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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: Completed Phase 3 study, sponsored by Charles C Wykoff, PhD, MD.
NCT01748292 is a Phase 3 study that has completed, run by Charles C Wykoff, PhD, MD. The registered enrollment target is 60 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Mean change in Best-Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score from baseline through weeks 24-28, baseline through weeks 48-56, baseline through weeks 72-82, baseline to week 104, baseline through weeks 128-132 and baseline to week 156. The ETDRS protocol is a widely accepted international standard for macular laser photocoagulation treatment. A higher score represents better functioning. The scale ranges from 0 to 100 letters
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 |
What the finished NCT01748292 record still lists
NCT01748292 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which 0.5 mg ranibizumab is the first listed.
NCT01748292 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01748292's enrollment target sits among peer trials
60 1804th of 2000 higher than 177 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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