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)
Hoffmann-La Roche
Summary
This study will evaluate the long-term safety and tolerability of the Port Delivery System with ranibizumab (PDS) (100 mg/mL) in participants with neovascular age-related macular degeneration (nAMD) who have either completed Phase II Study GX28228 (Ladder), Phase III Study GR40548 (Archway), Phase IIIb Study WR42221 (Velodrome), or completed Week 24 visit in Study WR42221 but were not eligible to be randomized in WR42221.
Description
The Transscleral Photocoagulation sub-study (sub-study 1) will evaluate the effectiveness of using transscleral photocoagulation (TPC) with the Iridex laser system to mitigate vitreous hemorrhages secondary to the Port Delivery System with ranibizumab (PDS) implantation procedure in participants with neovascular age-related macular degeneration (nAMD). The sub-study will enroll about 55 participants. The Re-implantation sub-study (sub-study 2) will evaluate the safety of re-implantation with the updated PDS with ranibizumab . Up to 100 participants who previously participated in the main stud…
Eligibility
- Age range
- 50+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Exclusion Criteria: * Pregnant or breastfeeding, or intending to become…
Interventions
- DrugPDS Implant with Ranibizumab 100 mg/mL
Will be administered as per the schedule described in individual arm
Locations (165)
- Retinal Research Institute, LLCPhoenix, Arizona
- Arizona Retina and Vitreous ConsultantsPhoenix, Arizona
- Barnet Dulaney Perkins Eye CenterPhoenix, Arizona
- Associated Retina ConsultantsPhoenix, Arizona
- Retinal Consultants of ArizonaPhoenix, Arizona
- California Retina ConsultantsBakersfield, California