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

NCT05699759 | Completed Phase 1 FDA Drug

• 1 other identifier: 79071
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Diabetic Macular Edema

Keywords

diabetes; kamuvudine; K8; SOM-401

Outcome Measures

Primary Outcomes (3)

• Mean change in central subfield thickness

  Central subfield thickness (CST) measured on spectral domain-optical coherence tomography (SD-OCT)

  At week 4 (change as measured from baseline)

• Mean change in best-corrected visual acuity (BCVA)

  best-corrected visual acuity as defined by the number of letters read on the scale set by the ETDRS (Early Treatment of Diabetic Retinopathy Study). (More letters read equates to better visual acuity)

  At week 4 (change as measured from baseline)

• Adverse Events

  Frequency of participants experiencing ocular or systemic adverse events.

  Within the study period (of 24 weeks)

Secondary Outcomes (11)

• Resolution of macular edema

  24 weeks (at 2, 4, 8, 12, 16, and 24 weeks)

• Clinically significant change in visual acuity

  24 weeks (at 2, 4, 8, 12, 16, and 24 weeks)

• Change in score on the ETDRS Multi-Step Scale of Diabetic Retinopathy

  24 weeks

• Visual acuity

  24 weeks (at 2, 4, 8, 12, 16, and 24 weeks)

• Change in retinal thickening

  24 weeks (at 2, 4, 8, 12, 16, and 24 weeks)

Study Arms (1)

Patients with Diabetic Macular Edema

EXPERIMENTAL

Patients with Diabetic Macular Edema

Drug: K8

Interventions

K8 DRUG

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).

Also known as: SOM-401

Patients with Diabetic Macular Edema

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Michelle Abou-Jaoude: lead
• Inflammasome Therapeutics: collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Potassium, Dietary

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Potassium Compounds; Inorganic Chemicals

Study Officials

• Michelle Abou-Jaoude, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 23, 2022
• First Posted: January 26, 2023
• Study Start: January 4, 2024
• Primary Completion: June 20, 2024
• Study Completion: June 20, 2024
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)