Diabetic Macular EdemaPhase 1/2K9NCT07458061
Kamuvudine-9 (K9) in Diabetic Macular Edema
A Phase 1/2 study testing Kamuvudine K9 in people with Diabetic Macular Edema, run by Dr. Bryan Strelow at 1 site in United States.
Trial summary
The objectives of this investigation are to assess: 1. whether oral K9 is safe in subjects with DME, and 2. whether oral K9 improves BCVA compared to oral placebo 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?
- Kamuvudine K9
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2026to Aug 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- Aged 18 years or older.
- 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 evident on fundus photographs, fluorescein angiograms, or spectral domain-optical coherence tomography (SD-OCT)
- HbA1c of ≤12% at screening.
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- BCVA of ≥ 24 and ≤ 68 letters (20/50 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).
- Mean central subfield thickness (CST) of at least 325 µm by SD-OCT.
- Intraocular pressure of ≤ 21 mm Hg on 2 or fewer IOP lowering medications.
- Capable of providing informed consent.
- Capable and willing to follow study protocol.
- Females of childbearing potential must agree to abstain from sex or use adequate method of contraception for the duration of the study period and for 28 days after the last dose of study drug.
- Males must agree to abstain from sex or use adequate method of contraception for the duration of the study period and for 28 days after the last dose of study drug.
Who cannot join
- Body weight < 55 kg.
- Macular edema considered to be due to causes other than diabetes.
- Proliferative diabetic retinopathy or iris neovascularization (including the anterior chamber angle) in the study eye.
- Inability to follow the study protocol, based on the investigator's assessment.
- Females who are pregnant or breastfeeding.
- Panretinal or scatter laser photocoagulation within 12 months of screening.
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- Topical steroid or topical NSAID in the study eye or oral NSAID treatment within 30 days of screening.
- Active ocular inflammation of any history of intraocular inflammation within 1 year.
- 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 6 weeks of screening Intravitreous or sub-Tenon delivery of steroid therapy (e.g. triamcinolone, dexamethasone) within 12 months or fluocinolone acetonide implant within 3 years of screening.
- Macular laser for the treatment of DME within 6 months of screening
- Aphakia or total absence of the posterior capsule in the study eye.
- Yttrium aluminium garnet (YAG) laser capsulotomy in the study eye within 2 months of screening.
- Any change in systemic steroid therapy within 3 months of screening.
- Any ocular surgery in the study eye within 12 weeks of screening.
- Presence of severe foveal ischemia in the study eye, defined as foveal avascular zone (FAZ) of >1.5 mm2 on OCT-Angiography (OCT-A) or fluorescein angiography (FA).
- 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), age-related macular degeneration) in the study eye.
- 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 in the study eye.
- 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 in the study eye that could affect interpretation of study assessments (e.g., but not limited to, geographic atrophy, macular hole, macular pucker, foveomacular traction, retinal vein occlusion, retinal degenerations), in the opinion of the investigator.
- Any lens or corneal opacity in the study eye which impairs visualization of the posterior pole of the retina, in the opinion of the investigator.
- History or current evidence of hypersensitivity to any components of the study medication, as assessed by the investigator.
- Taking any medications containing nucleotide reverse transcriptase inhibitors (NRTIs), including but not limited to Abacavir, Emtricitabine, Lamivudine, or Zidovudine; trade names Atripla, Biktarvy, Cimduo, Combivir, Complera, Delstrigo, Descovy, Dovato, Emtriva, Epivir, Epzicom, Genvoya, Odefsey, Retrovir, Stribild, Symfi, Symtuza, Triumeq, Trizivir, Truvada, Ziagen.
- History of taking medications with known retinal toxicity (e.g., hydroxychloroquine, chloroquine, pentosan polysulfate sodium, and amiodarone).
- Clinically significant unstable medical condition (other than diabetes) that would pose a risk to the participant, according to investigator's judgment (e.g., cardiovascular instability, systemic infection), or clinically significant laboratory abnormality.
- Clinically significant abnormal liver or kidney function at screening. The following values [alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal (ULN) or estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73m2] are exclusionary regardless of clinical symptoms.
- Active cancer or history of cancer, except for the following: basal cell carcinoma or successfully treated squamous cell carcinoma of the skin, cervical carcinoma in situ, prostatic carcinoma in situ, or other malignancies curatively treated and with no evidence of disease recurrence for at least 3 years.
