About this trial
This study will assess corneal endothelial cells in participants with nAMD treated with PDS refilled every 24 weeks (Q24W).
Eligibility criteria
Qualifiers
Diagnosis of nAMD prior to screening as determined by the investigator
Difference of <10% in ECD at screening between the 2 eyes as measured by specular microscopy and determined by the independent reading center
Availability of historical visual acuity (VA) data and spectral-domain optical coherence tomography (SD-OCT). Additionally, fluorescein angiography or color fundus photography can both be used to support participant eligibility per protocol at investigator discretion
Availability of comprehensive historical anti-vascular endothelial growth factor (VEGF) injection data, including agent administered and date of administration from the time of diagnosis, or for at least 2 years prior to screening if diagnosis was made more than 2 years before screening
Disqualifiers
Prior treatment with external-beam radiation therapy or transpupillary thermotherapy
Previous treatment with verteporfin injection (PDT) or corticosteroid IVT injection within 2 years of screening
Previous laser (except PDT as stated above) used for age related macular degeneration (AMD) treatment
History of corneal transplant
Trial design
Treatments tested in this trial
- PDS Implant With Ranibizumab 100 mg/ml
- LUCENTIS (Ranibizumab Injection)