New eye drug PRO-169 takes on lucentis in major trial

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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). Exclusion Criteria: * Chronic renal disease with renal insufficiency that requires dialysis or transplant. * Individuals with conditions that may compromise their participation during the span of the study (unstable concomitant diseases, possible change of residence, etc) * Individuals with a poor glycemic control who have started insulin treatment within 4 months previous to the study. * Participation in another clinical study (at least 90 days must have elapsed between the finalization of his/her participation in a previous essay and randomization in the present study). * Known allergies to the treatment. * Poorly controlled blood pressure (average of 3 readings while sitting with ≥160 mmHg systolic or ≥100 mmHg diastolic in the selection visit. * Heart attack or other cardiovascular event (cerebral vascular disease, transitory ischemia, hospitalization for cardiac insufficiency) during the 4 months prior to the start of the study, or patients with active myocardial insufficiency. * Previous systemic treatment with VEGF-related medications within 4 months prior to the start of the study. * Women of child-bearing age who are pregnant, lactating of planning to get pregnant within the time span of the study. * Known allergy to anesthetic medications used during the procedures, intravitreal injection and photocoagulation. * Diagnosis of non-diabetic macular edema. * Ophthalmic conditions that interfere with the evaluation of BCVA (for example: foveal atrophy, pigmentary abnormalities, dense foveal exudates, etc) * Additional conditions to DM that may compromise the evaluation of the edema (for example: venous occlusions, uveitis or other inflammatory diseases, neovascular glaucoma, etc) * Lens opacities that according to the LOCS III classification system exceed one or more of the following: \> NO3C3, \> C2, \> P1. * Previous history of anti-VEGF treatment for diabetic macular edema or any treatment for diabetic macular edema within 4 months prior to the start of the study (corticosteroids, photocoagulation, etc) * Anticipation of the need of panphotocoagulation (for example: proliferative diabetic retinopathy or any other indication) during the period of the study or history of panphotocoagulation within the 4 months prior to the start of the study. * History of ocular surgery (cataract extraction, any intraocular surgery, aphakia, etc) within 4 months prior to the start of the study, or planned to occur within the time span of the study. * Intraocular pressure \> 21 mmHg, measured through Goldmann tonometry during the selection visit. * Presence of macular ischemia or important loss of perifoveal capilaries (avascular foveal zone greater than 350 μm) demonstrated through fluorescein angiography during the selection visit. * Evidence of macular traction and hyaloid thickening in OCT scan. * History of YAG capsulotomy within 2 months prior to the randomization. * Evidence of external ocular infections or any important disease of the ocular surface. * History of vitrectomy.