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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00457470
Recruitment Status : Withdrawn (Cancelled before first patient enrolled)
First Posted : April 6, 2007
Last Update Posted : May 4, 2015
Information provided by:

Brief Summary:
This study will evaluate the safety and efficacy of AG-014699 in diabetic patients

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Diabetic Retinopathy Drug: AG-014699 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
Drug Information available for: Rucaparib
U.S. FDA Resources

Primary Outcome Measures :
  1. Change of retinal thickness at Day 15 or Day 25 depending on dosing regimen

Secondary Outcome Measures :
  1. Proportion of subjects with reduction in retinal thickness from baseline in 2 months
  2. Change in retinal thickness for 2 months
  3. Change in visual acuity for 2 months
  4. ; Proportion of eyes experiencing an improvement in the degree of retinopathy at Day 28

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00457470

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

Additional Information:
ClinicalTrials.gov Identifier: NCT00457470     History of Changes
Other Study ID Numbers: A4991010
First Posted: April 6, 2007    Key Record Dates
Last Update Posted: May 4, 2015
Last Verified: April 2015

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