Neovascular Age-related Macular Degeneration
Conditions
Keywords
Neovascular Age-Related Macular Degeneration, Tyrosine Kinase Inhibitor, OTX-TKI
Brief summary
Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects with Neovascular Age- Related Macular Degeneration
Interventions
DRUGOTX-TKI
Intravitreal Injection of OTX-TKI
DRUGAflibercept
Intravitreal Injection of 2mg of aflibercept
Sponsors
Fortrea
Duke University
Ocular Therapeutix, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best Corrected Visual Acuity (BCVA) | Week 48 | Mean change in Best Corrected Visual Acuity (BCVA) from baseline at Week 48 |
Countries
Argentina, Australia, Puerto Rico, United States
Outcome results
None listed