This randomized clinical trial will evaluate the effect of tonabersat compared with placebo on central subfield thickness (CST) in eyes with center-involved diabetic macular edema (CI-DME) and good visual acuity.
The primary objective is to assess the effects of tonabersat, an orally administered Connexin43 hemichannel inhibitor, on central subfield thickness (mean change) compared with placebo in eyes with CI-DME and good visual acuity at 6 months. Exploratory objectives will evaluate biomarkers of kidney function for potential benefit. Furthermore, this phase 2 study is being conducted to determine whether the conduct of a phase 3 trial has merit and provide information on outcome measures needed to design a phase 3 trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
128
Two pills of Study Drug (80 mg tonabersat) is taken orally once daily. It is recommended the Study Drug be taken at bedtime. The first dose (two pills) will be taken at bedtime on the day the participant is randomized.
Two pills of Study Drug (placebo) is taken orally once daily. It is recommended the Study Drug be taken at bedtime. The first dose (two pills) will be taken at bedtime on the day the participant is randomized.
Mean change in central subfield thickness
Time frame: 6 months
Mean change in retinal volume from baseline
Time frame: 6 months
Percentage of eyes central subfield thickness below optical coherence machine- and sex-specific threshold for DME and at least a 10% decrease from baseline
Composite outcome, gender-specific spectral domain optical coherence tomography equivalent of 250 µm on Zeiss Stratus optical coherence tomography
Time frame: 6 months
Mean change in visual acuity from baseline
Time frame: 6 months
Percentage of eyes receiving other treatment for DME prior to the 6 month visit
Time frame: 6 months
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