Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age- Related Macular Degeneration

Description

Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects with Neovascular Age- Related Macular Degeneration

Conditions

Neovascular Age-related Macular Degeneration

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Study Overview

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Study Details

Study overview

Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects with Neovascular Age- Related Macular Degeneration

A Phase 3, Multicenter, Double-Masked, Randomized, Parallel Group Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age- Related Macular Degeneration

Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age- Related Macular Degeneration

Condition
Neovascular Age-related Macular Degeneration
Intervention / Treatment

-

Contacts and Locations

Saint Petersburg

Retina Vitreous Associates of Florida- Saint Petersburg, Saint Petersburg, Florida, United States, 33711

Hagerstown

Cumberland Valley Retina Consultants, Hagerstown, Maryland, United States, 21740

Reno

Sierra Eye Associates, Reno, Nevada, United States, 89502

Bloomfield

The Retina Center Of New Jersey, LLC - Bloomfield, Bloomfield, New Jersey, United States, 07003

Erie

Erie Retina Research, Erie, Pennsylvania, United States, 16507

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Treatment naïve juxtafoveal and/or SFNV secondary to Neovascular Age- Related Macular Degeneration (nAMD) with leakage involving the fovea in the study eye prior to Screening, or have a diagnosis of Neovascular Age- Related Macular Degeneration (nAMD) in study eye within 3 months prior to screening and received up to 2 monthly injections of 2 mg aflibercept with last injection approximately 4 weeks prior to Screening
  • * Have provided written consent
  • * Monocular subject or Best Corrected Visual Acuity (BCVA) score of \<20 ETDRS letters or 20/400 in fellow eye at Screening
  • * Have evidence of a scar, fibrosis, or atrophy of \>50% of the total lesion in the study eye.

Ages Eligible for Study

50 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ocular Therapeutix, Inc.,

Dilsher Dhoot, MD, PRINCIPAL_INVESTIGATOR, California Retina Consultants (CRC) - Santa Barbara

Study Record Dates

2027-01-08