Diabetic Macular EdemaPhase 1NCT06781255
Evaluation of K9 in Subjects With Diabetic Macular Edema (DME)
A Phase 1 study testing Kamuvudine-9 in people with Diabetic Macular Edema, run by Michelle Abou-Jaoude at 1 site in United States.
Trial summary
A non-randomized study evaluating the safety of an orally administered inflammasome inhibitor, K9, for the treatment of diabetic macular edema (DME). Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Kamuvudine-9
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2025to 25 Feb 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 Snellen equivalent)
- Diagnosis of diabetes mellitus, type 1 or 2 with non-proliferative or non-high risk proliferative diabetic retinopathy. Any one of the following will be considered sufficient evidence that diabetes is present:
- Current regular use of insulin for the treatment of diabetes
- Current regular use of oral hypoglycemic agents for the treatment of diabetes
- DME based on investigator's clinical evaluation and demonstrated on fundus photographs, fluorescein angiograms, and/or spectral domain-optical coherence tomography (SD-OCT)
- Mean foveal thickness of at least 325 µm by SD-OCT
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- 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 mm Hg on 2 or fewer IOP lowering medications
Who cannot join
- 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.
- Body weight less than 55 kg
- 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
- History of vitrectomy in the study eye
- Aphakia in the study eye
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- 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 including any of the following:
- Intravitreous injection of anti-VEGF therapies including but not limited to bevacizumab, ranibizumab, aflibercept, faricimab, and/or brolucizumab within the last 1 month
- Intravitreous or sub-Tenon delivery of any steroid therapy (such as triamcinolone, dexamethasone) in the last 6 months or a fluocinolone acetonide implant for 3 years.
- Macular laser for the treatment of diabetic macular edema within 6 months 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 (e.g. presumed ocular histoplasmosis, high myopia (spherical equivalent greater than 8 diopters), macular degeneration)
- History or presence of viral disease of the cornea or conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, any mycobacterial infections of the eye, or any fungal disease of any ocular structure or history of infectious retinitis
- 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.
- History or presence of any other condition except for DME that could affect interpretation of study assessments (for example, but not limited to, geographic atrophy, macular hole, macular pucker, foveomacular traction, retinal vein occlusion, retinal degenerations)
- 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
- History of any clinically significant medical disorders the principal investigator considers exclusionary, including (but not limited to), neuromuscular, hematological disease, immune deficiency state, respiratory disease, hepatic or gastrointestinal disease, neurological or psychiatric disease, neoplastic disease, renal or urinary tract diseases, or dermatological disease.
- History or current evidence of hypersensitivity to any components of the study medication, as assessed by the investigator.
- Participation in any systemic experimental treatment or any other systemic investigational new drug within 6 weeks or 5 half-lives of the active ingredient (whichever is longer) prior to the start of study treatment. Clinical trials solely involving observation, over-the-counter vitamins, supplements, or diets are not exclusionary.
- 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
Trial locations and contacts
1 site in 1 country.
About this study
A non-randomized study evaluating the safety of an orally administered inflammasome inhibitor, K9, for the treatment of diabetic macular edema (DME).
Read the detailed description
This is an twenty-eight (28) week non-randomized, open-label, safety study evaluating twice daily, oral K9 in five (5) patients. Subjects with DME meeting inclusion/exclusion criteria will be offered enrollment into this study. A screening visit and subject selection criteria will be used to assess subject eligibility prior to enrollment. Patients will be supplied with tablets of K9 to be taken orally BID for 24 weeks. Safety will be assessed over a series of visits over an 28 week period.
- Conditions
- Diabetic Macular Edema
- Being tested
- Kamuvudine-9
- Keywords
- Diabetic Macular Edema, Kamuvudine-9
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kamuvudine-9Drug
96 mg tablets taken twice a day for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Subjects with DME | Experimental | Patients will receive a regimen of 96 mg tablets of K9 to be taken twice a day for 24 weeks. Receives: Drug: Kamuvudine-9 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Frequency of participants experiencing ocular or systemic adverse events.
Measured: 28 weeks
Change from baseline in central subfield thickness (CST)
Central subfield thickness (CST) measured on spectral domain-optical coherence tomography (SD-OCT)
Measured: Screening (baseline), Day 1 Visit, and weeks 6, 12, 18, and 24
Mean change from baseline in best corrected visual acuity (BCVA)
Mean change from baseline assessed by the ETDRS chart. 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)
Measured: Screening (baseline), Day 1 Visit, and weeks 6, 12, 18, and 24
Secondary outcomes (4)
Change from baseline in macular volume on spectral domain-optical coherence tomography (SD-OCT)
This equipment is used to take photos of the retina layer of the eye and provides two- and three-dimensional images by using near-infrared, broad-bandwidth light source to illuminate the retina. This will be used to look for mean changes from baseline for a change in conditions in eyesight.
