To evaluate the safety, tolerability and efficacy of OTX-TKI for intravitreal use, in subjects who have neovascular age-related macular degeneration (AMD).
A multi-center, dose escalation, Phase 1, safety, tolerability and efficacy study to evaluate three dose groups of the OTX-TKI implant to treat subjects with a diagnosis of primary subfoveal neovascularization secondary to AMD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
29
OTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI).
OTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI).
OTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI).
Ocular Therapeutix, Inc.
Sydney, Site 1, Australia
Ocular Therapeutiux, Inc.
Sydney, Site 2, Australia
Ocular Therapeutiux, Inc.
Sydney, Site 3, Australia
Ocular Therapeutix, Inc.
Adelaide, Australia
Incidence of treatment emergent adverse events for each subject
All adverse events from screening through end of study will be captured
Time frame: 9 months
Determine the Maximum Tolerated Dose of the OTX-TKI injection
A Central Reading Center will evaluate multiple imaging modalities to confirm evidence of biological activity for subjects that have been treated with the OTX-TKI injection. If all subjects tolerate lower dosages, additional subjects will be treated at higher dosages. All data will be evaluated by the DSMC who, in concert with the Medical Monitor, will determine the Maximally Tolerated Dose.
Time frame: 9 months
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OTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI).
Standard of care therapy used to block vascular endothelial growth factor
OTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI).
Standard of care therapy used to block vascular endothelial growth factor
Ocular Therapeutix, Inc.
Albury, Australia
Ocular Therapeutix, Inc.
Melbourne, Australia