Under an NDA, FDA permission was granted to pursue human studies of intravitreal erythropoietin in diabetic eyes. In a phase 1A study of 5 eyes with severe, chronic progressive diabetic macular edema with progressive vision loss in spite of prior multi-modal treatment (surgery, lasers and intraocular injections) Epo (5U /50 μL) was injected intravitreally every 6 weeks for three doses and followed for an additional 6 weeks with complete ocular examinations, fluorescein angiography (FA), spectral domain optical coherence tomography (SDOCT), and Omnifield acuity perimetry. All patients had subjectively improved vision in the treated eye with acuity improving >3 ETDRS lines in 3 eyes, two lines in one eye, and one line in one eye. Visual acuity improved to a larger extent than edema thickness improvement by SDOCT. Clearing of lipid exudates was observed but no improvement in subjective fluorescein leakage on FA. Improvement in vision occurred within 1 week after the first injection and was maintained.
Because of these results, FDA permission has been granted for a phase 1B dosing study in diabetic eyes with edema that is under process.