Kamuvudine-9 (K9) in Diabetic Macular Edema

NCT07458061 | Recruiting Phase 1 FDA Drug

• 1 other identifier: K9-201
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this investigation are to assess:

1. 1.whether oral K9 is safe in subjects with DME, and
2. 2.whether oral K9 improves BCVA compared to oral placebo

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  4 weeks

Secondary Outcomes (1)

• Changes in structural outcomes measured using OCT CST

  4 weeks

Study Arms (2)

Placebo Group 1

PLACEBO COMPARATOR

Placebo tablets

Drug: Placebo Tablet: BID

Kamuvudine Group 2

EXPERIMENTAL

Kamuvudine tablets BID

Drug: Kamuvudine K9

Interventions

Placebo Tablet: BID DRUG

Placebo tablets BID

Placebo Group 1

Kamuvudine K9 DRUG

Kamuvudine K9

Kamuvudine Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Bryan Strelow: lead

Study Sites (1)

Vistar Eye Center

Roanoke, Virginia, 24019, United States

RECRUITING

Central Study Contacts

Mary Galyen, BS, COA

CONTACT

826-867-8808; mgalyen@vistareye.com

Bryan Strelow, MD

CONTACT

540-855-5100; bstrelow@vistareye.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: March 9, 2026
• Study Start: February 1, 2026
• Primary Completion: June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)