Summary:
Clinical trial to evaluate the safety and efficacy of an ophthalmic solution in order to treat Diabetic Retinopathy
Criteria:Men or women ≥ 18 years of age with type 1 or 2 diabetes mellitus who have moderately severe to severe NPDR [DRSS levels 47 or 53], or mild PDR [DRSS level 61: NVE < 0.5 DA in
1 + quadrants], confirmed by the central reading center, in whom PRP and/or anti-VEGF intravitreal injection (IVT) can be safely deferred for at least 6 months per the Investigator. In respect to DRSS
level 61, participants with
≤ 1 neovascularization elsewhere (NVE) > 1 disk diameter (DD) from disc definitely present will be included. Any presence of FPD or FPE will be excluded (ETDRS Report 1991).
BCVA ETDRS letter score in the study eye of ≥ 69 letters (approximate Snellen equivalent of 20/40 or better)
Treatment-naïve (ie, no previous anti-VEGF or steroid treatment or PRP or laser within 1,000 μm diameter of the foveal center/treatment for macular edema or DR in the study eye)
Willing and able to return for all study visits and comply with study-related procedures
Able to adhere to the study dosing requirements
Understands and signs the written informed consent form (ICF)
Qualified Participants May Receive:
$100.00 compensation for COMPLETED VISITS