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

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

Tracking Information
First Submitted Date  ICMJE June 1, 2018
First Posted Date  ICMJE August 14, 2018
Last Update Posted Date June 1, 2020
Actual Study Start Date  ICMJE February 18, 2019
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE CLN-0046: Treatment of AMD Subjects With OTX-TKI
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neovascular Age-related Macular Degeneration
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 26, 2020)
26
Original Estimated Enrollment  ICMJE
 (submitted: August 9, 2018)
25
Estimated Study Completion Date  ICMJE November 2021
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Clinical Project Manager 1-781-357-4000 clinicalaffairs@ocutx.com
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03630315
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Responsible Party Ocular Therapeutix, Inc.
Study Sponsor  ICMJE Ocular Therapeutix, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ocular Therapeutix, Inc.
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP