Manage Macular Cystoid Edema with Retinal Vein Obstruction Using Traditional Chinese Medicine and Ranibizumab
- Conditions
- Macular Cystoid Edema
- Interventions
- Drug: Jueling Mingmu decoctionDrug: intravitreal injections of 0.5mg ranibizumab
- Registration Number
- NCT06234514
- Lead Sponsor
- Dongyang People's Hospital
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Combination Therapy Group Jueling Mingmu decoction 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. Intravitreal Ranibizumab 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. Combination Therapy Group intravitreal injections of 0.5mg ranibizumab 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.
- Primary Outcome Measures
Name Time Method Mean number of injections 48 weeks We will calculate the mean number of intravitreal ranibizumab injections at week 48.
- Secondary Outcome Measures
Name Time Method Change in BCVA 48 weeks We will assess the participants' best-corrected distance visual acuity by ETDRS charts before and after the treatment at weeks 48.
The mean change of central retinal thickness (CRT). 48 weeks 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).
Trial Locations
- Locations (1)
Dongyang People's Hospital
🇨🇳Dongyang, Zhejiang, China