Fenofibrate for Prevention of DR Worsening
- Conditions
- Diabetic Retinopathy
- Registration Number
- NCT04661358
- Lead Sponsor
- Jaeb Center for Health Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 560
Key Inclusion Criteria<br><br> - Age =18 years and < 80 years.<br><br> - Type 1 or type 2 diabetes.<br><br> - At least one eye with the following:<br><br> - Mild to moderately severe NPDR (defined by ETDRS DR severity level 35 to 47),<br> confirmed by central Reading Center grading of fundus photographs.<br><br> - Best-corrected E-ETDRS visual acuity letter score of =74 (approximate Snellen<br> equivalent 20/32 or better). If best corrected letter score is 74-78,<br> investigator must verify that vision loss is not due to the presence of CI-DME,<br> cataract, or other condition that may affect visual acuity during the course of<br> the study.<br><br> - If only one eye is eligible, the non-study eye must have at least microaneurysms<br> only (DR severity level 20)<br><br>Key Exclusion Criteria<br><br>Eye-level exclusion criteria (the eye is ineligible if any of the following is met):<br><br> - Current CI-DME based on clinical exam or OCT central subfield thickness (CST)<br><br> - Zeiss Cirrus: CST =290 µm in women or = 305 µm in men<br><br> - Heidelberg Spectralis: CST =305 µm in women or =320 µm in men<br><br> - Any prior treatment for DME or DR, other than focal/grid laser. If the eye has a<br> history of focal/grid laser, it must be at least 12 months prior.<br><br> - History of intraocular anti-VEGF or corticosteroid treatment within the prior year<br> for any indication<br><br>Participant-level exclusion criterion (the participant is ineligible if the following<br>criterion is met):<br><br>• Decreased renal function, defined as requiring dialysis or central laboratory eGFR<br>value < 45 mL/min/1.73 m2
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Worsening of diabetic retinopathy
- Secondary Outcome Measures
Name Time Method Intraocular procedure undertaken to treat diabetic retinopathy or diabetic macular edema including PRP, intraocular anti-VEGF, corticosteroid, focal/grid laser or vitrectomy;Development of CI-DME;Development of center-involved diabetic macular edema with vision loss;Visual acuity loss from any cause