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NCT03321513 · ClinicalTrials.gov registry record · Phase 3
DRCR.Net Aflibercept vs. Bevacizumab + Deferred Aflibercept for the Treatment of CI-DME
A Phase 3 study, sponsored by Jaeb Center for Health Research.
- Completed
- Registry status
- Phase 3
- Development phase
- 270
- Enrollment target
NCT03321513 is a Phase 3 study that has completed, run by Jaeb Center for Health Research. The registered enrollment target is 270 participants.
The verdict
NCT03321513, a Phase 3 study, has completed, sponsored by Jaeb Center for Health Research.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 270 participants
- Enrollment target
Study Summary
Both aflibercept and bevacizumab have been shown to improve vision in eyes with DME. In eyes with DME and at least moderate vision loss, both aflibercept and bevacizumab were also shown to be successful in many eyes. However, aflibercept was shown to be more effective at improving vision, on average, at 1 year and at 2 years. Due to the large cost difference between the two drugs, many clinicians and patients are choosing to initiate treatment with bevacizumab and then switch to aflibercept depending on the eye's response to bevacizumab treatment. However, there is no scientific evidence that this treatment strategy is as effective at improving vision as initiating treatment with aflibercept. Patients and clinicians do not know if this approach ultimately has deleterious effects on visual acuity. If starting with aflibercept is not better than starting with bevacizumab and switching to aflibercept if needed, the potential cost savings to future patients and the health care system would be substantial. However, if starting with aflibercept is better, then patients, clinicians, and health care providers can make informed decisions for how to best treat patients with DME and at least moderate vision loss. Study Objectives To compare the efficacy of intravitreous aflibercept with intravitreous bevacizumab + deferred aflibercept if needed in eyes with CI DME and moderate vision loss
Interventions
- DRUG intravitreous aflibercept
- DRUG Bevacizumab + Deferred Aflibercept Group
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 270 participants |
| Start Date | 2017-12-07 |
| Est. Completion | 2021-12-22 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03321513
The ClinicalTrials.gov registry entry for NCT03321513 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 270 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jaeb Center for Health Research, which has 119 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which intravitreous aflibercept is the first listed.
NCT03321513 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03321513 about?
NCT03321513 is a clinical study titled "DRCR.Net Aflibercept vs. Bevacizumab + Deferred Aflibercept for the Treatment of CI-DME". Both aflibercept and bevacizumab have been shown to improve vision in eyes with DME. In eyes with DME and at least moderate vision loss, both aflibercept and bevacizumab were also shown to be successful in many eyes. However, aflibercept was shown to be more effective at improving vision, on average...
What is the current status of trial NCT03321513?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 270 participants. The study started on 2017-12-07. Estimated completion is 2021-12-22.
What interventions are being tested in trial NCT03321513?
The interventions under investigation include: intravitreous aflibercept (DRUG), Bevacizumab + Deferred Aflibercept Group (DRUG).
Who is sponsoring clinical trial NCT03321513?
This trial is sponsored by Jaeb Center for Health Research, which has 119 total clinical trials registered on ClinicalTrials.gov.
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