The objective of this study is to evaluate the safety and efficacy of APX3330 to treat diabetic retinopathy (DR) and diabetic macular edema (DME).
The objective of this study is to evaluate the efficacy of APX3330 to improve Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Score (DRSS) in one hundred (100) subjects with moderately severe to severe NPDR or mild PDR. Subjects with moderately severe to severe NPDR and mild PDR will be selected for study participation and be screened for study eligibility. The eligible eye with the highest DRSS, as assessed by the central reading center, will be designated as the study eye for the primary efficacy analysis. If the subject meets all eligibility criteria, then the subject will be randomized into the study and receive study medication. Blood will be drawn for biomarker analysis. The total length of subject participation is approximately 26 weeks, with 5 clinic visits, 4 telephone safety calls, and one telephone call follow-up visit. The execution of the entire study (first subject screen through last randomized subject completed) is expected to be approximately 12 to 15 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
103
APX3330, a small-molecule oral tablet, is a Ref-1 inhibitor that can potentially reduce proinflammatory and hypoxic signaling that contributes to several eye diseases.
Placebo tablets are identical to APX3330 tablets except for the absence of the active pharmaceutical ingredient.
Clinical Site 9
Phoenix, Arizona, United States
Percent of Subjects with an improvement in Diabetic Retinopathy Severity Score (DRSS)
Percent of subjects with a ≥ 2-step improvement in DRSS in the study eye
Time frame: 24 Weeks
Percent of Subjects with change in Diabetic Retinopathy Severity Scale (DRSS) Scores
Percent of subjects with an improvement or worsening in DRSS of ≥ 1, ≥ 2, ≥ 3, and ≥ 4 steps at Week 12 and Week 24
Time frame: Up to 24 Weeks
Mean Change in Diabetic Retinopathy Severity Scale (DRSS) Score
Mean change from baseline in DRSS at Week 24. DRSS is scored on a range from 10 to 90 with 13 discrete scores given within that range and where higher scores indicate a worse outcome.
Time frame: 24 Weeks
Percent of Subjects without DR/DME Disease Progression
Percent of subjects not developing center-involved DME or moderate PDR or PDR-related AEs during the study at Week 12 and Week 24
Time frame: 24 Weeks
Mean Change in Best-Corrected Visual Acuity (BCVA)
Mean change in BCVA at Week 24
Time frame: 24 Weeks
Mean Change in Central Subfield Thickness (CST)
Mean Change in CST at Week 24
Time frame: 24 Weeks
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Clinical Site 2
Sacramento, California, United States
Clinical Site 24
Walnut Creek, California, United States
Clinical Site 19
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Clinical Site 6
Carmel, Indiana, United States
Clinical Site 14
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...and 14 more locations