Health TrialsbyHealthPanel

Kamuvudine-9 (K9) in Diabetic Macular Edema

ConditionDiabetic Macular Edema
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDr. Bryan Strelow

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 years or older.

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)

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Placebo Tablet: BID

    Drug

    Placebo tablets BID

  • Kamuvudine K9

    Drug

    Kamuvudine K9

Treatment groups

10 Participants
are divided into 2 treatment groups
Group A: Placebo Group 1Placebo comparator 1 intervention
Group B: Kamuvudine Group 2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
4 weeks
2

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

Time frame
4 weeks

Secondary outcomes

1

Changes in structural outcomes measured using OCT CST

Changes in structural outcomes measured using OCT CST (in microns)

Time frame
4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dr. Bryan Strelow

Lead sponsor

Vistar Eye Center

Sponsor institution

Source ClinicalTrials.gov
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