- Treatment with other investigational drug within 6 weeks or 5 half-lives of drug prior to screening, whichever is longer.
- Participation in another clinical trial within 12 weeks before the screening visit or during the study (participation in clinical trials solely involving observation, over-the-counter vitamins, supplements, or diets are not exclusionary).
- Plans to move away from study site within the next 2 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vistar Eye Center
Roanoke, Virginia, 24019
Mary Galyen, BS, COA, 826-867-8808, mgalyen@vistareye.com
Bryan Strelow, MD, 540-855-5100 ext. 4723, bstrelow@vistareye.com
About this study
Official title: Randomized Trial of Kamuvudine-9 (K9) in DME
The objectives of this investigation are to assess:
- whether oral K9 is safe in subjects with DME, and
- whether oral K9 improves BCVA compared to oral placebo
- Conditions
- Diabetic Macular Edema
- Being tested
- Placebo Tablet: BID, Kamuvudine K9
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo Tablet: BIDDrug
Placebo tablets BID
Kamuvudine K9Drug
Kamuvudine K9
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group 1 | Placebo comparator | Placebo tablets Receives: Drug: Placebo Tablet: BID |
| Kamuvudine Group 2 | Experimental | Kamuvudine tablets BID Receives: Drug: Kamuvudine K9 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v6.0
Number of participants with treatment-related adverse events as assessed by CTCAE v6.0.
Measured: 4 weeks
Change from baseline Best-Corrected Visual Acuity measured using the standardized ETDRS chart
To evaluate the effects of K9 based on change from baseline Best-Corrected Visual Acuity measured using the standardized ETDRS chart
Measured: 4 weeks
Secondary outcomes (1)
Changes in structural outcomes measured using OCT CST
Changes in structural outcomes measured using OCT CST (in microns)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study startFeb 2026 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionAug 2026 (estimated)
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Bryan Strelow
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Bryan Strelow, Vistar Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07458061
- Sponsor's protocol ID
- K9-201
- Acronym
- K9
- Status last verified
- Mar 2026
- First submitted
- 19 Feb 2026
- Last updated
- 10 Mar 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 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Kamuvudine-9 (K9) in DME
- ClinicalTrials.gov ID
- NCT07458061
- Acronym / sponsor ID
- K9 / K9-201
- Conditions
- Diabetic Macular Edema
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Dr. Bryan StrelowUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 9 Mar 2026 (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.
The objectives of this investigation are to assess:
- whether oral K9 is safe in subjects with DME, and
- whether oral K9 improves BCVA compared to oral placebo
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Group 1 | Placebo comparator | Drug: Placebo Tablet: BIDPlacebo tablets |
| Kamuvudine Group 2 | Experimental | Drug: Kamuvudine K9Kamuvudine tablets BID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Aged 18 years or older.
- 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 evident on fundus photographs, fluorescein angiograms, or spectral domain-optical coherence tomography (SD-OCT)
Key exclusion criteria (30 listed)
- Body weight < 55 kg.
- Macular edema considered to be due to causes other than diabetes.
- Proliferative diabetic retinopathy or iris neovascularization (including the anterior chamber angle) in the study eye.
- Inability to follow the study protocol, based on the investigator's assessment.
- Females who are pregnant or breastfeeding.
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 |
|---|---|---|
| Placebo Tablet: BIDPlacebo tablets BID | Drug | Placebo Group 1 |
| Kamuvudine K9Kamuvudine K9 | Drug | Kamuvudine Group 2 |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v6.0
Time frame: 4 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v6.0.
Change from baseline Best-Corrected Visual Acuity measured using the standardized ETDRS chart
Time frame: 4 weeks
To evaluate the effects of K9 based on change from baseline Best-Corrected Visual Acuity measured using the standardized ETDRS chart
1 secondary outcome
Changes in structural outcomes measured using OCT CST
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Diabetic Macular Edema
Active, not recruitingObservational study
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A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Kamuvudine K9 in people with Diabetic Macular Edema, run by Dr. Bryan Strelow 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 13 inclusion and 30 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: looking for participants now, as of the sponsor's last update on 10 Mar 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary Galyen, BS, COA (826-867-8808, mgalyen@vistareye.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v6.0 (time frame: 4 weeks). The study lists 2 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 10 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.