Center-involved Diabetic Macular Edema, Center-involved Diabetic Macular Edema Associated With Non-proliferative Diabetic Retinopathy, Diabetic Retinopathy, Non-center Involved Diabetic Macular Edema, Non-center Involved Diabetic Macular Edema Associated With Non-proliferative Diabetic Retinopathy
Conditions
Brief summary
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 \[Part 2\].
Interventions
DRUGINV-102
0.7% Ophthalmic Solution
Sponsors
Invirsa, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Male or female subjects ≥ 18 years of age and \< 76 years of age * Diagnosed with diabetes (Type 1 or 2) with hemoglobin A1c ≤ 12.0% * Study eye must have NCIDME (Part 1) or CIDME (Part 2) * Study eye must be moderate to severe NPDR Key
Exclusion criteria
* Prior laser treatment for DR in the study eye within 12 months from Screening Visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the Early Treatment Diabetic Retinopathy (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) score | Day 84 (Part 1) and Day 56 (Part 2) | 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. |
| Change from baseline in central subfield thickness (Part 2 only) | Day 56 | Measured using spectral domain optical coherence tomography (SD-OCT) and determined by an independent central reading center. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in macular volume | Day 84 (Part 1) and Day 56 (Part 2) | Measured using spectral domain optical coherence tomography (SD-OCT) |
| Change from baseline in subfield thickness | Day 84 (Part 1) and Day 56 (Part 2) | Mean retinal thickness in each of the regional subfields of the ETDRS grid, measured using SD-OCT |
| Change from baseline in the retinal thickness at the thickest point of the subfield thickness | Day 84 (Part 1) and Day 56 (Part 2) | Measured using SD-OCT in each of the regional subfields of the ETDRS grid |
| Change in best corrected visual acuity (BCVA) (Part 2 only) | Day 56 | — |
Countries
United States
Contacts
STUDY_CHAIRRobert Shalwitz
Invirsa, Inc.
Outcome results
None listed