This study will measure the long-term whether it is safe and how hard side effects are to live with 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 randomly assigned in WR42221.
Official registry: https://clinicaltrials.gov/study/NCT03683251 · Hoffmann-La Roche · enrollment listed as 1,000
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
If you join, the listed intervention(s) are PDS Implant with Ranibizumab 100 mg/mL. The registry lists allocation as randomized. This study will measure the long-term whether it is safe and how hard side effects are to live with 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 randomly assigned in WR42221.
They plan to enroll about 1,000 people at 165 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
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)
Interventions: PDS Implant with Ranibizumab 100 mg/mL
Primary outcome (registry wording): Incidence and Severity of Ocular and Systemic (Non-Ocular) Adverse Events (AEs)
Reference Study ID Number: GR40549 https://forpatients.roche.com/ No attachments to email below.
888-662-6728 (U.S. and Canada)
global-roche-genentech-trials@gene.com
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
+ 84 sites outside the US on the same record
Background: \- Best Vitelliform Dystrophy (Best disease), Late-Onset Retinal Degeneration (L-ORD), and Age-Related Macular Degeneration (AMD) all affect the retina, the light sensing area at the back of the eye. Doctors cannot safely obtain retinal cells to study these diseases.
NCT01432847 · Official ClinicalTrials.gov record · National Eye Institute (NEI)
Background: \- To understand diseases of the retina and the eye, information is needed about people with and without such diseases. Researchers want to study these people and follow them over time.
NCT01496625 · Official ClinicalTrials.gov record · National Eye Institute (NEI)
Background: Age-related macular degeneration is a common eye disease in people over 50. The "dry" form of the disease can worsen into geographic atrophy, causing blind spots.
NCT04339764 · Official ClinicalTrials.gov record · National Eye Institute (NEI)
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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