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Clinical trial

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

ID
Name
JQMMT
Description
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.
Trial arms
Trial start
2023-01-01
Estimated PCD
2024-12-31
Trial end
2024-12-31
Status
Recruiting
Phase
Early phase I
Treatment
Jueling 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.
Arms:
Combination Therapy Group
intravitreal 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.
Arms:
Combination Therapy Group, Intravitreal Ranibizumab Group
Other names:
0.5mg ranibizumab
Size
100
Primary endpoint
Mean number of injections
48 weeks
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2024-01-31

1 organization

2 products

1 indication

Organization
Dongyang People's Hospital
Product
Jueling Mingmu decoction
Indication
Macular Edema
Product
Ranibizumab