Back to resultsCLN-0046: Treatment of AMD Subjects With OTX-TKI
Primary Purpose
Neovascular Age-related Macular Degeneration
Status
Active
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
OTX-TKI
OTX-TKI
OTX-TKI
OTX-TKI
Anti-VEGF
OTX-TKI
Anti-VEGF
Sponsored by
About this trial
This is an interventional treatment trial for Neovascular Age-related Macular Degeneration
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
Sites / Locations
- Ocular Therapeutix, Inc.
- Ocular Therapeutiux, Inc.
- Ocular Therapeutiux, Inc.
- Ocular Therapeutix, Inc.
- Ocular Therapeutix, Inc.
- Ocular Therapeutix, Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Cohort 1 (Low Dose)
Cohort 2 (Middle Dose)
Cohort 3 (High Dose)
Cohort 3 (Anti-VEGF)
Cohort 4 (High Dose)
Cohort 4 (Anti-VEGF)
Arm Description
Subjects will receive a low dose of OTX-TKI
Subjects will receive a middle dose of OTX-TKI.
Subjects will receive a high dose of OTX-TKI.
Subjects will receive OTX-TKI plus a single anti-VEGF injection
Subjects will receive a high dose of OTX-TKI.
Subjects will receive OTX-TKI plus a single anti-VEGF injection
Outcomes
Primary Outcome Measures
Incidence of treatment emergent adverse events for each subject
All adverse events from screening through end of study will be captured
Secondary Outcome Measures
Determine the Maximum Tolerated Dose of the OTX-TKI injection
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03630315
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)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 18, 2019 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ocular Therapeutix, Inc.
4. Oversight
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
Data Monitoring Committee
Yes
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovascular Age-related Macular Degeneration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1 (Low Dose)
Arm Type
Experimental
Arm Description
Subjects will receive a low dose of OTX-TKI
Arm Title
Cohort 2 (Middle Dose)
Arm Type
Experimental
Arm Description
Subjects will receive a middle dose of OTX-TKI.
Arm Title
Cohort 3 (High Dose)
Arm Type
Experimental
Arm Description
Subjects will receive a high dose of OTX-TKI.
Arm Title
Cohort 3 (Anti-VEGF)
Arm Type
Experimental
Arm Description
Subjects will receive OTX-TKI plus a single anti-VEGF injection
Arm Title
Cohort 4 (High Dose)
Arm Type
Experimental
Arm Description
Subjects will receive a high dose of OTX-TKI.
Arm Title
Cohort 4 (Anti-VEGF)
Arm Type
Experimental
Arm Description
Subjects will receive OTX-TKI plus a single anti-VEGF injection
Intervention Type
Drug
Intervention Name(s)
OTX-TKI
Intervention Description
OTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI).
Intervention Type
Drug
Intervention Name(s)
OTX-TKI
Intervention Description
OTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI).
Intervention Type
Drug
Intervention Name(s)
OTX-TKI
Intervention Description
OTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI).
Intervention Type
Drug
Intervention Name(s)
OTX-TKI
Intervention Description
OTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI).
Intervention Type
Drug
Intervention Name(s)
Anti-VEGF
Other Intervention Name(s)
aflibercept, bevacizumab, ranibizumab
Intervention Description
Standard of care therapy used to block vascular endothelial growth factor
Intervention Type
Drug
Intervention Name(s)
OTX-TKI
Intervention Description
OTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI).
Intervention Type
Drug
Intervention Name(s)
Anti-VEGF
Other Intervention Name(s)
aflibercept, bevacizumab, ranibizumab
Intervention Description
Standard of care therapy used to block vascular endothelial growth factor
Primary Outcome Measure Information:
Title
Incidence of treatment emergent adverse events for each subject
Description
All adverse events from screening through end of study will be captured
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Determine the Maximum Tolerated Dose of the OTX-TKI injection
Description
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.
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Ocular Therapeutix, Inc.
City
Sydney
State/Province
Site 1
Country
Australia
Facility Name
Ocular Therapeutiux, Inc.
City
Sydney
State/Province
Site 2
Country
Australia
Facility Name
Ocular Therapeutiux, Inc.
City
Sydney
State/Province
Site 3
Country
Australia
Facility Name
Ocular Therapeutix, Inc.
City
Adelaide
Country
Australia
Facility Name
Ocular Therapeutix, Inc.
City
Albury
Country
Australia
Facility Name
Ocular Therapeutix, Inc.
City
Melbourne
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
CLN-0046: Treatment of AMD Subjects With OTX-TKI
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