The purpose of the study is to determine whether concentrations of FOV2304 (high dose or low dose) administered in the eye are more effective than placebo in treating patients with diabetic macular edema, following 12 weeks of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
267
2304 Eye Drops High Dose self-administered in the study eye during the treatment period
2304 Eye Drops Low Dose self-administered in the study eye during the treatment period
Placebo Eye Drops self-administered in the study eye during the treatment period
change from baseline of central retinal thickness as determined by logOCT
Time frame: Week 12
Proportion of patients with an improvement in best corrected visual acuity (BCVA)
Time frame: Week 12
Change in macular volume and retinal thickness from baseline to Week 12 and Week 24
Time frame: Baseline, Week 12, Week 24
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