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Purpose

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).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 18 years or older - BCVA 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-OCT - Ability and willingness to comply with the treatment and follow-up procedures - Ability to understand and sign the informed consent form - Intraocular pressure of ≤ 21 on 2 or less IOP lowering medications

Exclusion 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 system - Any ocular surgery in the study eye within 12 weeks of screening - Any history of vitrectomy in the study eye - Aphakia in the study eye - Presence of severe foveal ischemia, defined as foveal avascular zone (FAZ) of >1.5 mm2 on OCT-Angiography - Prior intraocular or periocular treatment for DME - Macular laser for the treatment of diabetic macular edema within 12 weeks of screening - Any change in systemic steroidal therapy within 3 months of screening - Retinal or choroidal neovascularization due to ocular conditions other than diabetic retinopathy - History or presence of viral disease of the cornea or conjunctiva - History 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 pole - Participation in another clinical trial within 12 weeks before the screening visit or during the study - Expectation 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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Patients with Diabetic Macular Edema 		Patients with Diabetic Macular Edema
  • Drug: K8
    Subjects will have the treatment administered intravitreally (one eye only) using an injector system on a 24-gauge needle to deliver a cylindrical, 3 mm long, drug eluting pellet containing 300 µg of K8. Participants will be followed for 168 days (24 weeks).
    Other names:
    • SOM-401

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40506

More Details

NCT ID
NCT05699759
Status
Recruiting
Sponsor
Michelle Abou-Jaoude

Study Contact

Sara Kuhl
859-562-3570
sara.kuhl@uky.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.