The purpose of this Phase 1 study is comprised of multiple ascending-dose component (Part 1) and high concentration component (Part 2) to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AM712 in patients with neovascular age- related macular degeneration (nAMD).
The Part 1 of study is a multicenter, open-label, sequentially, multiple ascending-dose study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AM712 in subjects with nAMD. Subjects will be sequentially enrolled into different dose-level cohorts following the traditional "3+3" design until the maximally tolerated dose (MTD) or the maximally administered dose (MAD) has been reached. The Part 2 of study is a multicenter, open-label, sequential study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AM712 in treatment-naïve patients with nAMD.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
AM712 is a recombinant anti-VEGF humanized monoclonal antibody and Ang-2 antagonist peptide fusion protein, which has high specificity for the binding of VEGF-A and Ang-2.
Retina Consultants San Diego
Poway, California, United States
Bay Area Retina Associates
Walnut Creek, California, United States
Colorado Retina
Lakewood, Colorado, United States
Florida Eye Associates
Incidence of ocular adverse events (AEs) of the study eyes
To evaluate the safety and tolerability of AM712 in Subjects with neovascular Age-related Macular Degeneration (nAMD)
Time frame: 252 days
Incidence of non-ocular AEs
To evaluate the safety and tolerability of AM712 in Subjects with neovascular Age-related Macular Degeneration (nAMD)
Time frame: 252 days
Any relevant safety observations derived from BCVA
To evaluate the safety and tolerability of AM712 in Subjects with neovascular Age-related Macular Degeneration (nAMD)
Time frame: 252 days
Any relevant safety observations derived from SD-OCT
To evaluate the safety and tolerability of AM712 in Subjects with neovascular Age-related Macular Degeneration (nAMD)
Time frame: 252 days
Mean change from baseline in central subfield thickness as assessed by SD-OCT
To evaluate the efficacy of AM712 in Subjects with nAMD
Time frame: 252 days
Proportion of patients with no intraretinal fluid, subretinal fluid, or pigment epithelial detachment as assessed by SD-OCT
To evaluate the efficacy of AM712 in Subjects with nAMD
Time frame: 252 days
Mean change from baseline in BCVA (ETDRS)
To evaluate the efficacy of AM712 in Subjects with nAMD
Time frame: 252 days
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Melbourne, Florida, United States
Retina Research Institute at New England Retina Consultants
Springfield, Massachusetts, United States
Tennessee Retina, PC
Nashville, Tennessee, United States
Retina Consultants of Texas
Bellaire, Texas, United States
Retina Consultants of Texas
San Antonio, Texas, United States
Retina Consultants of Texas
The Woodlands, Texas, United States
Proportion of patients gaining ≥ 15 letters from baseline BCVA
To evaluate the efficacy of AM712 in Subjects with nAMD
Time frame: 252 days