Back to resultsA Phase 2 Study Exploring The Safety And Efficacy Of Novel Drug Treatment In Subjects With Diabetic Macular Edema (DME)
Primary Purpose
Diabetes Mellitus, Diabetic Retinopathy
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
AG-014699
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Change of retinal thickness at Day 15 or Day 25 depending on dosing regimen
Secondary Outcome Measures
Proportion of subjects with reduction in retinal thickness from baseline in 2 months
Change in retinal thickness for 2 months
Change in visual acuity for 2 months
; Proportion of eyes experiencing an improvement in the degree of retinopathy at Day 28
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00457470
Brief Title
A Phase 2 Study Exploring The Safety And Efficacy Of Novel Drug Treatment In Subjects With Diabetic Macular Edema (DME)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Cancelled before first patient enrolled
Study Start Date
June 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
5. Study Description
Brief Summary
This study will evaluate the safety and efficacy of AG-014699 in diabetic patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Diabetic Retinopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
AG-014699
Primary Outcome Measure Information:
Title
Change of retinal thickness at Day 15 or Day 25 depending on dosing regimen
Secondary Outcome Measure Information:
Title
Proportion of subjects with reduction in retinal thickness from baseline in 2 months
Title
Change in retinal thickness for 2 months
Title
Change in visual acuity for 2 months
Title
; Proportion of eyes experiencing an improvement in the degree of retinopathy at Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4991010&StudyName=A%20Phase%202%20Study%20Exploring%20The%20Safety%20And%20Efficacy%20Of%20Novel%20Drug%20Treatment%20In%20Subjects%20With%20Diabetic%20Macular%20Edema%20%28DME%29
Description
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Learn more about this trial
A Phase 2 Study Exploring The Safety And Efficacy Of Novel Drug Treatment In Subjects With Diabetic Macular Edema (DME)
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