Phase III Non-inferiority Clinical Study to Evaluate the Efficacy and Safety of Intravitreous PRO-169 Compared to Ranibizumab for Diabetic Macular Edema
Phase III clinical study to evaluate the efficacy, expressed as improvement in visual acuity in patients suffering diabetic macular edema after one year of treatment with PRO-169, compared to treatment with Lucentis® (ranibizumab).
• Age ≥ 18 years
• Diagnosis of Diabetes Mellitus (type 1 or 2) evidenced by: use of insulin or use of oral hypoglycemic medications or diagnosis for DM according to OMS or ADA criteria.
• Is capable of rendering informed consent.
• HbA1c \<8.5% in selection visit.
• All men and women capable of reproduction may agree to use a barrier birth control method during the study and 3 months after the last intravitreal injection applied.
• Only one eye may be randomized per participating individual, in case both are eligible, the investigator may choose either eye according his/her criteria.
• BVCA according to ETDRS between \<78 (20/32 or worse) and \>24 (20/320 or better) within 8 days prior to the randomization.
• Clinically evident diabetic macular edema, with central macular thickening.
• Diabetic macular edema demonstrated in OCT scan (macular central thickness \> 300 μm for men and \> 290 μm for women) within 8 days prior to the randomization.
• Presenting characteristics that allow an adequate fundus examination (transparent means, adequate pupil dilation, etc).