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

January 25, 2024 updated by: Ocular Therapeutix, Inc.

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Bakersfield, California, United States, 93309
        • Ocular Therapeutix
      • Oxnard, California, United States, 93036
        • Ocular Therapeutix
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • Ocular Therapeutix
      • Saint Petersburg, Florida, United States, 33711
        • Ocular Therapeutix
    • Nevada
      • Reno, Nevada, United States, 89502
        • Ocular Therapeutix
    • Texas
      • The Woodlands, Texas, United States, 77384
        • Ocular Therapeutix

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Aflibercept
Drug: Aflibercept/Sham
Aflibercept administered every 8 weeks
Other Names:
  • Eylea
Active Comparator: OTX-TKI
Drug: OTX-TKI/Sham
OTX-TKI is one dose so subsequent visits will be sham to maintain the mask

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Tolerability
Time Frame: Through study completion, an average of 1 year
Incidence and severity of treatment emergent adverse events
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BCVA changes
Time Frame: Through study completion, an average of 1 year
BCVA Changes from Baseline
Through study completion, an average of 1 year
Central subfield thickness changes
Time Frame: Through study completion, an average of 1 year
Central subfield thickness changes from baseline
Through study completion, an average of 1 year
Rescue Therapy
Time Frame: Through study completion, an average of 1 year
Proportion of subjects receiving rescue therapy
Through study completion, an average of 1 year
Absence of Fluid
Time Frame: Through study completion, an average of 1 year
Proportion of subjects with absence of foveal fluid
Through study completion, an average of 1 year
Number of injections
Time Frame: Through study completion, an average of 1 year
Number of injections from baseline
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ocular Therapeutix, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 28, 2021

Primary Completion (Actual)

February 6, 2023

Study Completion (Actual)

December 18, 2023

Study Registration Dates

First Submitted

July 2, 2021

First Submitted That Met QC Criteria

August 3, 2021

First Posted (Actual)

August 4, 2021

Study Record Updates

Last Update Posted (Estimated)

January 26, 2024

Last Update Submitted That Met QC Criteria

January 25, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OTX-TKI-2020-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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