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

NCT ID: NCT03630315

Last Updated: 2024-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-18
• Study Completion Date: 2024-01-10

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.

Conditions

Neovascular Age-related Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1 (Low Dose)

Subjects will receive a low dose of OTX-TKI

Group Type: EXPERIMENTAL

OTX-TKI

Intervention Type: DRUG

OTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI).

Cohort 2 (Middle Dose)

Subjects will receive a middle dose of OTX-TKI.

Group Type: EXPERIMENTAL

OTX-TKI

Intervention Type: DRUG

OTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI).

Cohort 3 (High Dose)

Subjects will receive a high dose of OTX-TKI.

Group Type: EXPERIMENTAL

OTX-TKI

Intervention Type: DRUG

OTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI).

Cohort 3 (Anti-VEGF)

Subjects will receive OTX-TKI plus a single anti-VEGF injection

Group Type: EXPERIMENTAL

OTX-TKI

Intervention Type: DRUG

OTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI).

Anti-VEGF

Intervention Type: DRUG

Standard of care therapy used to block vascular endothelial growth factor

Cohort 4 (High Dose)

Subjects will receive a high dose of OTX-TKI.

Group Type: EXPERIMENTAL

OTX-TKI

Intervention Type: DRUG

OTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI).

Cohort 4 (Anti-VEGF)

Subjects will receive OTX-TKI plus a single anti-VEGF injection

Group Type: EXPERIMENTAL

OTX-TKI

Intervention Type: DRUG

OTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI).

Anti-VEGF

Intervention Type: DRUG

Standard of care therapy used to block vascular endothelial growth factor

Interventions

OTX-TKI

OTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI).

Intervention Type: DRUG

OTX-TKI

OTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI).

Intervention Type: DRUG

OTX-TKI

OTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI).

Intervention Type: DRUG

OTX-TKI

OTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI).

Intervention Type: DRUG

Anti-VEGF

Standard of care therapy used to block vascular endothelial growth factor

Intervention Type: DRUG

OTX-TKI

OTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI).

Intervention Type: DRUG

Anti-VEGF

Standard of care therapy used to block vascular endothelial growth factor

Intervention Type: DRUG

Other Intervention Names

aflibercept; bevacizumab; ranibizumab; aflibercept; bevacizumab; ranibizumab

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ocular Therapeutix, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Ocular Therapeutix, Inc.

Albury, , Australia

Ocular Therapeutix, Inc.

Melbourne, , Australia

Countries

Australia

Other Identifiers

CLN-0046

Identifier Type: -

Identifier Source: org_study_id