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

Michelle Abou-Jaoude

Status and phase

Completed

Phase 1

Conditions

Diabetic Macular Edema

Treatments

Drug: K8

Study type

Interventional

Funder types

Other

Identifiers

NCT05699759

79071

Details and patient eligibility

About

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).

Enrollment

1 patient

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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