Summary

Eligibility
for people ages 50 years and up (full criteria)
Location
at UCLA UCSD UCSF
Dates
study started
estimated completion

Description

Summary

This study will evaluate the long-term safety and tolerability of the Port Delivery System with ranibizumab (PDS) 100 mg/mL with refill-exchanges administered every 24 weeks (Q24W) or every 36 weeks (Q36W) for approximately 144 weeks in participants with neovascular age-related macular degeneration who have completed either Phase II Study GX28228 (Ladder), Phase III Study GR40548 (Archway) or Phase IIIb Study WR42221 (Velodrome).

Official Title

A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of the Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration (Portal)

Keywords

Neovascular Age-Related Macular Degeneration Macular Degeneration Wet Macular Degeneration Ranibizumab PDS Implant with Ranibizumab 100 mg/mL

Eligibility

You can join if…

Open to people ages 50 years and up

  • Previous enrollment in and completion of Study GX28228 (Ladder) or Study GR40548 (Archway), without early treatment or study discontinuation in either study OR Previous enrollment in Study WR42221 (Velodrome) and either not eligible to be randomized in Study WR42221 at Week 24 or completed the study (from the Q24W or Q36W arm)
  • Ability and willingness to undertake all scheduled visits and assessments
  • For women of childbearing potential: agreement to remain abstinent or use contraceptive measures

You CAN'T join if...

  • Pregnant or breastfeeding, or intending to become pregnant during the treatment period and for at least 28 days after the last intravitreal injection of ranibizumab or 1 year after the last Implant refill-exchange of ranibizumab
  • History of other ocular diseases that give reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab, that might affect interpretation of the results of the study or that renders the participant at high risk for treatment complications
  • History of other diseases, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab or placement of the Implant and that might affect interpretation of the results of the study or that renders the participant at high risk of treatment complications
  • Requirement for continuous use of any medications or treatments indicated in the "Prohibited Therapy"

Locations

  • Jacobs Retina center at the Shiley eye Institute UCSD in progress, not accepting new patients
    La Jolla California 92037 United States
  • Jules Stein Eye Institute/ UCLA in progress, not accepting new patients
    Los Angeles California 90095-7000 United States
  • UCSF; Ophthalmology in progress, not accepting new patients
    San Francisco California 94143 United States
  • West Coast Retina Medical Group in progress, not accepting new patients
    San Francisco California 94109 United States
  • Retina-Vitreous Associates Medical Group in progress, not accepting new patients
    Beverly Hills California 90211 United States
  • The Retina Partners in progress, not accepting new patients
    Encino California 91436 United States
  • Orange County Retina Med Group in progress, not accepting new patients
    Santa Ana California 92705 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT03683251
Phase
Phase 3
Study Type
Interventional
Last Updated