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Could a pill replace eye injections for Diabetes-Related vision loss?

NCT ID NCT07458061

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial is testing an oral drug called Kamuvudine-9 (K9) in 10 adults with diabetic macular edema, a condition that causes vision loss. The study aims to see if K9 is safe and whether it improves vision compared to a placebo. Participants will take either K9 or placebo tablets twice a day, and researchers will monitor side effects and changes in eyesight.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Kamuvudine-9 (K9)
What this could lead to
If it works, this could point toward a new oral treatment for diabetic macular edema, potentially reducing the need for eye injections.
What could go wrong
This is a very early Phase 1/2 trial with only 10 participants, so results may not apply broadly. The drug may prove unsafe or no better than placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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. * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Vistar Eye Center

    RECRUITING

    Roanoke, Virginia, 24019, United States

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Other studies related to the condition(s) this trial covers.