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NCT03677934 · ClinicalTrials.gov registry record · Phase 3
A Phase III Study to Evaluate the Port Delivery System With Ranibizumab Compared With Monthly Ranibizumab Injections in Participants With Wet Age-Related Macular Degeneration
A Phase 3 study of Neovascular Age-related Macular Degeneration, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 415
- Enrollment target
- 20
- Study locations
NCT03677934: Completed Phase 3 study of Neovascular Age-related Macular Degeneration, sponsored by Hoffmann-La Roche.
NCT03677934 is a Phase 3 study of Neovascular Age-related Macular Degeneration that has completed, run by Hoffmann-La Roche. The registered enrollment target is 415 participants, roughly in line with the 396-participant average among 33 other Neovascular Age-related Macular Degeneration trials with a reported enrollment target. The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03677934, a Phase 3 study of Neovascular Age-related Macular Degeneration, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 415 participants
- Enrollment target
- 20
- Study locations
Study Summary
Study GR40548 is a Phase III, randomized, multicenter, open-label (visual assessor \[VA\]-masked), active-comparator study designed to assess the efficacy, safety, and pharmacokinetics (PK) of 100mg/ml delivered via the Port Delivery System with ranibizumab (PDS) compared with ranibizumab intravitreal injections at 0.5 mg (10 mg/mL) in participants with neovascular age-related macular degeneration (nAMD).
Primary Outcome
The primary efficacy endpoint is the change in BCVA score from baseline averaged over Weeks 36 and 40 with BCVA assessed using the ETDRS chart at a starting distance of 4 meters. ETDRS = Early Treatment Diabetic Retinopathy Study. The primary objective is to determine the NI and equivalence between the two treatment groups, as measured by the primary efficacy endpoint with a NI margin of 4.5 letters and equivalence margins of ± 4.5 letters. A vision score of 20/20 vision is considered normal.
Conditions Studied
Interventions
- DRUG PDS Implant filled with 100 mg/mL Ranibizumab
- DRUG Intravitreal Injections of 10 mg/mL Ranibizumab
Study Locations (20)
California
- California Retina Consultants - Bakersfield
- Retina-Vitreous Associates Medical Group - Beverly Hills
- The Retina Partners - Encino
- 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; Ophthalmology - San Francisco
- Orange County Retina Med Group - Santa Ana
- California Retina Consultants - Santa Barbara
- Bay Area Retina Associates - Walnut Creek
Arizona
- Barnet Dulaney Perkins Eye Center - Mesa
- Associated Retina Consultants - Phoenix
- Arizona Retina and Vitreous Consultants - Phoenix
- Retinal Consultants of Arizona - Phoenix
Colorado
- Southwest Retina Consultants - Durango
- Eye Center of Northern CO - Fort Collins
- Colorado Retina Associates, PC - Lakewood
Connecticut
- Retina Group of New England - Waterford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 415 participants |
| Start Date | 2018-09-12 |
| Est. Completion | 2021-06-09 |
| Phase | Phase 3 |
What the finished NCT03677934 record still lists
NCT03677934 is an interventional study that assigns participants to a tested intervention. The registered 415 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 396-participant average among 33 other Neovascular Age-related Macular Degeneration trials with a reported enrollment target.
The record links to 1 condition, with Neovascular Age-related Macular Degeneration appearing as the primary indexed condition, and to 2 interventions - of which PDS Implant filled with 100 mg/mL Ranibizumab is the first listed.
NCT03677934 names 20 study sites across 4 states, led by California, Arizona, Colorado.
Frequently Asked Questions
What is clinical trial NCT03677934 about?
NCT03677934 is a clinical study titled "A Phase III Study to Evaluate the Port Delivery System With Ranibizumab Compared With Monthly Ranibizumab Injections in Participants With Wet Age-Related Macular Degeneration". Study GR40548 is a Phase III, randomized, multicenter, open-label (visual assessor \[VA\]-masked), active-comparator study designed to assess the efficacy, safety, and pharmacokinetics (PK) of 100mg/ml delivered via the Port Delivery System with ranibizumab (PDS) compared with ranibizumab intravitre...
What is the current status of trial NCT03677934?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 415 participants. The study started on 2018-09-12. Estimated completion is 2021-06-09.
What conditions does trial NCT03677934 study?
This clinical trial studies the following conditions: Neovascular Age-related Macular Degeneration.
What interventions are being tested in trial NCT03677934?
The interventions under investigation include: PDS Implant filled with 100 mg/mL Ranibizumab (DRUG), Intravitreal Injections of 10 mg/mL Ranibizumab (DRUG).
Who is sponsoring clinical trial NCT03677934?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03677934 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Neovascular Age-related Macular Degeneration
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03677934's enrollment target sits among peer trials
415 8th of 33 higher than 26 of 33 other Neovascular Age-related Macular Degeneration trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neovascular Age-related Macular Degeneration trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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