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: 1. Whether combination therapy improves the best corrected visual acuity at 6 months and 12 months? 2. Does combination therapy improve retinal anatomy better than monotherapy at each time point? 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: 1. be randomly assigned to one of two groups with equal probability to receive the combination of intravitreal anti-VEGF and dexamethasone implant injections or intravitreal anti-VEGF injections. 2. During the first 3 months, patients in both groups will receive monthly injections of anti-VEGF. In the double protocol group, the first dexamethasone implant injection will be administered simultaneously with the first loading dose of anti-VEGF injections. Between 4 and 12 months, patients will receive intravitreal anti-VEGF injections as needed/pro-re-nata (PRN). 3. Patients will have regular follow-up. Routine examination includes Central retinal thickness (CRT), intraocular pressure (IOP), slit lamp examination, best corrected visual acuity (BCVA) and OCT.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
70
Early combination of intravitreal dexamethasone implant and anti-VEGF injection for the treatment of DME.
Eye Center, The Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
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.
Time frame: 6 month.
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.
Time frame: 3 month and 12 month
Average change in central retinal thickness (CRT) of each group from baseline to month 3, 6,12.
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
Time frame: 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.
Time frame: 6 month and 12 month
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