Extension Study for the Port Delivery System With Ranibizumab (Portal)
Status: | Recruiting |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 50 - Any |
Updated: | 4/5/2019 |
Start Date: | September 20, 2018 |
End Date: | June 24, 2022 |
Contact: | Reference Study ID Number: GR40549 www.roche.com/about_roche/roche_worldwide.htm |
Email: | global-roche-genentech-trials@gene.com |
Phone: | 888-662-6728 (U.S. and Canada) |
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
This study will evaluate the long-term safety and tolerability of the Port Delivery System
(PDS) with ranibizumab 100 mg/mL with refills administered every 24 weeks (Q24W) for
approximately 144 weeks in participants with neovascular age-related macular degeneration
(nAMD) who have completed either Phase II Study GX28228 or Phase III Study GR40548.
(PDS) with ranibizumab 100 mg/mL with refills administered every 24 weeks (Q24W) for
approximately 144 weeks in participants with neovascular age-related macular degeneration
(nAMD) who have completed either Phase II Study GX28228 or Phase III Study GR40548.
Inclusion Criteria:
- Previous enrollment in and completion of Study GX28228 or Study GR40548, without early
treatment or study discontinuation in either study
- 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 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 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"
We found this trial at
47
sites
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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