A Study Assessing Corneal Endothelial Cells in Participants With Neovascular Age-related Macular Degeneration (nAMD) Treated With the Port Delivery System With Ranibizumab (PDS)

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age50+
SponsorGenentech, Inc.

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)

Treatment groups

188 Participants
are divided into 1 treatment group

Sponsors and collaborators