Natural history of diabetic macular edema and factors predicting outcomes in sham-treated patients (MEAD study).
Graefes Arch Clin Exp Ophthalmol
; 257(12): 2639-2653, 2019 Dec.
Article
in En
| MEDLINE
| ID: mdl-31654188
ABSTRACT
PURPOSE:
To describe the natural history of diabetic macular edema (DME) with respect to best-corrected visual acuity (BCVA) and central retinal thickness (CRT) outcomes and to identify baseline patient characteristics and systemic factors associated with improvement or worsening of outcomes in sham-treated patients.METHODS:
The study population was sham-treated patients (n = 350) in the 3-year MEAD registration study of dexamethasone intravitreal implant for treatment of DME. Patients had center-involved DME and received sham intravitreal injections in the study eye at ≥ 6-month intervals. Potential prognostic factors for outcomes were evaluated using multiple linear regression analysis.RESULTS:
Visual and anatomic outcomes were poorer in patients who left the study early (n = 198) than in study completers (n = 152). Mean change in BCVA from baseline at the last visit with available data was + 0.9 letters; 37.5% of patients had no change in BCVA, 23.2% had gained > 10 letters, and 16.0% had lost > 10 letters. Older age and baseline diabetic retinopathy score > 6 were associated with worse BCVA outcomes; thicker baseline CRT and larger number of hypertension medications used were associated with larger reductions in CRT during the study.CONCLUSIONS:
BCVA and CRT outcomes were variable in this population of DME patients with generally good glycemic control. In DME patients without active treatment, older age and baseline diabetic retinopathy score > 6 were associated with less improvement in BCVA; thicker baseline CRT and a larger number of antihypertensive medications used predicted better improvement in CRT. TRIAL REGISTRATION The MEAD study trials are registered at ClinicalTrials.gov with the identifiers NCT00168337 and NCT00168389.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Dexamethasone
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Visual Acuity
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Macular Edema
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Tomography, Optical Coherence
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Diabetic Retinopathy
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Fovea Centralis
Type of study:
Diagnostic_studies
/
Etiology_studies
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Observational_studies
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Prognostic_studies
/
Risk_factors_studies
Limits:
Female
/
Humans
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Male
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Middle aged
Language:
En
Journal:
Graefes Arch Clin Exp Ophthalmol
Year:
2019
Type:
Article
Affiliation country:
South Korea