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

• ClinicalTrials.gov Identifier: NCT03630315
• Recruitment Status: Recruiting
• First Posted: August 14, 2018
• Last Update Posted: June 1, 2020
• Sponsor: Ocular Therapeutix, Inc.
• Information provided by (Responsible Party): Ocular Therapeutix, Inc.

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Neovascular Age-related Macular Degeneration	Drug: OTX-TKI; Drug: Anti-VEGF	Phase 1

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: February 18, 2019
• Estimated Primary Completion Date: November 2021
• Estimated Study Completion Date: November 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Cohort 1 (Low Dose); Subjects will receive a low dose of OTX-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).
Experimental: Cohort 2 (Middle Dose); Subjects will receive a middle dose of OTX-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).
Experimental: Cohort 3 (High Dose); Subjects will receive a high dose of OTX-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).
Experimental: Cohort 3 (Anti-VEGF); Subjects will receive OTX-TKI plus a single anti-VEGF injection	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; Other Names: aflibercept; bevacizumab; ranibizumab

Outcome Measures

Primary Outcome Measures :

1. Incidence of treatment emergent adverse events for each subject [ Time Frame: 9 months ]
   All adverse events from screening through end of study will be captured

Secondary Outcome Measures :

1. Determine the Maximum Tolerated Dose of the OTX-TKI injection [ Time Frame: 9 months ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 50 Years to 100 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Clinical Project Manager; 1-781-357-4000; clinicalaffairs@ocutx.com

Locations

Australia

Brisbane Site 1; Recruiting

Brisbane, Australia

Melbourne Site 1; Recruiting

Melbourne, Australia

Sydney Site 1; Recruiting

Sydney, Australia

Sydney Site 2; Recruiting

Sydney, Australia

Sydney Site 3; Recruiting

Sydney, Australia

Sponsors and Collaborators

Ocular Therapeutix, Inc.

More Information

• Responsible Party: Ocular Therapeutix, Inc.
• ClinicalTrials.gov Identifier: NCT03630315
• Other Study ID Numbers: CLN-0046
• First Posted: August 14, 2018
• Last Update Posted: June 1, 2020
• Last Verified: May 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Macular Degeneration; Wet Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Ranibizumab; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Physiological Effects of Drugs; Growth Inhibitors