A phase IIa, randomized, placebo-controlled, double-blind, parallel study to investigate the efficacy of EG-Mirotin subcutaneously administered in multiple doses on diabetic macular edema in diabetic retinopathy patients.

INTERVENTION: Product Name: EG‐Mirotin Pharmaceutical Form: Solution for injection Current Sponsor code: EGT022‐01 Other descriptive name: EG‐Mirotin Concentration unit: mg milligram(s) Concentration number: 1 or 2‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use CONDITION: diabetic retinopathy patients having early diabetic macular edema (DME) ; MedDRA version: 20.0 Level: PT Classification code 10012689 Term: Diabetic retinopathy System Organ Class: 10015919 ‐ Eye disorders Therapeutic area: Diseases [C] ‐ Eye Diseases [C11] PRIMARY OUTCOME: Main Objective: Primary objective : ; To evaluate the efficacy of EG‐Mirotin at doses 1mg and 2mg versus placebo on diabetic macular edema in diabetic retinopathy patients after 5 daily subcutaneous injections. Anatomical efficacy will be assessed by the measurement of central subfield retinal thickness (CSF Thickness) and retinal volume using Spectral Domain‐Optical Coherence Tomography (SD‐OCT). Primary end point(s): Primary endpoint ; Change of CSF‐thickness (measured by SD‐OCT) and retinal volume on study eye 4 weeks after 5 daily subcutaneous (SC) administrations of EG‐Mirotin at doses 1mg and 2mg. Secondary Objective: Secondary objective : ; To evaluate functional efficacy (visual acuity assessed by ETDRS charts); To evaluate reduction in vascular permeability using measurement of vascular leakage at the time of fluorescein angiography; To evaluate the safety and tolerability of multiple administered dose of EG‐Mirotin.; To evaluate the pharmacokinetic of EG‐Mirotin at doses 1mg and 2mg after 5 daily subcutaneous administrations. SECONDARY OUTCOME: Secondary end point(s): Secondary endpoints ; o Change of CSF‐thickness (measured by SD‐OCT) and retinal volume on study eye 2 weeks after 5 daily subcutaneous (SC) administrations of EG‐Mirotin at doses 1mg and 2mg.; o Assessment of best Corrected ETDRS visual acuity at 2, 4 and 8 weeks.; o Evaluation of vascular leakage (measured by fluorescein angiography) at 4 weeks; o Assessment of stereoscopic funduscopy (grading of diabetic retinopathy) at 2, 4 and 8 weeks; o Change of CSF‐thickness (measured by SD‐OCT) and retinal volume on fellow eye 2 weeks and 4 weeks after 5 daily subcutaneous (SC) administrations of EG‐Mirotin at doses 1mg and 2mg.; o Change of CSF‐thickness (measured by SD‐OCT) and retinal volume on study eye and contralateral 8 weeks after 5 daily subcutaneous (SC) administrations of EG‐Mirotin at doses 1mg and 2mg.; o Assessment of systemic and ocular tolerability and safety, ; o Pharmacokinetics assessment : Cmax, Tmax, AUC0‐24, AUCt, AUCinf, Kel, t1/2, %AUCextra, Vd, CL.; INCLUSION CRITERIA: Systemic : 1. Male/female patient, aged between 18 and 75 years inclusive. 2. Females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control (oral, transdermal, systemic or implant contraception birth control, intrauterine devices, diaphragm or condoms) for the duration of the trial and for 4 months after the last study drug administration. For sexually active male subjects with partners of childbearing potential: accepting to use effective methods of contraception during the study and for 16 weeks after the last drug intake. 3. Females of non‐childbearing potential: females must be either surgically sterilized or at least 1 year postmenopausal (amenorrhoea duration at least 12 months).To be eligible for entry into the study, females must have a negative pregnancy test at screening baseline. 4. Patient with type 2 diabetes mellitus with Hb1Ac (glycosylated haemoglobin) = 10%. 5. Body Mass