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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].
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: INV-102 0.7% in NCIDME | Experimental | INV-102 0.7% Ophthalmic Solution given three times daily (TID) for 2 weeks followed by twice daily (BID) for 10 weeks |
|
| Part 2: INV-102 0.7% in CIDME | Experimental | INV-102 0.7% Ophthalmic Solution given three times daily (TID) for 2 weeks followed by twice daily (BID) for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INV-102 | Drug | 0.7% Ophthalmic Solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in macular volume | Measured using spectral domain optical coherence tomography (SD-OCT) | 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Shalwitz | Invirsa, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedTrials, Inc. | Dallas | Texas | 75204 | United States |
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| 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 | Day 84 (Part 1) and Day 56 (Part 2) |
| Change in best corrected visual acuity (BCVA) (Part 2 only) | Day 56 |
| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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