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

NCT ID: NCT05699759

Last Updated: 2024-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-04
• Study Completion Date: 2024-06-20

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients with Diabetic Macular Edema

Patients with Diabetic Macular Edema

Group Type: EXPERIMENTAL

K8

Intervention Type: 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).

Interventions

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).

Intervention Type: DRUG

Other Intervention Names

SOM-401

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Inflammasome Therapeutics

UNKNOWN

Sponsor Role: collaborator

Michelle Abou-Jaoude

OTHER

Sponsor Role: lead

Responsible Party

Michelle Abou-Jaoude

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Michelle Abou-Jaoude, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

University of Kentucky

Lexington, Kentucky, United States

Countries

United States

Other Identifiers

79071

Identifier Type: -

Identifier Source: org_study_id