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This study has been withdrawn prior to enrollment.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)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00457470
First received: April 4, 2007
Last updated: June 25, 2007
Last verified: June 2007
  Purpose

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

Estimated Enrollment: 80
Study Start Date: June 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT00457470

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00457470     History of Changes
Other Study ID Numbers: A4991010
Study First Received: April 4, 2007
Last Updated: June 25, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetic Retinopathy
Macular Edema
Retinal Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Macular Degeneration
Retinal Degeneration

ClinicalTrials.gov processed this record on August 21, 2014