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.

Tracking Information

• First Submitted Date: June 1, 2018
• First Posted Date: August 14, 2018
• Last Update Posted Date: June 1, 2020
• Actual Study Start Date: February 18, 2019
• Estimated Primary Completion Date: November 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 7, 2019)

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

Original Primary Outcome Measures (submitted: August 9, 2018)

Incidence of treatment emergent adverse events for each subject [ Time Frame: 12 months ]

All adverse events from screening through end of study will be captured

Current Secondary Outcome Measures (submitted: May 26, 2020)

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.

Original Secondary Outcome Measures (submitted: August 9, 2018)

Determine the Maximum Tolerated Dose of the OTX-TKI injection [ Time Frame: 12 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 in 3 cohorts. If all subjects tolerate the lower dosage in cohort 1, additional subjects will be treated at a higher dosage in cohort 2. All data will be evaluated by the DSMC who, in concert with the Medical Monitor, will determine the Maximally Tolerated Dose and treat an additional cohort of subjects in cohort 3 using the MTD OTX-TKI Injection.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: CLN-0046: Treatment of AMD Subjects With OTX-TKI
• 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)
• 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 Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Neovascular Age-related 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).
• Drug: Anti-VEGF
  Standard of care therapy used to block vascular endothelial growth factor
  Other Names:

  • aflibercept
  • bevacizumab
  • ranibizumab

Study Arms

• Experimental: Cohort 1 (Low Dose)
  Subjects will receive a low dose of OTX-TKI
  Intervention: Drug: OTX-TKI
• Experimental: Cohort 2 (Middle Dose)
  Subjects will receive a middle dose of OTX-TKI.
  Intervention: Drug: OTX-TKI
• Experimental: Cohort 3 (High Dose)
  Subjects will receive a high dose of OTX-TKI.
  Intervention: Drug: OTX-TKI
• Experimental: Cohort 3 (Anti-VEGF)
  Subjects will receive OTX-TKI plus a single anti-VEGF injection
  Interventions:

  • Drug: OTX-TKI
  • Drug: Anti-VEGF

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 26, 2020): 26
• Original Estimated Enrollment (submitted: August 9, 2018): 25
• Estimated Study Completion Date: November 2021
• Estimated Primary Completion Date: November 2021 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years to 100 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: Australia

Administrative Information

• NCT Number: NCT03630315
• Other Study ID Numbers: CLN-0046
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

• IPD Sharing Statement: Not Provided
• Responsible Party: Ocular Therapeutix, Inc.
• Study Sponsor: Ocular Therapeutix, Inc.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Ocular Therapeutix, Inc.
• Verification Date: May 2020