Clinical Study to Evaluate PRO-169 for Diabetic Macular Edema

Prior treatment

• 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).
• 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.
• 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.
• History of YAG capsulotomy within 2 months prior to the randomization.

Other illness

• Chronic renal disease with renal insufficiency that requires dialysis or transplant.
• Known allergies to the treatment.
• Known allergy to anesthetic medications used during the procedures, intravitreal injection and photocoagulation.
• 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)
• Evidence of external ocular infections or any important disease of the ocular surface.
• History of vitrectomy.

Age

• Women of child-bearing age who are pregnant, lactating of planning to get pregnant within the time span of the study.

Other

• Poorly controlled blood pressure (average of 3 readings while sitting with ≥160 mmHg systolic or ≥100 mmHg diastolic in the selection visit.
• Diagnosis of non-diabetic macular edema.
• Lens opacities that according to the LOCS III classification system exceed one or more of the following: \> NO3C3, \> C2, \> P1.
• 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.

• 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 \<9.5% 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).