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

Ocular Therapeutix, Inc.2 sites in 1 country29 target enrollmentFebruary 18, 2019

ConditionsNeovascular Age-related Macular Degeneration

InterventionsOTX-TKI Anti-VEGF

DrugsOTX-TKI Anti-VEGF

Overview

Phase: Phase 1
Intervention: OTX-TKI
Conditions: Neovascular Age-related Macular Degeneration
Sponsor: Ocular Therapeutix, Inc.
Enrollment: 29
Locations: 2
Primary Endpoint: Incidence of treatment emergent adverse events for each subject
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

February 18, 2019

End Date

January 10, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Ocular Therapeutix, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Are at least 50 years of age
•Are eligible for standard therapy
•Have active primary CNVM secondary to AMD, either newly diagnosed or previously treated with documented response to anti-VEGF therapy in the study eye \[primary subfoveal CNV secondary to AMD including juxtafoveal lesions that affect the fovea\] documented by FA and SD-OCT
•Are female who is postmenopausal for at least 12 months prior to screening or surgically sterile; or male or female of childbearing potential willing to use two forms of adequate contraception
•Are able and willing to comply with all study requirements and visits

Exclusion Criteria

•Have previous laser photocoagulation to the center of the fovea in the study eye
•Have participated in any study involving an investigational drug either in the U.S. or outside the U.S. within the past 30 days
•Are an employee of the site that is directly involved in the management, administration, or support of the study, or be an immediate family member of the same
•Have a presence of a disease other than CNVM due to AMD in the study eye that could affect vision or safety assessments