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NCT01748292 · ClinicalTrials.gov registry record · Phase 3
Treat & Extend Treatment With 0.5mg Ranibizumab vs Monthly Treatment With 0.5mg Ranibizumab
A Phase 3 study, sponsored by Charles C Wykoff, PhD, MD.
- Completed
- Registry status
- Phase 3
- Development phase
- 60
- Enrollment target
NCT01748292 is a Phase 3 study that has completed, run by Charles C Wykoff, PhD, MD. The registered enrollment target is 60 participants.
The verdict
NCT01748292, a Phase 3 study, has completed, sponsored by Charles C Wykoff, PhD, MD.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 60 participants
- Enrollment target
Study Summary
TREX is a phase IIIb, multicenter, randomized, controlled clinical study. Subjects will be randomized 1:2 to "monthly" (control arm) or "treat and extend" protocol (comparator arm) respectively. TREX assess the safety, tolerability and efficacy of intravitreal injections (IVT) of 0.5mg ranibizumab given monthly for up to 100 weeks followed by pro re nata (PRN) treatment for 56 weeks compared to a Treat and Extend protocol for 156 weeks in patients with wet age-related macular degeneration (AMD). Subjects treated in a treat and extend protocol receive 3 consecutive IVT 0.5 mg ranibizumab (visits 2, 4 and 5). Starting at week 8, if a subject has achieved a "dry" macula; signs of active exudation have resolved will begin a Treat and Extend protocol (visits lengthened by 2 week intervals every visit a dry macular is maintained). At the beginning of the 104-week endpoint subjects initially randomized to the TREX cohort will transition to PRN re-treatment when there is no exudative disease activity at the 12-week interval.
Interventions
- DRUG 0.5 mg ranibizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2012-12 |
| Est. Completion | 2017-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01748292
The ClinicalTrials.gov registry entry for NCT01748292 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Charles C Wykoff, PhD, MD, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which 0.5 mg ranibizumab is the first listed.
NCT01748292 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01748292 about?
NCT01748292 is a clinical study titled "Treat & Extend Treatment With 0.5mg Ranibizumab vs Monthly Treatment With 0.5mg Ranibizumab". TREX is a phase IIIb, multicenter, randomized, controlled clinical study. Subjects will be randomized 1:2 to "monthly" (control arm) or "treat and extend" protocol (comparator arm) respectively. TREX assess the safety, tolerability and efficacy of intravitreal injections (IVT) of 0.5mg ranibizumab g...
What is the current status of trial NCT01748292?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 60 participants. The study started on 2012-12. Estimated completion is 2017-02.
What interventions are being tested in trial NCT01748292?
The interventions under investigation include: 0.5 mg ranibizumab (DRUG).
Who is sponsoring clinical trial NCT01748292?
This trial is sponsored by Charles C Wykoff, PhD, MD, which has 3 total clinical trials registered on ClinicalTrials.gov.
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