This clinical trial is designed to investigate differences in terms of efficacy (mean change in best corrected visual acuity obtained after 12 months of treatment) and safety, of 3 therapeutic estrategies for non-tractional macular edema in diabetic patients: a) laser alone; b) laser plus tiramcinolon; and c) laser plus bevacizumab.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
105
Grid laser therapy acts as the standard to refer to as it is the treatment which is currently accepted by EMDDNT.
Triamcinolone 4 mg followed by modified grid laser therapy after 3-4 weeks
Bevacizumab (1.25 mg initially, weeks 6 and 12) followed by modified grid laser therapy after3-4 weeks
Hospital Universitario Dr Negrín
Las Palmas de Gran Canaria, Spain
Best-Corrected Visual Acuity (BCVA)
To evaluate the effect on best-corrected visual acuity (BCVA) of intravitreal triamcinolone (Triesence ®) or bevacizumab (Avastin ®) in combination with grid laser therapy compared to grid laser therapy alone after 12 months of treatment, in diabetic patients with not tractional diffuse macular edema (NTDDEM)
Time frame: 12 months
To assess the safety of intravitreal Triesence (r)
Type of adverse events, severity and number of Participants with Adverse Events as a Measure of Safety and Tolerability.
Time frame: Baseline, 3m, 6m and 12 months
To measure average change in mean central macular thickness in each group.
To measure average change in mean central macular thickness (in microns) obtained by Optical Coherence Tomography (OCT) at each follow-up visits compared to the baseline visit in each of the three groups.
Time frame: Baseline and 3, 6 and 12 months after the treatment was initiated.
To assess the safety of intravitreal Avastin (r)
Type of adverse events, severity and number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Baseline, 3m, 6m and 12 months
To assess the safety of intravitreal grid photocoagulation
Type of adverse events, severity and number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Baseline, 3m, 6m and 12 months
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