Diabetic Macular EdemaPhase 1NCT05699759
Safety and Effect of Intravitreal Injection of a Derivative of Nucleoside Reverse Transcriptase Inhibitor in Subjects with Diabetic Macular Edema
A Phase 1 study testing K8 in people with Diabetic Macular Edema, run by Michelle Abou-Jaoude at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- K8
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2024to 20 Jun 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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.)
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Diabetic Macular Edema
- Being tested
- K8
- Keywords
- diabetes, kamuvudine, K8, SOM-401
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
K8Drug
Also called SOM-401
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).
| Study group | Role | What they receive |
|---|---|---|
| Patients with Diabetic Macular Edema | Experimental | Patients with Diabetic Macular Edema Receives: Drug: K8 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in central subfield thickness
Central subfield thickness (CST) measured on spectral domain-optical coherence tomography (SD-OCT)
Measured: At week 4 (change as measured from baseline)
Mean change in best-corrected visual acuity (BCVA)
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: At week 4 (change as measured from baseline)
Adverse Events
Frequency of participants experiencing ocular or systemic adverse events.
Measured: Within the study period (of 24 weeks)
Secondary outcomes (11)
Resolution of macular edema
Frequency of participants experiencing resolution of macular edema
Measured: 24 weeks (at 2, 4, 8, 12, 16, and 24 weeks)
Clinically significant change in visual acuity
Frequency of participants experiencing clinically significant change.
Measured: 24 weeks (at 2, 4, 8, 12, 16, and 24 weeks)
Change in score on the ETDRS Multi-Step Scale of Diabetic Retinopathy
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.
Measured: 24 weeks
Visual acuity
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.
Measured: 24 weeks (at 2, 4, 8, 12, 16, and 24 weeks)
Change in retinal thickening
Total area in disc diameters of retinal thickening of the lesion involving the foveal center, based on fundus imaging.
Measured: 24 weeks (at 2, 4, 8, 12, 16, and 24 weeks)
Change in hard exudates
Total area in disc diameters of hard exudates in the lesion involving the macula, based on fundus imaging.
Measured: 24 weeks (at 2, 4, 8, 12, 16, and 24 weeks)
Change in foveal avascular zone.
Foveal avascular zone size as determined using OCT-Angiography
Measured: 24 weeks (at 2, 4, 8, 12, 16, and 24 weeks)
Proportion of subjects requiring rescue treatment
Proportion of subjects requiring rescue treatment
Measured: 24 weeks (at 2, 4, 8, 12, 16, and 24 weeks)
Proportion of subjects requiring vitrectomy
Proportion of subjects requiring vitrectomy
Measured: 24 weeks (at 2, 4, 8, 12, 16, and 24 weeks)
Mean change in central subfield thickness at other study timepoints
Central subfield thickness (CST) measured on spectral domain-optical coherence tomography (SD-OCT)
Measured: 24 weeks (at 2, 8, 12, 16, and 24 weeks)
Mean change in best-corrected visual acuity (BCVA) at other study timepoints
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: 24 weeks (at 2, 4, 8, 12, 16, and 24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start4 Jan 2024
- Primary completion20 Jun 2024
- Study completion20 Jun 2024
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
- NCT05699759
- Sponsor's protocol ID
- 79071
- Status last verified
- Oct 2024
- First submitted
- 23 Dec 2022
- Last updated
- 1 Nov 2024
- 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 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05699759
- Acronym / sponsor ID
- 79071
- Conditions
- Diabetic Macular Edema
- Keywords
- diabetes, kamuvudine, K8, SOM-401
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Michelle Abou-JaoudeUniversity, hospital or other
- Collaborators
- Inflammasome Therapeutics
- Study start
- 4 Jan 2024 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 26 Jan 2023 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Diabetic Macular Edema | Experimental | Drug: K8Patients with Diabetic Macular Edema |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (15 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.)
- 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
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 |
|---|---|---|
| K8Also: SOM-401Subjects 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). | Drug | Patients with Diabetic Macular Edema |
Primary outcome
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)
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)
Adverse Events
Time frame: Within the study period (of 24 weeks)
Frequency of participants experiencing ocular or systemic adverse events.
11 secondary outcomes
Resolution of macular edema
Time frame: 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)
Change in score on the ETDRS Multi-Step Scale of Diabetic Retinopathy
Time frame: 24 weeks
Visual acuity
Time frame: 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)
Change in hard exudates
Time frame: 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)
Proportion of subjects requiring rescue treatment
Time frame: 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)
Mean change in central subfield thickness at other study timepoints
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- 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 K8 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 8 inclusion and 15 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: finished, as of the sponsor's last update on 1 Nov 2024. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean change in central subfield thickness (time frame: At week 4 (change as measured from baseline)). 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 1 Nov 2024.