Phase 1/2 Amendment 1Clinical Study Protocol • May 26th, 2018
Contract Type FiledMay 26th, 2018Abbreviation Expression (Name) in full AE(s) adverse event(s) ALP alkaline phosphatase ALT alanine transaminase AMD age-related macular degeneration AST aspartate aminotransferase BCVA best corrected visual acuity BUN blood urea nitrogen CNV choroidal neo-vascularization CRF Case report form CST central subfield thickness dL deciliter eCRF(s) Electronic Case Report Form(s) EDC EC Electronic Data Capture Ethics Committee EKG electrocardiogram (= ECG) ESI(s) event(s) of special interest ETDRS Early Treatment of Diabetic Retinopathy Study FDA Food and Drug Administration FGF fibroblast growth factor GCP Good Clinical Practice GGT gamma-glutamyl transpeptidase GMPGLP Good Manufacturing PracticeGood Laboratory Practice hCG human chorionic gonadotropin HCT hematocrit HDL high density lipoprotein HGB hemoglobin HIPAA Health Insurance Portability and Accountability Act of 1996 ICF informed consent form ICH International Conference on Harmonization IEC Independent Ethics Committee IND Investiga