Phase 2a Pilot, Open Label, Multicenter, Study of INV-102 Ophthalmic Solution in Subjects With Diabetic Macular Edema (DME) Associated With Non-proliferative Diabetic Retinopathy (NPDR)
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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 \[Part 2\].
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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
Locations
United States
Texas
MedTrials, Inc.
RECRUITING
Dallas
Contact Information
Primary
Invirsa Call Center
info@invirsa.com
614-334-1765
Time Frame
Start Date: 2024-09-07
Estimated Completion Date: 2025-08
Participants
Target number of participants: 24
Treatments
Experimental: Part 1: INV-102 0.7% in NCIDME
INV-102 0.7% Ophthalmic Solution given three times daily (TID) for 2 weeks followed by twice daily (BID) for 10 weeks
Experimental: Part 2: INV-102 0.7% in CIDME
INV-102 0.7% Ophthalmic Solution given three times daily (TID) for 2 weeks followed by twice daily (BID) for 6 weeks
Related Therapeutic Areas
Sponsors
Leads: Invirsa, Inc.