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Completed

NCT Number: NCT04989699

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

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

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Key information

Conditions

Neovascular Age-related Macular Degeneration

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ocular Therapeutix, Bakersfield, California, United States

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OTX-TKI/Sham

Drug

OTX-TKI is one dose so subsequent visits will be sham to maintain the mask

Aflibercept/Sham

Drug

Aflibercept administered every 8 weeks

Other names: Eylea

Primary outcomes

  1. Safety and Tolerability

    Time frame: Through study completion, an average of 1 year

    Incidence and severity of treatment emergent adverse events

Secondary outcomes

  1. BCVA changes

    Time frame: Through study completion, an average of 1 year

    BCVA Changes from Baseline

  2. Central subfield thickness changes

    Time frame: Through study completion, an average of 1 year

    Central subfield thickness changes from baseline

  3. Rescue Therapy

    Time frame: Through study completion, an average of 1 year

    Proportion of subjects receiving rescue therapy

  4. Absence of Fluid

    Time frame: Through study completion, an average of 1 year

    Proportion of subjects with absence of foveal fluid

  5. Number of injections

    Time frame: Through study completion, an average of 1 year

    Number of injections from baseline

Sponsors and collaborators

Lead sponsor

Ocular Therapeutix, Inc.

Industry

Registry information

Official study 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)

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 4, 2021
Registry last updated
Jan 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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