Evaluate the safety, tolerability, and efficacy of OTX-TKI for intravitreal use in subjects with Neovascular Age-Related Macular Degeneration
Multicenter, double masked, randomized, parallel-group study to evaluate the safety, tolerability, and efficacy of OTX-TKI for intravitreal use in subjects with Neovascular Age-Related Macular Degeneration
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
21
OTX-TKI is one dose so subsequent visits will be sham to maintain the mask
Aflibercept administered every 8 weeks
Ocular Therapeutix
Bakersfield, California, United States
Ocular Therapeutix
Oxnard, California, United States
Ocular Therapeutix
Altamonte Springs, Florida, United States
Ocular Therapeutix
St. Petersburg, Florida, United States
Safety and Tolerability
Incidence and severity of treatment emergent adverse events
Time frame: Through study completion, an average of 1 year
BCVA changes
BCVA Changes from Baseline
Time frame: Through study completion, an average of 1 year
Central subfield thickness changes
Central subfield thickness changes from baseline
Time frame: Through study completion, an average of 1 year
Rescue Therapy
Proportion of subjects receiving rescue therapy
Time frame: Through study completion, an average of 1 year
Absence of Fluid
Proportion of subjects with absence of foveal fluid
Time frame: Through study completion, an average of 1 year
Number of injections
Number of injections from baseline
Time frame: Through study completion, an average of 1 year
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Ocular Therapeutix
Reno, Nevada, United States
Ocular Therapeutix
The Woodlands, Texas, United States