refractory diabetes macular edema
Conditions
Interventions
observation group:None
control group:None
Sponsors
Qilu Hospital of Shandong University Dezhou Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Over 18 years old; 2. Having symptoms such as vision loss, visual distortion or visual field obstruction; 3. Diagnosed with type 2 diabetes by an endocrinologist, and determined by an ophthalmologist specializing in fundus diseases based on OCT, FFA and specialized examination results as diabetic retinopathy (DR); 4. Meeting the criteria for refractory diabetic macular edema (DME): After receiving anti-VEGF drug treatment for 3 consecutive months (once a month), the re-examination in the 4th month shows that compared to the baseline, the central foveal retinal thickness (CMT) has decreased by less than 10%, or CMT remains at 300 µm or above, or visual acuity has decreased by at least two lines (i.e., 10 letters); 5.Good blood sugar control, with fasting blood glucose not exceeding 8.0 mmol/L and glycated hemoglobin (HbA1c) not exceeding 7.0%; 6. Able to complete at least 9 months of follow-up observation.
Exclusion criteria
Exclusion criteria: 1. Ocular factors: Unclear refractive media, inability to assess fundus lesions; Recent ocular surgery history (within 1 month for external eye surgery, within 3 months for cataract surgery, within 3 months for vitreous hemorrhage, within 6 months for vitrectomy); Active ocular infections; Other ocular lesions, such as glaucoma, retinal detachment, retinal artery occlusion, macular hole, etc; 2. Systemic factors: Currently using drugs that may be toxic to the retina or optic nerve; with severe cardiovascular and cerebrovascular diseases, liver diseases, hematopoietic system diseases, and immune system diseases; with severe primary diseases and mental disorders that seriously threaten life; Pregnant or lactating women; Participated in other clinical trials within 3 months before enrollment;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Macular fovea thickness,CMT; | — |
Secondary
| Measure | Time frame |
|---|---|
| Macular volume,TMV;Best corrected vision;Expression of various proteins in the aqueous humor; | — |
Countries
China
Contacts
Public ContactJing Wang
Qilu Hospital of Shandong University Dezhou Hospital
Outcome results
None listed