Study Evaluating the Treatment of OTX-TKI for Subjects With Neovascular Age-related Macular Degeneration
Primary Purpose
Neovascular Age-Related Macular Degeneration
Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
OTX-TKI/Sham
Aflibercept/Sham
Sponsored by
About this trial
This is an interventional treatment trial for Neovascular Age-Related Macular Degeneration
Eligibility Criteria
Inclusion Criteria:
- Have a diagnosis, within 3 years of screening, of previously treated subfoveal neovascularization (SFNV) secondary to nAMD with leakage involving the fovea, previously treated with documented evidence of an initially favorable clinical response to anti-VEGF therapy (i.e. aflibercept, ranibizumab, brolucizumab, or bevacizumab).
- The macular appearance on OCT is considered to be free of excess intraretinal and/or subretinal fluid as judged by the investigator.
- Must have received at least 3 anti-VEGF injections in the past year.
- Have received the most recent anti-VEGF injection within the past 1-4 weeks prior to screening visit.
- BCVA ETDRS score between 24 and 83 letters (~20/25 to ~20/320 Snellen equivalent)
Exclusion Criteria:
- Have evidence of a scar, fibrosis or atrophy of >50% of the total lesion in the study eye
- Have presence of a disease other than choroidal neovascular membrane (CNVM) due to AMD in the study eye that could affect vision or safety assessments
- Have monocular vision (fellow eye Snellen BCVA is 20/200 or worse
Sites / Locations
- Ocular Therapeutix
- Ocular Therapeutix
- Ocular Therapeutix
- Ocular Therapeutix
- Ocular Therapeutix
- Ocular Therapeutix
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
OTX-TKI
Aflibercept
Arm Description
Outcomes
Primary Outcome Measures
Safety and Tolerability
Incidence and severity of treatment emergent adverse events
Secondary Outcome Measures
BCVA changes
BCVA Changes from Baseline
Central subfield thickness changes
Central subfield thickness changes from baseline
Rescue Therapy
Proportion of subjects receiving rescue therapy
Absence of Fluid
Proportion of subjects with absence of foveal fluid
Number of injections
Number of injections from baseline
Full Information
NCT ID
NCT04989699
First Posted
July 2, 2021
Last Updated
September 1, 2022
Sponsor
Ocular Therapeutix, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04989699
Brief Title
Study Evaluating the Treatment of OTX-TKI for Subjects With Neovascular Age-related Macular Degeneration
Official Title
A Prospective Multicenter, Double-Masked, Randomized, Parallel-Group, Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-TKI (Axitinib Implant) for Intravitreal Use in Subjects With Neovascular Age-Related Macular Degeneration (nAMD)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 28, 2021 (Actual)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
February 2023 (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
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluate the safety, tolerability, and efficacy of OTX-TKI for intravitreal use in subjects with Neovascular Age-Related Macular Degeneration
Detailed Description
Multicenter, double masked, randomized, parallel-group study to evaluate the safety, tolerability, and efficacy of OTX-TKI for intravitreal use in subjects with Neovascular Age-Related Macular Degeneration
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
Parallel Assignment
Model Description
3:1
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OTX-TKI
Arm Type
Active Comparator
Arm Title
Aflibercept
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
OTX-TKI/Sham
Intervention Description
OTX-TKI is one dose so subsequent visits will be sham to maintain the mask
Intervention Type
Drug
Intervention Name(s)
Aflibercept/Sham
Other Intervention Name(s)
Eylea
Intervention Description
Aflibercept administered every 8 weeks
Primary Outcome Measure Information:
Title
Safety and Tolerability
Description
Incidence and severity of treatment emergent adverse events
Time Frame
Through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
BCVA changes
Description
BCVA Changes from Baseline
Time Frame
Through study completion, an average of 1 year
Title
Central subfield thickness changes
Description
Central subfield thickness changes from baseline
Time Frame
Through study completion, an average of 1 year
Title
Rescue Therapy
Description
Proportion of subjects receiving rescue therapy
Time Frame
Through study completion, an average of 1 year
Title
Absence of Fluid
Description
Proportion of subjects with absence of foveal fluid
Time Frame
Through study completion, an average of 1 year
Title
Number of injections
Description
Number of injections from baseline
Time Frame
Through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have a diagnosis, within 3 years of screening, of previously treated subfoveal neovascularization (SFNV) secondary to nAMD with leakage involving the fovea, previously treated with documented evidence of an initially favorable clinical response to anti-VEGF therapy (i.e. aflibercept, ranibizumab, brolucizumab, or bevacizumab).
The macular appearance on OCT is considered to be free of excess intraretinal and/or subretinal fluid as judged by the investigator.
Must have received at least 3 anti-VEGF injections in the past year.
Have received the most recent anti-VEGF injection within the past 1-4 weeks prior to screening visit.
BCVA ETDRS score between 24 and 83 letters (~20/25 to ~20/320 Snellen equivalent)
Exclusion Criteria:
Have evidence of a scar, fibrosis or atrophy of >50% of the total lesion in the study eye
Have presence of a disease other than choroidal neovascular membrane (CNVM) due to AMD in the study eye that could affect vision or safety assessments
Have monocular vision (fellow eye Snellen BCVA is 20/200 or worse
Facility Information:
Facility Name
Ocular Therapeutix
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Ocular Therapeutix
City
Oxnard
State/Province
California
ZIP/Postal Code
93036
Country
United States
Facility Name
Ocular Therapeutix
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
Ocular Therapeutix
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33711
Country
United States
Facility Name
Ocular Therapeutix
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Ocular Therapeutix
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating the Treatment of OTX-TKI for Subjects With Neovascular Age-related Macular Degeneration
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