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

Phase 2

Withdrawn

• Conditions: Diabetic Retinopathy; Diabetes Mellitus

• Registration Number: NCT00457470
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-04-04
• Study First Submitted QC: 2007-04-05
• Study First Posted: 2007-04-06
• Study Start: 2007-06
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-30
• Last Update Posted: 2015-05-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• diabetic patients, either man or woman, with diabetic retinopathy, at least 18 years of age

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Exclusion Criteria

• patients treated with laser therapy within the last 90 days
• patients with likelyhood to require cataract surgery within 3 months
• Uncontrolled diabetes

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change of retinal thickness at Day 15 or Day 25 depending on dosing regimen

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects with reduction in retinal thickness from baseline in 2 months
Change in visual acuity for 2 months
; Proportion of eyes experiencing an improvement in the degree of retinopathy at Day 28
Change in retinal thickness for 2 months