Clinical Study to Evaluate PRO-169 for Diabetic Macular Edema (PRO-169)
Diabetic Macular Edema
About this trial
This is an interventional treatment trial for Diabetic Macular Edema
Eligibility Criteria
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.
Sites / Locations
- Fundación Oftalmológica Nacional
- SalaUno Salud, S.A.P.I. de C.V.Recruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
PRO-169
Lucentis ®
Bevacizumab 1.25 mg / 0.05mL for intravitreal injection. All patients in this arm will be exposed to one monthly injection for the first four months. During the rest of the study, during the monthly visits, it will be decided if injections are to be continued or postponed. The maximum amount of intravitreal injections to be administered are 12.
Ranibizumab 0.5 mg / 0.05mL for intravitreal injection. All patients in this arm will be exposed to one monthly injection for the first four months. During the rest of the study, during the monthly visits, it will be decided if injections are to be continued or postponed. The maximum amount of intravitreal injections to be administered are 12.