Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Jaeb Center for Health Research
With
National Institutes of Health (NIH)
National Eye Institute (NEI)
Juvenile Diabetes Research Foundation
Roche Pharma AG
The Leona M. and Harry B. Helmsley Charitable Trust
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age ≥18 years and \< 80 years.
Type 1 or type 2 diabetes.
At least one eye with the following:
* Mild to moderately severe NPDR (defined by ETDRS DR severity level 35 to 47), confirmed by central Reading Center grading of fundus photographs.
* Best-corrected E-ETDRS visual acuity letter score of ≥74 (approximate Snellen equivalent 20/32 or better). If best corrected letter score is 74-78, investigator must verify that vision loss is not due to the presence of CI-DME, cataract, or other condition that may affect visual acuity during the course of the study.
If only one eye is eligible, the non-study eye must have at least microaneurysms only (DR severity level 20)
Current CI-DME based on clinical exam or OCT central subfield thickness (CST)
* Zeiss Cirrus: CST ≥290 µm in women or ≥ 305 µm in men
* Heidelberg Spectralis: CST ≥305 µm in women or ≥320 µm in men
Any prior treatment for DME or DR, other than focal/grid laser. If the eye has a history of focal/grid laser, it must be at least 12 months prior.
History of intraocular anti-VEGF or corticosteroid treatment within the prior year for any indication
Decreased renal function, defined as requiring dialysis or central laboratory eGFR value \< 45 mL/min/1.73 m2
