Safety, Tolerability and PK of Subcutaneous D-4517.2 in Subjects With Wet AMD or DME (NCT05387837) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Safety, Tolerability and PK of Subcutaneous D-4517.2 in Subjects With Wet AMD or DME
United States50 participantsStarted 2022-08-31
Plain-language summary
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of D-4517.2 After Subcutaneous Administration in subjects with Neovascular (wet) Age-Related Macular Degeneration (AMD) or subjects with Diabetic Macular Edema (DME)
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Willing and able to give informed consent, comply with all study procedures, and be likely to complete the study.
✓. Demonstrated response to prior anti-VEGF treatment as defined by one or more of the following and as assessed by the Investigator for Stages 1 and 1A and confirmed by the Central Reader for Stage 2:
✓. Complete resolution or partial reduction of foveal intra- and/or subretinal fluid ≥ 30% from initial diagnosis as measured by SD-OCT.
✓. Increase in BCVA ≥ 2 lines from initial diagnosis using Snellen scale.
✓. Female subjects may be enrolled if they are:
✓. Not pregnant, lactating, or breastfeeding
✓. Documented in medical records or subject self-reported to be surgically sterile or postmenopausal.
✓. Female subjects of childbearing potential must practice true abstinence for at least 28 days prior to investigational product (IP) administration until 30 days after the last IP administration and have a negative serum and urine pregnancy test at Screening and Baseline Day 1, respectively, or
Exclusion criteria
✕. History, within 6 months prior to Screening, of any of the following: myocardial infarction, any cardiac event requiring hospitalization, treatment for acute congestive heart failure, transient ischemic attack or stroke.
✕. Uncontrolled hypertension with systolic BP ≥160 mmHg and/or diastolic BP ≥100 mmHg (while subject at rest) at the Screening Visit. If the subject's initial reading exceeds these values, a second reading may be taken 30 minutes later on the same day. If the subject's BP is controlled by antihypertensive medication, the subject should be taking the same medication continuously for at least 30 days prior to Day 1.
✕. Currently untreated diabetes mellitus, uncontrolled diabetes mellitus defined as HbA1c \> 12%, or previously untreated subjects with diabetes mellitus who initiated oral or injectable anti-diabetic medication within 3 months prior to Day 1.
✕. Chronic renal disease requiring chronic hemodialysis or renal transplantation.
✕. Abnormal liver function, as defined by transaminase or total bilirubin 2 times above the upper limit of normal at the Screening Visit.
✕. Medical history of Wolff-Parkinson-White Syndrome, family history of long QT or planned initiation or currently on medication prolonging QT time during the trial.
✕. Known allergy to constituents of the study drug formulation, aflibercept, or clinically relevant hypersensitivity to fluorescein used by the subject during the study.