← Back to Search

Nucleoside Reverse Transcriptase Inhibitor

K8 for Diabetic Macular Edema

Phase 1

Recruiting

Led By Michelle Abou-Jaoude, MD

Research Sponsored by Michelle Abou-Jaoude

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study Summary

This trial tests a new drug for treating eye damage from diabetes, to see if it's safe and effective. #diabetes #medicine

Who is the study for?

Adults with diabetes (type 1 or 2) who have diabetic macular edema (DME), a type of eye swelling. They must have certain levels of retinal thickness and vision range, be able to follow the study's procedures, and not be pregnant or planning pregnancy without effective contraception. Excluded are those with recent eye surgery, vitrectomy history, severe foveal ischemia, prior DME treatments within specific timeframes, changes in steroidal therapy recently, other ocular conditions or diseases that might interfere with the treatment.Check my eligibility

What is being tested?

The trial is testing SOM-401 (K8), a new compound related to drugs used for HIV/AIDS but here aimed at treating DME. Participants will receive injections into their eyes to see if it's safe and helps reduce swelling caused by DME.See study design

What are the potential side effects?

While the side effects aren't listed explicitly here, typical risks from similar eye injections include redness, discomfort at injection site, increased pressure inside the eye which can lead to glaucoma if unchecked; there may also be potential allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks (at 2, 4, 8, 12, 16, and 24 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse Events

Mean change in best-corrected visual acuity (BCVA)

Mean change in central subfield thickness

Secondary outcome measures

Change in foveal avascular zone.

Change in hard exudates

Change in retinal thickening

+8 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Patients with Diabetic Macular EdemaExperimental Treatment1 Intervention

Patients with Diabetic Macular Edema

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Michelle Abou-JaoudeLead Sponsor

Inflammasome TherapeuticsUNKNOWN

1 Previous Clinical Trials

5 Total Patients Enrolled

Michelle Abou-Jaoude, MDPrincipal InvestigatorUniversity of Kentucky

1 Previous Clinical Trials

5 Total Patients Enrolled

Media Library

K8 (Nucleoside Reverse Transcriptase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05699759 — Phase 1

Diabetic Macular Edema Research Study Groups: Patients with Diabetic Macular Edema

Diabetic Macular Edema Clinical Trial 2023: K8 Highlights & Side Effects. Trial Name: NCT05699759 — Phase 1

K8 (Nucleoside Reverse Transcriptase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05699759 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there known risks associated with diabetic macular edema treatment?

"Since this is a Phase 1 trial, with limited data supporting efficacy and safety, our team at Power have conservatively assigned Diabetic Macular Edema a score of 1."

Answered by AI

What is the aggregate figure of participants in this clinical trial?

"Affirmative, clinicaltrials.gov data reveals that this research project is currently enrolling participants. It was first made public on the 28th of February 2023 and recently updated on March 13th 2023. Five volunteers are sought for recruitment at one medical facility."

Answered by AI

Are there any vacancies in this research endeavor for prospective participants?

"Affirmative. Details hosted on clinicaltrials.gov indicate that the research is currently recruiting, having been posted on February 28th 2023 and most recently updated March 13th 2023. This study requires 5 patients to be recruited from a single medical site."

Answered by AI

What are the objectives of this clinical trial?

"This medical study seeks to evaluate the mean change in central subfield thickness at week 4, compared to baseline. Secondary outcomes include a clinically significant alteration of visual acuity (as determined by frequency of participants experiencing such an effect) as well as best-corrected visual acuity at other timepoints and changes in hard exudates total area measured in disc diameters."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Michelle Abou-Jaoude 2023. "Safety and Effect of Intravitreal Injection of a Derivative of Nucleoside Reverse Transcriptase Inhibitor in Subjects With Diabetic Macular Edema". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05699759.

All > Macular Edema > Diabetes