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NCT03683251 · ClinicalTrials.gov registry record · Phase 3
Extension Study for the Port Delivery System With Ranibizumab (Portal)
A Phase 3 study of Neovascular Age-related Macular Degeneration, sponsored by Hoffmann-La Roche.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 1,000
- Enrollment target
- 20
- Study locations
NCT03683251 is a Phase 3 study of Neovascular Age-related Macular Degeneration that is actively recruiting participants, run by Hoffmann-La Roche. The registered enrollment target is 1,000 participants, above the 378-participant average among 33 other Neovascular Age-related Macular Degeneration trials with a reported enrollment target (165% higher). The trial reports 20 study locations across 3 states.
The verdict
NCT03683251, a Phase 3 study of Neovascular Age-related Macular Degeneration, is actively recruiting participants, sponsored by Hoffmann-La Roche.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,000 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG PDS Implant with Ranibizumab 100 mg/mL
Study Locations (20)
California
- California Retina Consultants - Bakersfield
- Retina-Vitreous Associates Medical Group - Beverly Hills
- The Retina Partners - Encino
- Jacobs Retina center at the Shiley eye Institute UCSD - La Jolla
- Jules Stein Eye Institute/ UCLA - Los Angeles
- N CA Retina Vitreous Assoc - Mountain View
- Retina Consultants, San Diego - Poway
- Retinal Consultants Med Group - Sacramento
- West Coast Retina Medical Group - San Francisco
- UCSF - San Francisco
- Orange County Retina Med Group - Santa Ana
- California Retina Consultants - Santa Barbara
Arizona
- Retinal Research Institute, LLC - Phoenix
- Arizona Retina and Vitreous Consultants - Phoenix
- Barnet Dulaney Perkins Eye Center - Phoenix
- Associated Retina Consultants - Phoenix
- Retinal Consultants of Arizona - Phoenix
Colorado
- Southwest Retina Consultants - Durango
- Eye Center of Northern CO - Fort Collins
- Colorado Retina Associates, PC - Lakewood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2018-09-20 |
| Est. Completion | 2029-10-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03683251
The ClinicalTrials.gov registry entry for NCT03683251 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 378-participant average among 33 other Neovascular Age-related Macular Degeneration trials with a reported enrollment target (165% higher). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Neovascular Age-related Macular Degeneration appearing as the primary indexed condition, and to 1 intervention - of which PDS Implant with Ranibizumab 100 mg/mL is the first listed.
NCT03683251 reports 20 study locations spanning 3 distinct geographic areas - top geographies include California, Arizona, Colorado.
Frequently Asked Questions
What is clinical trial NCT03683251 about?
NCT03683251 is a clinical study titled "Extension Study for the Port Delivery System With Ranibizumab (Portal)". 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 I...
What is the current status of trial NCT03683251?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,000 participants. The study started on 2018-09-20. Estimated completion is 2029-10-31.
What conditions does trial NCT03683251 study?
This clinical trial studies the following conditions: Neovascular Age-related Macular Degeneration.
What interventions are being tested in trial NCT03683251?
The interventions under investigation include: PDS Implant with Ranibizumab 100 mg/mL (DRUG).
Who is sponsoring clinical trial NCT03683251?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03683251 being conducted?
This trial has 20 study locations across Arizona, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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