cystoid Edema

Treatments: Drug: intravitreal injections of 0.5mg ranibizumab; Drug: Jueling Mingmu decoction

Study type: Interventional

Funder types: Other

Identifiers

NCT06234514

JQMMT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Combination Therapy Group

Experimental group

Description:

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.

Treatment:

Drug: Jueling Mingmu decoction

Drug: intravitreal injections of 0.5mg ranibizumab

Intravitreal Ranibizumab Group

Active Comparator group

Description:

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.

Treatment:

Drug: intravitreal injections of 0.5mg ranibizumab