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

Phase 1

Completed

• Conditions: Neovascular Age-related Macular Degeneration
• Interventions: Drug: OTX-TKI; Drug: Anti-VEGF

• Registration Number: NCT03630315
• Lead Sponsor: Ocular Therapeutix, Inc.

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.

Study Timeline

• Study First Submitted: 2018-06-01
• Study First Submitted QC: 2018-08-09
• Study First Posted: 2018-08-14
• Study Start: 2019-02-18
• Primary Completion: 2024-01-10
• Study Completion: 2024-01-10
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 1 (Low Dose)	OTX-TKI	Subjects will receive a low dose of OTX-TKI
Cohort 2 (Middle Dose)	OTX-TKI	Subjects will receive a middle dose of OTX-TKI.
Cohort 3 (Anti-VEGF)	Anti-VEGF	Subjects will receive OTX-TKI plus a single anti-VEGF injection
Cohort 4 (High Dose)	OTX-TKI	Subjects will receive a high dose of OTX-TKI.
Cohort 4 (Anti-VEGF)	OTX-TKI	Subjects will receive OTX-TKI plus a single anti-VEGF injection
Cohort 4 (Anti-VEGF)	Anti-VEGF	Subjects will receive OTX-TKI plus a single anti-VEGF injection
Cohort 3 (High Dose)	OTX-TKI	Subjects will receive a high dose of OTX-TKI.
Cohort 3 (Anti-VEGF)	OTX-TKI	Subjects will receive OTX-TKI plus a single anti-VEGF injection

Primary Outcome Measures

Name	Time	Method
Incidence of treatment emergent adverse events for each subject	9 months	All adverse events from screening through end of study will be captured

Secondary Outcome Measures

Name	Time	Method
Determine the Maximum Tolerated Dose of the OTX-TKI injection	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.

Trial Locations

Locations (2)

Ocular Therapeutix, Inc.; 🇦🇺 Melbourne, Australia

Ocular Therapeutiux, Inc.; 🇦🇺 Sydney, Site 3, Australia