NCT03630315

CLN-0046: Treatment of AMD Subjects With OTX-TKI

A Phase 1 Open-Label, Dose Escalation Study of OTX-TKI for Intravitreal Use in Subjects With Neovascular Age-Related Macular Degeneration (AMD)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Ocular Therapeutix, Inc. · Industry
• Sex: All
• Age: 50 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety, tolerability and efficacy of OTX-TKI for intravitreal use, in subjects who have neovascular age-related macular degeneration (AMD).

Detailed description

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.

Conditions

• Neovascular Age-related Macular Degeneration

Interventions

Type	Name	Description
DRUG	OTX-TKI	OTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI).
DRUG	OTX-TKI	OTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI).
DRUG	OTX-TKI	OTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI).
DRUG	OTX-TKI	OTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI).
DRUG	Anti-VEGF	Standard of care therapy used to block vascular endothelial growth factor
DRUG	OTX-TKI	OTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI).
DRUG	Anti-VEGF	Standard of care therapy used to block vascular endothelial growth factor

Timeline

• Start date: 2019-02-18
• Primary completion: 2024-01-10
• Completion: 2024-01-10
• First posted: 2018-08-14
• Last updated: 2024-07-10

Locations

6 sites across 1 country: Australia