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

Phase 2WithdrawnNCT00457470

Pfizer

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Diabetes Mellitus Diabetic Retinopathy

Interventions

AG-014699DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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