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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination Therapy Group | Experimental | 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. |
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| Intravitreal Ranibizumab Group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jueling Mingmu decoction | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean number of injections | We will calculate the mean number of intravitreal ranibizumab injections at week 48. | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in BCVA | We will assess the participants' best-corrected distance visual acuity by ETDRS charts before and after the treatment at weeks 48. | 48 weeks |
| The mean change of central retinal thickness (CRT). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guangjin Zhao | Dongyang People's Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongyang People's Hospital | Dongyang | Zhejiang | 322100 | China |
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| ID | Term |
|---|---|
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| intravitreal injections of 0.5mg ranibizumab | Drug | 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. |
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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).
| 48 weeks |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |