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NCT01945866 · ClinicalTrials.gov registry record · Phase 2
Phase II Combination Steroid and Anti-VEGF for Persistent DME
A Phase 2 study, sponsored by Jaeb Center for Health Research.
- Completed
- Registry status
- Phase 2
- Development phase
- 129
- Enrollment target
NCT01945866 is a Phase 2 study that has completed, run by Jaeb Center for Health Research. The registered enrollment target is 129 participants.
The verdict
NCT01945866, a Phase 2 study, has completed, sponsored by Jaeb Center for Health Research.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 129 participants
- Enrollment target
Study Summary
Although anti-vascular endothelial growth factor (VEGF) therapy is generally effective as treatment for center-involved diabetic macular edema (DME), a substantial proportion of anti-VEGF-treated eyes with DME do not achieve vision of 20/20 or complete resolution of retinal thickening. Indeed, over 50% of ranibizumab-treated eyes did not achieve a 2 or more line improvement in visual acuity from baseline at 2 years in Protocol I, a previous DRCR.net (Diabetic Retinopathy Clinical Research Network) study. Furthermore, 27% of ranibizumab-treated eyes still had central subfield (CSF) thickness on time-domain optical coherence tomography (OCT) ≥ 300 at 1 year, and more than 40% of ranibizumab-treated eyes did not achieve complete resolution of retinal thickening (\< 250 microns) by 2 years. Thus, there is a need for alternative or additional treatments that will improve vision by reducing retinal edema in eyes with persistent DME following previous anti-VEGF therapy. Intravitreal steroid is not as efficacious as ranibizumab in eyes with DME overall, but it has been shown to have a positive effect for DME in some eyes and might add benefit in eyes that are already receiving anti-VEGF. The main objective of this study is to assess the short-term effects of combination steroid+anti-VEGF therapy on visual acuity and retinal thickness on OCT in comparison with that of continued anti-VEGF therapy alone in eyes with persistent central-involved DME and visual acuity impairment despite previous anti-VEGF treatment. This study will provide important information for the design of a future confirmatory phase III clinical trial on the efficacy of combination steroid and anti-VEGF in eyes with persistent DME and vision impairment following previous anti-VEGF therapy. The primary outcome for efficacy will be the mean change in visual acuity at 24 weeks. Each study eye is required to complete a 12-week run-in phase. The run-in phase will identify study eyes that truly have persistent
Interventions
- DRUG dexamethasone intravitreal implant
- DRUG intravitreal ranibizumab 0.3 mg
- PROCEDURE Sham injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2014-02 |
| Est. Completion | 2017-06-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01945866
The ClinicalTrials.gov registry entry for NCT01945866 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 129 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 3 interventions - of which dexamethasone intravitreal implant is the first listed.
NCT01945866 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01945866 about?
NCT01945866 is a clinical study titled "Phase II Combination Steroid and Anti-VEGF for Persistent DME". Although anti-vascular endothelial growth factor (VEGF) therapy is generally effective as treatment for center-involved diabetic macular edema (DME), a substantial proportion of anti-VEGF-treated eyes with DME do not achieve vision of 20/20 or complete resolution of retinal thickening. Indeed, over ...
What is the current status of trial NCT01945866?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 129 participants. The study started on 2014-02. Estimated completion is 2017-06-05.
What interventions are being tested in trial NCT01945866?
The interventions under investigation include: dexamethasone intravitreal implant (DRUG), intravitreal ranibizumab 0.3 mg (DRUG), Sham injection (PROCEDURE).
Who is sponsoring clinical trial NCT01945866?
This trial is sponsored by Jaeb Center for Health Research, which has 119 total clinical trials registered on ClinicalTrials.gov.
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