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
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
Treatments tested in this trial
- Placebo Tablet: BID
- Kamuvudine K9
Treatment groups
10 Participants
are divided into 2 treatment groupsSponsors and collaborators
Dr. Bryan Strelow
Lead sponsor
Vistar Eye Center
Sponsor institution
Source ClinicalTrials.gov