Title
A Phase 1, Open-Label Study of Teprotumumab in Patients With Diabetic Macular Edema (DME)
Phase 1, Open-Label Safety and Pharmacodynamic Study of RV001, an Insulin-Like Growth Factor-1 Receptor (IGF-1R) Antagonist, Administered by Intravenous (IV) Infusion in Patients With Diabetic Macular Edema (DME)
Phase
Phase 1Lead Sponsor
River Vision Development CorporationStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Diabetic Macular EdemaIntervention/Treatment
teprotumumab ...Study Participants
5A Phase 1 Study to evaluate the Safety of teprotumumab in Patients with Diabetic Macular Edema.
A Phase 1, Open-Label Safety and Pharmacodynamic Study of RV 001, an Insulin-Like Growth Factor-1 Receptor (IGF-1) Antagonist, Given By IV Infusion in Patients with Diabetic Macular Edema (DME).
Teprotumumab 20mg/kg administered by intravenous infusion every 3 weeks for 3 infusions
Teprotumumab 20mg/kg administered by intravenous infusion every 3 weeks for 3 infusions
Inclusion Criteria: Diagnosis of diabetes mellitus with Hemoglobin A1c <8.5% IGF 1 in serum > 106 ng/mL Women of child-bearing potential must have negative pregnancy test and be willing and able to use two different methods of contraception, one of which must be oral contraceptive or depot formulation. Males must be surgically sterile or agree to use barrier contraception Clinically significant DME of less than 12 months duration Non-proliferative diabetic retinopathy of moderate severity Best corrected electronic ETDRS letter score < 78 and > 24 Exclusion Criteria: Unstable-uncontrolled diabetes as demonstrated by a change in diabetes medication greater than 15% in the previous 60 days. Significant renal disease, myocardial infarction, stroke, transient ischemic attack, acute congestive heart failure Blood pressure > 180/110 Anti-vascular endothelial growth factor (VEGF) treatment within two months prior to enrollment History of pan retinal photocoagulation within four months prior to enrollment History of ocular surgery within four months prior to enrollment History of systemic treatment with corticosteroids within 3 months prior to enrollment
