Retinal vein occlusion macular edema
Conditions
Interventions
Control Group:Patients in the experimental group received the same Conbercept intravitreal injection regimen as the control group. they were administered the oral Chinese herbal formula Guishao Chaili
Experimental Group:Patients in the control group received intravitreal injections of Conbercept Ophthalmic Injection(Manufacturer: Chengdu Kanghong Biotech Co.Ltd
National Drug Approval No: S20130012). The initial injection was administered on the day of enrollment. Subsequent injections were administered on Day 31 and Day 61 resulting in a total of three injec
Sponsors
The Second Affiliated Hospital of Fujian University ofTraditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosis: Meets established Western medical diagnostic criteria for non-ischemic retinal vein occlusion with macular edema (RVO-ME) and Traditional Chinese Medicine (TCM) diagnostic criteria. 2. TCM Pattern: Meets specific criteria for the relevant TCM pattern diagnosis (syndrome differentiation). 3. Age: Aged between 40 and 70 years (inclusive). 4. Consent & Compliance: Provides written informed consent (patient and/or legally authorized representative) and demonstrates good expected compliance with the ability to complete all study procedures.1.
Exclusion criteria
Exclusion criteria: 1. Concurrent Trials or Therapies: Concurrent participation in other clinical trials or concomitant use of Traditional Chinese Medicine (TCM) formulations targeting RVO-ME or other therapies for this condition. 2. Ocular Comorbidities: Presence of glaucoma full-thickness macular hole central serous chorioretinopathy (CSC) diabetic retinopathy (DR) retinitis pigmentosa (RP) retinal detachment or any other significant retinal pathology known to affect visual acuity. 3. Media Opacity: Significant opacity of the ocular media sufficient to interfere with reliable ocular assessments (e.g. fundus examination imaging). 4. Systemic Comorbidities: History of severe cardiocerebrovascular diseases or moderate to severe hepatic or renal dysfunction. 5. Pregnancy/Lactation: Currently pregnant or lactating. 6. Psychiatric Disorders: Active psychiatric disorders requiring treatment. 7. Allergy/Hypersensitivity: Known hypersensitivity or contraindication to any medication used in the study procedures or treatments. 8. Uncontrolled Comorbidities: Inadequately controlled hypertension or diabetes mellitus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Central Macular Thickness;best corrected visual acuity; | — |
Secondary
| Measure | Time frame |
|---|---|
| TCM syndrome differentiation efficacy scores;NEI-VFQ-25;subfoveal choroidal thickness;clinical efficacy;subfoveal choriocapillaris flow area; | — |
Countries
China
Contacts
Public ContactYanhong Hu
The Second Affiliated Hospital of Fujian University ofTraditional Chinese Medicine
Outcome results
None listed