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

This study has been withdrawn prior to enrollment.
(Cancelled before first patient enrolled)
Information provided by:
Pfizer Identifier:
First received: April 4, 2007
Last updated: April 30, 2015
Last verified: April 2015
This study will evaluate the safety and efficacy of AG-014699 in diabetic patients

Condition Intervention Phase
Diabetes Mellitus
Diabetic Retinopathy
Drug: AG-014699
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Pfizer:

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

Enrollment: 0
Study Start Date: June 2007

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00457470

Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information: Identifier: NCT00457470     History of Changes
Other Study ID Numbers: A4991010 
Study First Received: April 4, 2007
Last Updated: April 30, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Macular Edema
Diabetic Retinopathy
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents processed this record on October 25, 2016