Health Condition 1: H00-H59- Diseases of the eye and adnexa
Conditions
Interventions
Intervention1: OTX-TKI: Axitinib Intravitreal (ophthalmic) Implant to be used every 6 months
Control Intervention1: Eylea: Eylea 2 mg intravitreal (ophthalmic) injection given every month
Sponsors
Ocular Therapeutix, Inc.
PFC Pharma Focus India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Subjects with a diagnosis of active macular choroidal neovascularization (MNV) secondary to nAMD, who are at least 50 years of age, whose study eye either is treatment naive, or was diagnosed with nAMD within 4 months prior to screening and received 1 to 3 consecutive monthly (approximately every 4 weeks) anti-VEGF injections (except Beovu®) prior to Screening
Exclusion criteria
Exclusion criteria: Presence of a disease other than CNV due to AMD in the study eye that could affect vision or safety assessments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in best corrected visual acuity (BCVA)Timepoint: Change from baseline to Week 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in letters on ETDRS at Week 48Timepoint: Week 48 | — |
Countries
Argentina, Australia, Czech Republic, Finland, Germany, Hungary, India, Italy, Poland, Spain, United States of America
Contacts
Public ContactDr Saurendra Das
PFC Pharma Focus India Pvt Ltd
Outcome results
None listed