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NCT01565148 · ClinicalTrials.gov registry record · Phase 2
A Randomized, Multi-center, Phase II Study of the Safety, Tolerability and Bioactivity of Repeated Intravitreal Injections of iCo-007 as Monotherapy or in Combination With Ranibizumab or Laser Photocoagulation in the Treatment of Diabetic Macular Edema (the iDEAL Study)
A Phase 2 study, sponsored by Johns Hopkins University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 185
- Enrollment target
NCT01565148: Clinical Trial Phase 2 study, sponsored by Johns Hopkins University.
NCT01565148 is a Phase 2 study that was terminated before completion, run by Johns Hopkins University. The registered enrollment target is 185 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01565148, a Phase 2 study, was terminated before completion, sponsored by Johns Hopkins University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 185 participants
- Enrollment target
Study Summary
* To assess the safety of repeated iCo-007 intravitreal injections in treatment of subjects with diabetic macular edema as monotherapy and in combination with ranibizumab or laser photocoagulation * To assess the change in visual acuity and retinal thickness on optical coherence tomography (OCT) from baseline to month 8 and month 12
Interventions
- DRUG iCo-007 350 mcg
- DRUG iCo-007 700 mcg
- DRUG iCo-007 350 mcg and Laser
- DRUG Ranibizumab and iCo-007 350 mcg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 185 participants |
| Start Date | 2012-02 |
| Est. Completion | 2014-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01565148
The ClinicalTrials.gov registry entry for NCT01565148 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 185 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which iCo-007 350 mcg is the first listed.
NCT01565148 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01565148 about?
NCT01565148 is a clinical study titled "A Randomized, Multi-center, Phase II Study of the Safety, Tolerability and Bioactivity of Repeated Intravitreal Injections of iCo-007 as Monotherapy or in Combination With Ranibizumab or Laser Photocoagulation in the Treatment of Diabetic Macular Edema (the iDEAL Study)". * To assess the safety of repeated iCo-007 intravitreal injections in treatment of subjects with diabetic macular edema as monotherapy and in combination with ranibizumab or laser photocoagulation * To assess the change in visual acuity and retinal thickness on optical coherence tomography (OCT) fro...
What is the current status of trial NCT01565148?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 185 participants. The study started on 2012-02. Estimated completion is 2014-10.
What interventions are being tested in trial NCT01565148?
The interventions under investigation include: iCo-007 350 mcg (DRUG), iCo-007 700 mcg (DRUG), iCo-007 350 mcg and Laser (DRUG), Ranibizumab and iCo-007 350 mcg (DRUG).
Who is sponsoring clinical trial NCT01565148?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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