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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, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (39% higher). 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
Primary Outcome
The primary efficacy variable is the change in visual acuity (mean change in number of letters) from baseline to month 8
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 |
Why NCT01565148 stopped before completion
NCT01565148 is an interventional study that assigns participants to a tested intervention. The registered 185 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (39% higher).
The record links to 0 conditions, and to 4 interventions - of which iCo-007 350 mcg is the first listed.
NCT01565148 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01565148's enrollment target sits among peer trials
185 357th of 2000 higher than 1,641 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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