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Trial record 1 of 1 for:    OTX-tki | Neovascular Age-related Macular Degeneration
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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.

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.

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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

Resource links provided by the National Library of Medicine


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




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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03630315


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

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

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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:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
Ranibizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors