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

Neovascular Age-related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03630315
• Other study ID #: CLN-0046
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: February 18, 2019
• Est. completion date: December 2022

Study information

• Verified date: August 2022
• Source: Ocular Therapeutix, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 29
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration
• Wet Macular Degeneration

Intervention

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

Locations

Country	Name	City	State
Australia	Ocular Therapeutix, Inc.	Adelaide
Australia	Ocular Therapeutix, Inc.	Albury
Australia	Ocular Therapeutix, Inc.	Melbourne
Australia	Ocular Therapeutiux, Inc.	Sydney	Site 2
Australia	Ocular Therapeutiux, Inc.	Sydney	Site 3
Australia	Ocular Therapeutix, Inc.	Sydney	Site 1

Sponsors (1)

Lead Sponsor	Collaborator
Ocular Therapeutix, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment emergent adverse events for each subject	All adverse events from screening through end of study will be captured	9 months
Secondary	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.	9 months