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| Name | Class |
|---|---|
| Ningbo Eye Hospital | OTHER |
| Jiaxing Hospital of T.C.M | UNKNOWN |
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The goal of this clinical trial is to learn if the efficacy of dexamethasone implant combined with anti-VEGF superior to anti-VEGF monotherapy in the treatment of DME in Chinese patients. The main questions it aims to answer are:
Researchers will compare the combination therapy to the monotherapy to see if dexamethasone implant combined with anti-VEGF will leads to better results.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The combination of intravitreal anti-VEGF and dexamethasone implants injections. | Experimental | The patients will receive the combination of intravitreal anti-VEGF and dexamethasone implants injections. |
|
| Anti-VEGF injections monotherapy | No Intervention | The patients will receive intravitreal anti-VEGF injections. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The combination of intravitreal anti-VEGF and dexamethasone implants injections. | Combination Product | Early combination of intravitreal dexamethasone implant and anti-VEGF injection for the treatment of DME. |
| Measure | Description | Time Frame |
|---|---|---|
| Average change in best corrected visual acuity (BCVA) of each group from baseline to the end of month 6. | BCVA was measured using the log Mar visual acuity chart or the ETDRS visual acuity chart. | 6 month. |
| Measure | Description | Time Frame |
|---|---|---|
| Average change in best corrected visual acuity (BCVA) of each group from baseline to month 3, 12. | BCVA was measured using the log Mar visual acuity chart or the ETDRS visual acuity chart. | 3 month and 12 month |
| Average change in central retinal thickness (CRT) of each group from baseline to month 3, 6,12. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhiqing Chen, M.D. | Eye Center, The Second Affiliated Hospital, School of Medicine, Zhejiang University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye Center, The Second Affiliated Hospital, School of Medicine, Zhejiang University | Hangzhou | Zhejiang | 310000 | China |
demographic data, diagnostic results, treatment data, lab test results, follow-up data Etc.
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Central retinal thickness (CRT) is a measurement of the macula from the internal limiting membrane to the RPE and can be quantified by OCT scans |
| 3, 6 and 12 month |
| The proportion of eyes with a 5-letter /10-letter improvement from baseline of BCVA at month 6 and 12. | BCVA was measured using the log Mar visual acuity chart or the ETDRS visual acuity chart. | 6 month and 12 month |