A Phase 2 Study Exploring The Safety And Efficacy Of Novel Drug Treatment In Subjects With Diabetic Macular Edema (DME)
NCT00457470
ABOUT THIS STUDY
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Adult Trials: 18+ Years
- diabetic patients, either man or woman, with diabetic retinopathy, at least 18 years of age
- patients treated with laser therapy within the last 90 days
- patients with likelyhood to require cataract surgery within 3 months
- Uncontrolled diabetes
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | A Phase 2 Study Exploring The Safety And Efficacy Of Novel Drug Treatment In Subjects With Diabetic Macular Edema (DME) | |||
| Official Title ICMJE | A Phase 2, Multi-Stage, Multi-Center Trial Exploring The Safety And Efficacy Of AG-014699 In Subjects With Diffuse Diabetic Macular Edema (DME) Involving The Center Of The Retina | |||
| Brief Summary | This study will evaluate the safety and efficacy of AG-014699 in diabetic patients | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 2 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | |||
| Condition ICMJE |
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| Intervention ICMJE | Drug: AG-014699 | |||
| Study Arms ICMJE | Not Provided | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Withdrawn | |||
| Actual Enrollment ICMJE | 0 | |||
| Original Enrollment ICMJE | 80 | |||
| Study Completion Date ICMJE | Not Provided | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Not Provided | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00457470 | |||
| Other Study ID Numbers ICMJE | A4991010 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Not Provided | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
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| PRS Account | Pfizer | |||
| Verification Date | April 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||