The purpose of this study is to assess the safety, tolerability, bioactivity and pharmacokinetics of three concentrations of DE-120 after a single intravitreal injection in subjects with late stage exudative age-related macular degeneration.
This is an open-label, dose-escalating, sequential-cohort study of DE-120 injectable solution administered in 9, and up to 12, subjects with late stage exudative age-related macular degeneration. Three cohorts of 3 subjects will receive a single intravitreal injection in the study eye. Subjects in Cohort 1 will receive a single intravitreal injection of Low Dose DE-120 injectable solution in the study eye and will be evaluated through Visit 5 (Month 1). If the Low Dose is considered to be safe, the next higher dose will be administered to Cohort 2. The same enrollment and safety review procedures will be followed for Cohort 2 (Medium Dose DE-120) and Cohort 3 (High Dose DE-120).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Unnamed facility
Bakersfield, California, United States
Unnamed facility
Beverly Hills, California, United States
Unnamed facility
Dallas, Texas, United States
Number of subjects with adverse events
Adverse events will be assessed at each visit to assess safety
Time frame: Each visit from Day 1 to Study Exit (Month 24)
Change from Baseline in central subfield thickness (CST)
CST will be measured using spectral domain optical coherence tomography (SD-OCT)
Time frame: Each visit from Day 1 through Study Exit (Month 24)
Change from Baseline in macular volume
Macular volume will be measured using spectral domain optical coherence tomography (SD-OCT)
Time frame: Each visit from Day 1 through Study Exit (Month 24)
Drug concentration in plasma over time after a single injection of DE-120
Pharmacokinetic assessments will include area under the plasma concentration time curve (AUC), peak plasma concentration (Cmax), time to peak plasma concentration (tmax) and elimination half life (t1/2)
Time frame: Most visits from Day 1 through Study Exit (Month 24)
Change from Baseline in ocular signs and symptoms
Ocular signs and ocular symptoms will be collected at each visit using slit lamp biomicroscopy, corrected visual acuity, ophthalmoscopy and intraocular pressure measurements
Time frame: Each visit from Day 1 through Study Exit (Month 24)
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