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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
No Placebo-Only Group
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.
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.
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)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adverse Events
Mean change in best-corrected visual acuity (BCVA)
Mean change in central subfield thickness
Secondary study objectives
Change in foveal avascular zone.
Change in hard exudates
Change in retinal thickening
+8 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Patients with Diabetic Macular EdemaExperimental Treatment1 Intervention
Patients with Diabetic Macular Edema
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Who is running the clinical trial?
Michelle Abou-JaoudeLead Sponsor
Inflammasome TherapeuticsUNKNOWN
2 Previous Clinical Trials
13 Total Patients Enrolled
Michelle Abou-Jaoude, MDPrincipal InvestigatorUniversity of Kentucky
1 Previous Clinical Trials
5 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had or currently have a viral infection in my eye.I am allergic to fluorescein or parts of the treatment being studied.I don't have any health issues that would stop me from participating in the study according to my doctor.I have abnormal blood vessels in my eye not caused by diabetes.My eye pressure is 21 or lower and I use 2 or fewer medications for it.I am 18 years old or older.I am not pregnant, breastfeeding, or if capable of becoming pregnant, I am using reliable contraception.My steroid treatment hasn't changed in the last 3 months.I have had a vitrectomy in my eye being studied.I do not have a natural lens in my study eye.I have had treatments for diabetic eye disease involving the eye or surrounding areas.I have a clear eye condition that affects my vision.I have type 1 or 2 diabetes with a specific eye condition related to diabetes.I haven't had eye surgery in the past 3 months.I have had laser treatment for diabetic eye disease in the last 12 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Patients with Diabetic Macular Edema
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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