Ensayos clínicos

Inclusion Criteria: 

• Signed informed consent must be obtained prior to participation in the study.
• Patients with type 1 or type 2 diabetes mellitus (DM) and Hemoglobin A1c (HbA1c) ≤ 12% at screening.
• Study eye: Visual impairment due to DME with:
• Best-corrected visual acuity (BCVA) score between 73 and 23 letters, inclusive, using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance of 4 meters
• DME involving the center of the macula, with Central Subfield Thickness (CSFT) ≥ 320 µm on Spectral Domain Optical Coherence Tomography (SD-OCT)

Exclusion Criteria:

• High-risk proliferative diabetic retinopathy (PDR) in the study eye.
• Concomitant conditions or ocular disorders in the study eye which confound interpretation of study results, compromise visual acuity or require medical or surgical intervention.
• Any active intraocular or periocular infection or active intraocular inflammation in the either eye.
• Uncontrolled glaucoma in the study eye.
• Presence of amblyopia, amaurosis or ocular disorders in the fellow eye with BCVA < 20/200.
• Use of anti-VEGF therapies, intraocular surgery or laser photocoagulation (macular or panretinal) in the study eye during the 3-month period prior to baseline.
• Use of intraocular or periocular corticosteroids in the study eye during the 6-month period prior to baseline, and use of fluocinolone acetonide intravitreal (IVT) implant (Iluvien) at any time prior to baseline - Prior investigational drugs in either eye, vitreoretinal surgery in the study eye at any time prior to baseline.