Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Aerpio Therapeutics
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Adults between 18 to 80 years of age, inclusive
Diagnosis of diabetes mellitus (type 1 or type 2)
Decrease in vision determined to be primarily the result of DME in the study eye
Definite Retinal thickening due to diffuse DME involving the center of the macula in the study eye
Mean central subfield thickness of at least 325 µm by OCT in the study eye
Early Treatment Diabetic Retinopathy Study (ETDRS) letter score BCVA ≤ 70 (20/40) in the study eye
You may not be if
Hemoglobin A1C (HbA1C) ≥ 11.5%
History of any of the following in the study eye (however, the following are not exclusionary in the fellow eye):
1. Panretinal scatter photocoagulation (PRP) or focal laser within 12 weeks prior to Screening
2. Prior pars plana vitrectomy within 12 weeks prior to Screening
3. Any ocular surgery within 12 weeks prior to Screening
4. YAG capsulotomy within 7 days prior to Screening
5. Prior intravitreal, subtenon, or periocular steroid therapy within 3 months prior to Screening or prior treatment with intravitreal anti-VEGF treatment within 1 month of Screening
Clareo Health | Safety and Pilot Efficacy of AKB-9778 in Subjects With Diabetic Macular Edema
