Diabetic Macular Edema in Underrepresented Populations
Elevatum-ML43435 (Sponsor: Genetech)
2022-Present
Office: Teaneck
NCT Number: NCT05224102
This Phase 4 study is designed to investigate treatment response in treatment-naïve underrepresented patients with diabetic macular edema (DME) who are treated with faricimab. The study population will consist of participants ≥18 years of age who self-identify as Black/African American, Hispanic/Latino American, or Native American/Alaska Native/Native Hawaiian or other Pacific Islander.
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Diabetic Retinopathy
DR:EAM-OTT166-201 (Sponsor: Ocuterra)
2022-Present
Office: Teaneck
NCT Number: NCT05409235
This randomized, double-masked, vehicle controlled, phase 2 study will evaluate the safety and efficacy of OTT166 ophthalmic solution in participants with diabetic retinopathy and select an optimum dosing regimen for Phase 3 pivotal trials. Approximately 210 participants diagnosed with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) or mild proliferative diabetic retinopathy (PDR) and who are treatment naïve (ie, no prior anti-vascular endothelial growth factor [anti-VEGF] or laser [focal, grid, pan-retinal photocoagulation (PRP)] administered) and participants who do not have center-involved diabetic macular edema (CI-DME) will be randomized into the following groups:
OTT166 Cohort 1, OTT166 Cohort 2, Vehicle control Cohort 1, Vehicle control Cohort 2.
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