Safety and Effect of Intravitreal Injection of a Derivative of Nucleoside Reverse Transcriptase Inhibitor in Subjects With Diabetic Macular Edema

This study is designed to assess the safety and initial evidence of efficacy of the novel compound SOM-401 (K8), a derivative of a nucleoside reverse transcriptase inhibitor, in subjects with untreated, clinically significant, diabetic macular edema (DME).

Inclusion Criteria:18 years or olderBCVA of ≥ 24 and ≤ 73 letters (20/40 or worse but at least 20/320) by an ETDRS chart. BCVA of the non-study eye must be no worse than 20/400)Diagnosis of diabetes mellitus, type 1 or 2 with non-proliferative or non-high risk proliferative diabetic retinopathy.DME based on investigator's clinical evaluation and demonstrated on fundus photographs, fluorescein angiograms, and spectral domain-optical coherence tomography (SD-OCT)Mean foveal thickness of at least 300 µm by SD-OCTAbility and willingness to comply with the treatment and follow-up proceduresAbility to understand and sign the informed consent formIntraocular pressure of ≤ 21 on 2 or less IOP lowering medicationsExclusion Criteria:Pregnant patients, currently lactating patients, or females of childbearing potential (unless using reliable contraception such as double barrier, surgical sterilization, oral contraceptives, intrauterine device (IUD), etc.)Allergy or hypersensitivity (known or suspected) to fluorescein or any component of the investigational product or delivery systemAny ocular surgery in the study eye within 12 weeks of screeningAny history of vitrectomy in the study eyeAphakia in the study eyePresence of severe foveal ischemia, defined as foveal avascular zone (FAZ) of >1.5 mm2 on OCT-AngiographyPrior intraocular or periocular treatment for DMEMacular laser for the treatment of diabetic macular edema within 12 weeks of screeningAny change in systemic steroidal therapy within 3 months of screeningRetinal or choroidal neovascularization due to ocular conditions other than diabetic retinopathyHistory or presence of viral disease of the cornea or conjunctivaHistory or presence of any disease or condition that in the investigator's opinion would preclude study treatment or follow-up or that in the opinion of the investigator would render them as unlikely to benefit from study treatment.Any lens or corneal opacity which impairs visualization of the posterior poleParticipation in another clinical trial within 12 weeks before the screening visit or during the studyExpectation that subject will be moving away from the area of the clinical treatment center without the ability to return for visits within the study period