A Phase 2 Study Exploring The Safety And Efficacy Of Novel Drug Treatment In Subjects With Diabetic Macular Edema (DME)

NCT00457470

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Diabetes Mellitus, Diabetic Retinopathy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- diabetic patients, either man or woman, with diabetic retinopathy, at least 18 years of age

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Diabetes Mellitus, Diabetic RetinopathyA Phase 2 Study Exploring The Safety And Efficacy Of Novel Drug Treatment In Subjects With Diabetic Macular Edema (DME) NCT00457470
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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
  • Diabetes Mellitus
  • Diabetic Retinopathy
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Recruitment Status  ICMJE Withdrawn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
 (submitted: April 30, 2015)
0
Original Enrollment  ICMJE
 (submitted: April 5, 2007)
80
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • diabetic patients, either man or woman, with diabetic retinopathy, at least 18 years of age

Exclusion Criteria:

  • patients treated with laser therapy within the last 90 days
  • patients with likelyhood to require cataract surgery within 3 months
  • Uncontrolled diabetes
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Study Director:Pfizer CT.gov Call CenterPfizer
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