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Study Evaluating the Treatment of OTX-TKI for Subjects With Neovascular Age-related Macular Degeneration | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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)

NCT04989699•Ocular Therapeutix, Inc.

View on ClinicalTrials.gov

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

Eligibility

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (6)

Ocular Therapeutix

Bakersfield, California, United States

Ocular Therapeutix

Oxnard, California, United States

Ocular Therapeutix

Altamonte Springs, Florida, United States

Ocular Therapeutix

St. Petersburg, Florida, United States

Ocular Therapeutix

Reno, Nevada, United States

Ocular Therapeutix

The Woodlands, Texas, United States

Key Dates

Start Date

July 28, 2021

Primary Completion Date

February 6, 2023

Completion Date

December 18, 2023

Last Updated

January 26, 2024

Enrollment

ACTUAL participants

Conditions

Neovascular Age-Related Macular Degeneration

Interventions

OTX-TKI/Sham

DRUG

Aflibercept/Sham

DRUG

A Study of the Efficacy, Safety, and Pharmacokinetics (PK) of the Port Delivery System With Ranibizumab (PDS) in Chinese Participants With Neovascular Age-related Macular Degeneration (nAMD)

NCT05562947

Neovascular Age-related Macular DegenerationnAMD

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RECRUITINGPHASE3

Home OCT-Guided Treatment Versus Treat and Extend for the Management of Neovascular AMD

NCT05904028

Neovascular Age-related Macular Degeneration

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 26, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of the Efficacy, Safety, and Pharmacokinetics (PK) of the Port Delivery System With Ranibizumab (PDS) in Chinese Participants With Neovascular Age-related Macular Degeneration (nAMD)

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