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The trial is taking place at:
M

Mid Atlantic Retina Specialists | Hagerstown, MD

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

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Ocular Therapeutix

Status and phase

Enrolling
Phase 3

Conditions

Neovascular Age-related Macular Degeneration

Treatments

Drug: OTX-TKI
Drug: Aflibercept

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT06495918
OTX-TKI-2023-AMD-303

Details and patient eligibility

About

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

Enrollment

825 estimated patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion 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

Exclusion criteria

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

825 participants in 3 patient groups

OTX-TKI Re-dose
Experimental group
Treatment:
Drug: OTX-TKI
Aflibercept 2mg on label
Active Comparator group
Treatment:
Drug: Aflibercept
Drug: Aflibercept
Aflibercept 8mg high dose
Other group
Treatment:
Drug: Aflibercept
Drug: Aflibercept

Trial contacts and locations

57

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Central trial contact

Clinical Project Manager; Nichole Wilkes

Data sourced from clinicaltrials.gov

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