Measured: Screening (baseline), Day 1 Visit, and weeks 6, 12, 18, and 24
Change from baseline in retinal thickening on fundus photography
This equipment is used to take high-resolution, ultra-wide field images of the retina to look at the entirety of the back of the eye. This will be used to look for mean changes from baseline for a change in conditions in eyesight
Measured: Screening (baseline), and weeks 6, 12, 18, and 24
Change from baseline in hard exudates in lesion involving the macula on fundus photography
This equipment is used to take high-resolution, ultra-wide field images of the retina to look at the entirety of the back of the eye. This will be used to look for mean changes from baseline for a change in conditions in eyesight
Measured: Screening (baseline), and weeks 6, 12, 18, and 24
Change from baseline in foveal avascular zone on optical coherence tomography angiography (OCT-A)
This equipment is used to take photos of multiple layers of the back of your eye and depicts blood vessels and other structures to help the study doctor measure changes from the baseline in your eyesight.
Measured: Screening (baseline), and weeks 6, 12, 18, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start13 Mar 2025
- Primary completion25 Feb 2026
- Study completion25 Feb 2026
Why it stopped: Low recruitment outcome
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michelle Abou-Jaoude
- Sponsor type
- University, hospital or other
- Collaborators
- Inflammasome Therapeutics
- Responsible party
- Sponsor-investigator, Michelle Abou-Jaoude, University of Kentucky
- Investigators
- Michelle Abou-Jaoude, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06781255
- Sponsor's protocol ID
- 100315
- Status last verified
- Mar 2026
- First submitted
- 13 Jan 2025
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of K9 in Subjects With Diabetic Macular Edema (DME)
- ClinicalTrials.gov ID
- NCT06781255
- Acronym / sponsor ID
- 100315
- Conditions
- Diabetic Macular Edema
- Keywords
- Diabetic Macular Edema, Kamuvudine-9
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment outcome
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Michelle Abou-JaoudeUniversity, hospital or other
- Collaborators
- Inflammasome Therapeutics
- Study start
- 13 Mar 2025 (actual)
- Primary completion
- 25 Feb 2026 (actual)
- Study completion
- 25 Feb 2026 (actual)
- First posted
- 17 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A non-randomized study evaluating the safety of an orally administered inflammasome inhibitor, K9, for the treatment of diabetic macular edema (DME).
Detailed description
This is an twenty-eight (28) week non-randomized, open-label, safety study evaluating twice daily, oral K9 in five (5) patients. Subjects with DME meeting inclusion/exclusion criteria will be offered enrollment into this study. A screening visit and subject selection criteria will be used to assess subject eligibility prior to enrollment. Patients will be supplied with tablets of K9 to be taken orally BID for 24 weeks. Safety will be assessed over a series of visits over an 28 week period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with DME | Experimental | Drug: Kamuvudine-9Patients will receive a regimen of 96 mg tablets of K9 to be taken twice a day for 24 weeks. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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 Snellen equivalent)
- Diagnosis of diabetes mellitus, type 1 or 2 with non-proliferative or non-high risk proliferative diabetic retinopathy. Any one of the following will be considered sufficient evidence that diabetes is present:
- Current regular use of insulin for the treatment of diabetes
- Current regular use of oral hypoglycemic agents for the treatment of diabetes
- DME based on investigator's clinical evaluation and demonstrated on fundus photographs, fluorescein angiograms, and/or spectral domain-optical coherence tomography (SD-OCT)
Key exclusion criteria (22 listed)
- 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.
- Body weight less than 55 kg
- 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
- History of vitrectomy in the study eye
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kamuvudine-996 mg tablets taken twice a day for 24 weeks | Drug | Subjects with DME |
Primary outcome
Adverse Events
Time frame: 28 weeks
Frequency of participants experiencing ocular or systemic adverse events.
Change from baseline in central subfield thickness (CST)
Time frame: Screening (baseline), Day 1 Visit, and weeks 6, 12, 18, and 24
Central subfield thickness (CST) measured on spectral domain-optical coherence tomography (SD-OCT)
Mean change from baseline in best corrected visual acuity (BCVA)
Time frame: Screening (baseline), Day 1 Visit, and weeks 6, 12, 18, and 24
Mean change from baseline assessed by the ETDRS chart. 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)
4 secondary outcomes
Change from baseline in macular volume on spectral domain-optical coherence tomography (SD-OCT)
Time frame: Screening (baseline), Day 1 Visit, and weeks 6, 12, 18, and 24
Change from baseline in retinal thickening on fundus photography
Time frame: Screening (baseline), and weeks 6, 12, 18, and 24
Change from baseline in hard exudates in lesion involving the macula on fundus photography
Time frame: Screening (baseline), and weeks 6, 12, 18, and 24
Change from baseline in foveal avascular zone on optical coherence tomography angiography (OCT-A)
Time frame: Screening (baseline), and weeks 6, 12, 18, and 24
Results and safety
The study was stopped early (reason given: Low recruitment outcome). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Abou-Jaoude, MD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Kamuvudine-9 in people with Diabetic Macular Edema, run by Michelle Abou-Jaoude at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Low recruitment outcome). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: 28 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.