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NCT04005352 · ClinicalTrials.gov registry record · Phase 3
Study to Assess the Efficacy and Safety of Brolucizumab 6mg Compared to Aflibercept 2 mg in a Treat-to-control Regimen (TALON)
A Phase 3 study of Age-related Macular Degeneration, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 734
- Enrollment target
- 20
- Study locations
NCT04005352: Completed Phase 3 study of Age-related Macular Degeneration, sponsored by Novartis Pharmaceuticals.
NCT04005352 is a Phase 3 study of Age-related Macular Degeneration that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 734 participants, below the 1,498-participant average among 74 other Age-related Macular Degeneration trials with a reported enrollment target (51% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04005352, a Phase 3 study of Age-related Macular Degeneration, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 734 participants
- Enrollment target
- 20
- Study locations
Study Summary
This was a 64-week randomized, double-masked, multi-center, active-controlled, two-arm study in patients with neovascular age related macular degeneration (nAMD) who have not previously received anti- vascular endothelial growth factor (VEGF) treatment.
Primary Outcome
No disease activity is defined as no change in visual acuity and no change in other signs of the disease (e.g. Intraretinal Fluid (IRF), Subretinal Fluid (SRF), hemorrhage, leakage, etc.). Treatment interval distribution. Number (%) of subjects at 12/8/4-weeks intervals up to Week 32 for the study eye. If the study treatment is discontinued before Week 16, then the treatment interval is 4 weeks; otherwise. the last interval with no disease activity is used (if there was disease activity, the l
Conditions Studied
Interventions
- BIOLOGICAL Brolucizumab 6 mg
- BIOLOGICAL Aflibercept 2 mg
Study Locations (20)
Florida
- Novartis Investigative Site - Fort Lauderdale
- Novartis Investigative Site - Fort Myers
- Novartis Investigative Site - Orlando
- Novartis Investigative Site - Pinellas Park
- Novartis Investigative Site - Winter Haven
California
- Novartis Investigative Site - Huntington Beach
- Novartis Investigative Site - Loma Linda
- Novartis Investigative Site - Riverside
- Novartis Investigative Site - Santa Ana
Oregon
- Novartis Investigative Site - Portland
- Novartis Investigative Site - Springfield
Texas
- Novartis Investigative Site - Austin
- Novartis Investigative Site - Bellaire
Arizona
- Novartis Investigative Site - Phoenix
Illinois
- Novartis Investigative Site - Springfield
Indiana
- Novartis Investigative Site - Indianapolis
Iowa
- Novartis Investigative Site - West Des Moines
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 734 participants |
| Start Date | 2019-09-25 |
| Est. Completion | 2022-09-09 |
| Phase | Phase 3 |
What the finished NCT04005352 record still lists
NCT04005352 is an interventional study that assigns participants to a tested intervention. The registered 734 participants enrollment target is mid-sized for trials with a published cap, below the 1,498-participant average among 74 other Age-related Macular Degeneration trials with a reported enrollment target (51% lower).
The record links to 1 condition, with Age-related Macular Degeneration appearing as the primary indexed condition, and to 2 interventions - of which Brolucizumab 6 mg is the first listed.
NCT04005352 names 20 study sites across 11 states, led by Florida, California, Oregon.
Frequently Asked Questions
What is clinical trial NCT04005352 about?
NCT04005352 is a clinical study titled "Study to Assess the Efficacy and Safety of Brolucizumab 6mg Compared to Aflibercept 2 mg in a Treat-to-control Regimen (TALON)". This was a 64-week randomized, double-masked, multi-center, active-controlled, two-arm study in patients with neovascular age related macular degeneration (nAMD) who have not previously received anti- vascular endothelial growth factor (VEGF) treatment.
What is the current status of trial NCT04005352?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 734 participants. The study started on 2019-09-25. Estimated completion is 2022-09-09.
What conditions does trial NCT04005352 study?
This clinical trial studies the following conditions: Age-related Macular Degeneration.
What interventions are being tested in trial NCT04005352?
The interventions under investigation include: Brolucizumab 6 mg (BIOLOGICAL), Aflibercept 2 mg (BIOLOGICAL).
Who is sponsoring clinical trial NCT04005352?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04005352 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for 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 NCT04005352's enrollment target sits among peer trials
734 6th of 74 higher than 69 of 74 other Age-related Macular Degeneration trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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.
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