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Study Evaluating the Treatment of OTX-TKI for Subjects With Neovascular Age-related Macular Degeneration

Sponsor
Ocular Therapeutix, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04989699
Collaborator
(none)
21
Enrollment
6
Locations
2
Arms
16.1
Anticipated Duration (Months)
3.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Evaluate the safety, tolerability, and efficacy of OTX-TKI for intravitreal use in subjects with Neovascular Age-Related Macular Degeneration

Condition or Disease Intervention/Treatment Phase
Phase 1

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

Study Design

Study Type:
Interventional
Actual Enrollment :
21 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
3:13:1
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Jul 28, 2021
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: OTX-TKI

Drug: OTX-TKI/Sham
OTX-TKI is one dose so subsequent visits will be sham to maintain the mask
Active Comparator: Aflibercept

Drug: Aflibercept/Sham
Aflibercept administered every 8 weeks
Other Names:
  • Eylea

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Best Corrected Visual Acuity (BCVA) change [Baseline to 28 weeks]

    Secondary Outcome Measures

    1. BCVA changes [Baseline through 36 weeks]

    2. Central subfield thickness changes [Baseline through 36 weeks]

    3. Rescue Therapy [Baseline through 36 weeks]

      Proportion of subjects receiving rescue therapy, mean time to rescue, mean number of rescue injections

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ocular Therapeutix Bakersfield California United States 93309
    2 Ocular Therapeutix Oxnard California United States 93036
    3 Ocular Therapeutix Altamonte Springs Florida United States 32701
    4 Ocular Therapeutix Saint Petersburg Florida United States 33711
    5 Ocular Therapeutix Reno Nevada United States 89502
    6 Ocular Therapeutix The Woodlands Texas United States 77384

    Sponsors and Collaborators

    • Ocular Therapeutix, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ocular Therapeutix, Inc.
    ClinicalTrials.gov Identifier:
    NCT04989699
    Other Study ID Numbers:
    • OTX-TKI-2020-101
    First Posted:
    Aug 4, 2021
    Last Update Posted:
    Feb 7, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Macular Degeneration
    Wet Macular Degeneration
    Aflibercept

    Study Results

    No Results Posted as of Feb 7, 2022