Current On-going Clinical Trials.
NIH/NEI Sponsored Diabetic Retinopathy Clinical Research Network - DRCR.net - Dedicated to multicenter clinical research of diabetic retinopathy, macular edema and associated disorders
Protocol T - Comparative Effectiveness Study of Aflibercept, Bevacizumab and Ranibizumab for:
• Type 1 or type 2 diabetes.
• Central-involved DME in study eye (OCT CSF ≥250 µm on Zeiss Stratus or the equivalent on spectral domain OCT based on gender specific cutoffs) within eight days of randomization.
• Visual acuity letter score in study eye ≤ 78 and ≥24 (approximate Snellen equivalent 20/32 to 20/320) within eight days of randomization.
• No history of an anti-VEGF treatment for DME in the past 12 months in the study eye and no history of any other treatment for DME in the study eye at any time in the past four months (such as focal/grid macular photocoagulation, intravitreal or peribulbar corticosteroids).
• No history of major ocular surgery in the study eye within prior four months or anticipated within the next six months following randomization.
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Brief Inclusion Criteria:
1.Age >= 18 years
2.Diagnosis of diabetes mellitus (type 1 or type 2)
Meets all of the following ocular criteria in at least the one eye:
1.Best corrected E-ETDRS visual acuity letter score ≥ 79 (approximate Snellen equivalent 20/25 or better) at two consecutive visits within 1 to 28 days.
2.On clinical exam, definite retinal thickening due to DME involving the center of the macula.
3.Diabetic macular edema confirmed on OCT (equivalent to CSF thickness on OCT ≥250 microns on Zeiss Stratus or gender-specific spectral domain OCT equivalent) at two consecutive visits within 1 to 28 days.