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

D

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

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

Trial contacts and locations

1

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Central trial contact

Hongyan Wu

Data sourced from clinicaltrials.gov

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