The purpose of this study is to test DS-7080a, a monoclonal antibody, as a new treatment for neovascular age-related macular degeneration (AMD) and diabetic macular edema (DME). The hypothesis of the study is that DS-7080a is safe and shows preliminary efficacy in patients with these conditions either alone or in combination with ranibizumab. This study is organized into 3 Parts: Part 1 Dose Escalation in AMD participants, Part 2 Dose Expansion in AMD participants, and Part 3 Dose Expansion in DME participants. In Part 1, participants will be enrolled into 3 sequential, ascending dose-level cohorts in non-randomized uncontrolled manner with the main purpose to determine the recommended dose. In Part 2, participants will be randomized to 1 of 3 arms of either monotherapy with DS-7080a or monotherapy with ranibizumab, which is an active control, or combination therapy of DS-7080a plus ranibizumab (ranibizumab will be administered 30 minutes prior to DS-7080a). In Part 3, subjects with DME will be assigned to 1 of 2 arms of either monotherapy with DS-7080a or monotherapy with ranibizumab. DS-7080a or ranibizumab will be administered 3 times: on Baseline/Day 1, Day 29, and Day 57. Both Parts 2 and 3 will consist of 8 visits including a 14-day screening phase, an 84-day treatment period, and a 28-day follow-up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
1.0, 2.0, or 4.0 mg administered by a 50 μL intravitreal (IVT) injection of solution
0.3 mg or 0.5 mg administered by a 50 μL IVT injection of solution
Unnamed facility
Phoenix, Arizona, United States
Unnamed facility
Arcadia, California, United States
Unnamed facility
Beverly Hills, California, United States
Unnamed facility
Palm Desert, California, United States
Unnamed facility
Fort Myers, Florida, United States
Unnamed facility
Baltimore, Maryland, United States
Unnamed facility
Boston, Massachusetts, United States
Unnamed facility
Omaha, Nebraska, United States
Unnamed facility
Abilene, Texas, United States
Unnamed facility
Austin, Texas, United States
...and 2 more locations
Number of participants experiencing any treatment-emergent adverse event (TEAE)
Treatment-emergent AEs (TEAEs) are defined as those adverse events (AEs) that were new or got worse between the start of study treatment and the end of the follow-up period.
Time frame: 16 weeks
Best Corrected Visual Acuity (BCVA) score
Visual acuity of both eyes will be assessed at all study visits using the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score. The patient starts are the top of the chart and begins to read down the chart. The patient reads down the chart until he or she reaches a row where a minimum of three letters on a line cannot be read. The patient is scored by how many letters could be correctly identified. Added to the score for the last row where the participant could read all five letters correctly are scores for each additional letter that could be read correctly in the next row. This is the BCVA score. A higher score means better visual acuity (sharpness of vision).
Time frame: 12 weeks
Change from baseline in retinal thickness and volume
Retinal thickness and volume are assessed by spectral domain optical coherence tomography (SD-OCT)
Time frame: 12 weeks
Change from baseline in retinal leakage
Retinal leakage is assessed by fluorescein angiography (FA)
Time frame: 12 weeks
Plasma concentrations
Concentration of study drug in blood plasma
Time frame: 12 weeks
Part 3 only: Change from baseline in vessel flow density, foveal avascular zone (FAZ) area, and FAZ shape
Vessel flow density, foveal avascular zone (FAZ) area, and FAZ shape are assessed by OCT angiography (OCT-A)
Time frame: 12 weeks
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