Phase 2 study to assess the efficacy of topically administered eyedrops of INV-102 during a 12-week dosing period in subjects with non-center involved DME (NCIDME) associated with NPDR \[Part 1\] and during an 8-week dosing period in subjects with center-involved DME (CIDME) associated with NPDR \[Part 2\].
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
19
0.7% Ophthalmic Solution
MedTrials, Inc.
Dallas, Texas, United States
Change from baseline in the Early Treatment Diabetic Retinopathy (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) score
Graded by an independent central reading center using Wide-field Color Fundus Photography. The DRSS divides diabetic retinopathy into levels ranging from absence of retinopathy (score = 10) to advanced retinopathy (score = 85). The scale is used to describe overall retinopathy severity as well as the change in severity over time.
Time frame: Day 84 (Part 1) and Day 56 (Part 2)
Change from baseline in central subfield thickness (Part 2 only)
Measured using spectral domain optical coherence tomography (SD-OCT) and determined by an independent central reading center.
Time frame: Day 56
Change from baseline in macular volume
Measured using spectral domain optical coherence tomography (SD-OCT)
Time frame: Day 84 (Part 1) and Day 56 (Part 2)
Change from baseline in subfield thickness
Mean retinal thickness in each of the regional subfields of the ETDRS grid, measured using SD-OCT
Time frame: Day 84 (Part 1) and Day 56 (Part 2)
Change from baseline in the retinal thickness at the thickest point of the subfield thickness
Measured using SD-OCT in each of the regional subfields of the ETDRS grid
Time frame: Day 84 (Part 1) and Day 56 (Part 2)
Change in best corrected visual acuity (BCVA) (Part 2 only)
Time frame: Day 56
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