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NCT00457470 Clinical Trial

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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00457470
Other study ID # A4991010
Secondary ID
Status Withdrawn
Phase Phase 2
First received April 4, 2007
Last updated April 30, 2015
Start date June 2007

Study information
Verified date April 2015
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• AG-014699

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Outcome
Type Measure Description Time frame Safety issue
Primary Change of retinal thickness at Day 15 or Day 25 depending on dosing regimen
Secondary Proportion of subjects with reduction in retinal thickness from baseline in 2 months
Secondary Change in retinal thickness for 2 months
Secondary Change in visual acuity for 2 months
Secondary ; Proportion of eyes experiencing an improvement in the degree of retinopathy at Day 28
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