Macular Cystoid Edema
Conditions
Keywords
Traditional Chinese Medicine, Ranibizumab, Retinal Vein Obstruction
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.
Interventions
DRUGJueling 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.
DRUGintravitreal 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.
Sponsors
Dongyang People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean number of injections | 48 weeks | We will calculate the mean number of intravitreal ranibizumab injections at week 48. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
China
Outcome results
None listed