The aim of this study is to evaluate the visual outcome and prognostic factors after intraocular injections of Ranibizumab or combination of Ranibizumab And Dexamethasone under pro re nata treatment regimen for Diabetic Macular Edema patients.
The aim of this study is to evaluate the clinical outcome after intraocular injections of Ranibizumab or combination of Ranibizumab and Dexamethasone under pro re nata treatment regimen for the patients with Diabetic Macular Edema patients. Mean change of logarithm of the minimal angle of resolution (logMAR) visual acuity (VA), central foveal thickness (CFT), contrast sensitivity (CS) as well as predictive factors including best-corrected visual acuity (BCVA), vision related questionnaires and various other ocular parameters will be assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
Pro re nata patients with macula edema due to diabetes will receive Ranibizumab. Group A will continue to receive Ranibizumab depending on their clinical status of macular edema
Group B will initially receive intravitreal Dexamethasone and Ranibizumab and then depending on their clinical status of macular edema, Ranibizumab will be injected.
He Eye Specialist Hospital
Shenyang, Liaoning, China
Mean change in monocular BCVA in the treatment eye
Monocular BCVA in the treatment eye is assessed by using ETDRS visual acuity charts at 4 meters at baseline (pre-treatment) and 1 week, 1month, 2 months, 3 months, and 6 months after treatment.
Time frame: Baseline, 1 week, 1month, 2 months, 3 months, and 6 months.
Mean change in binocular BCVA
Binocular BCVA is assessed by using ETDRS visual acuity charts at 4 meters at baseline (pre-treatment) and 1 week, 1month, 2 months, 3 months, and 6 months after treatment.
Time frame: Baseline, 1 week, 1month, 2 months, 3 months, and 6 months.
Mean change in central subfield retinal thickness
Mean change in central subfield retinal thickness in the study eye, as determined by spectral domain optical coherence tomography (OCT), from baseline to 6 months.
Time frame: Baseline, 1 week, 1month, 2 months, 3 months, and 6 months.
Change in Humphrey 10-2 visual field in the treatment eye
Mean deviation (MD) of the Humphrey 10-2 visual field is assessed by a Humphrey 10-2 visual field test at baseline, 1 week, 1month, 2 months, 3 months, and 6 months.
Time frame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
People meeting driving standards
Percentage (%) of people meeting driving standards is assessed by an Esterman binocular visual field test at baseline and and 6 months.
Time frame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Mean change in NEI VFQ25
Scores from NEI VFQ25 questionnaire will be assessed and compared at baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
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Time frame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Mean change in EQ-5D 5L
Scores from EQ-5D 5L questionnaire will be assessed and compared at baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Time frame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Mean change in VisQoL scores
Scores from VisQoL questionnaire will be assessed and compared at baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Time frame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Mean change in wavefront aberrations
Mean deviation (MD) of wavefront aberrations is assessed by Nidek OPD Scan III test at baseline, 1 week, 1month, 2 months, 3 months, and 6 months.
Time frame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Mean change in ocular surface and tear-film
Mean deviation (MD) of ocular surface and tear-film parameters is assessed by Oculus Keratographer test at baseline, 1 week, 1month, 2 months, 3 months, and 6 months.
Time frame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Mean change in vessel density
Mean deviation (MD) of vessel density is assessed by Spectralis OCT2, Heidelberg-Engineering test at baseline, 1 week, 1month, 2 months, 3 months, and 6 months.
Time frame: Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months.
Side effects
Side effects are measured by a review of the participant's medical and ophthalmic history.
Time frame: 1 week, 1 month, 2 months, 3 months, and 6 months.
Use of additional treatments (including laser)
Use of additional treatments (including laser) is assessed by the treating ophthalmologist
Time frame: 1 week, 1 month, 2 months, 3 months, and 6 months.