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

October 29, 2024 updated by: Michelle Abou-Jaoude

A Non-randomized, Open Label, Safety and Efficacy Study Evaluating a Single Dose of Kamuvudine-8 (K8) for the Treatment of Patients 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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40506
        • University Of Kentucky

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean change in central subfield thickness
Time Frame: At week 4 (change as measured from baseline)
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)
Time Frame: At week 4 (change as measured from baseline)
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
Time Frame: Within the study period (of 24 weeks)
Frequency of participants experiencing ocular or systemic adverse events.
Within the study period (of 24 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Resolution of macular edema
Time Frame: 24 weeks (at 2, 4, 8, 12, 16, and 24 weeks)
Frequency of participants experiencing resolution of macular edema
24 weeks (at 2, 4, 8, 12, 16, and 24 weeks)
Clinically significant change in visual acuity
Time Frame: 24 weeks (at 2, 4, 8, 12, 16, and 24 weeks)
Frequency of participants experiencing clinically significant change.
24 weeks (at 2, 4, 8, 12, 16, and 24 weeks)
Change in score on the ETDRS Multi-Step Scale of Diabetic Retinopathy
Time Frame: 24 weeks
The Early Treatment Diabetic Retinopathy Study (ETDRS DRSS) was developed to categorize the severity of diabetic retinopathy based on several fundus photographic characteristics. There are 13 levels in the original ETDRS scale, and a severity step or level increase is associated with an increased risk of retinopathy progression. The scale goes from 10 to 85, with higher scores being worse.
24 weeks
Visual acuity
Time Frame: 24 weeks (at 2, 4, 8, 12, 16, and 24 weeks)
The proportion of subjects who have an change from baseline of ETDRS letters read of ≥ 5 letters, ≥ 10 letters or ≥ 15 letters of visual acuity.
24 weeks (at 2, 4, 8, 12, 16, and 24 weeks)
Change in retinal thickening
Time Frame: 24 weeks (at 2, 4, 8, 12, 16, and 24 weeks)
Total area in disc diameters of retinal thickening of the lesion involving the foveal center, based on fundus imaging.
24 weeks (at 2, 4, 8, 12, 16, and 24 weeks)
Change in hard exudates
Time Frame: 24 weeks (at 2, 4, 8, 12, 16, and 24 weeks)
Total area in disc diameters of hard exudates in the lesion involving the macula, based on fundus imaging.
24 weeks (at 2, 4, 8, 12, 16, and 24 weeks)
Change in foveal avascular zone.
Time Frame: 24 weeks (at 2, 4, 8, 12, 16, and 24 weeks)
Foveal avascular zone size as determined using OCT-Angiography
24 weeks (at 2, 4, 8, 12, 16, and 24 weeks)
Proportion of subjects requiring rescue treatment
Time Frame: 24 weeks (at 2, 4, 8, 12, 16, and 24 weeks)
Proportion of subjects requiring rescue treatment
24 weeks (at 2, 4, 8, 12, 16, and 24 weeks)
Proportion of subjects requiring vitrectomy
Time Frame: 24 weeks (at 2, 4, 8, 12, 16, and 24 weeks)
Proportion of subjects requiring vitrectomy
24 weeks (at 2, 4, 8, 12, 16, and 24 weeks)
Mean change in central subfield thickness at other study timepoints
Time Frame: 24 weeks (at 2, 8, 12, 16, and 24 weeks)
Central subfield thickness (CST) measured on spectral domain-optical coherence tomography (SD-OCT)
24 weeks (at 2, 8, 12, 16, and 24 weeks)
Mean change in best-corrected visual acuity (BCVA) at other study timepoints
Time Frame: 24 weeks (at 2, 4, 8, 12, 16, and 24 weeks)
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)
24 weeks (at 2, 4, 8, 12, 16, and 24 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Michelle Abou-Jaoude

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Inflammasome Therapeutics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michelle Abou-Jaoude, MD, University Of Kentucky

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 4, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 20, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 23, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 79071

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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