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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00457470
• Date of registration: 04/04/2007
• Primary sponsor: Pfizer
• Public title: A Phase 2 Study Exploring The Safety And Efficacy Of Novel Drug Treatment In Subjects With Diabetic Macular Edema (DME)
• Scientific 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
• Date of first enrolment: June 2007
• Target sample size: 80
• Recruitment status: Withdrawn
• URL: http://clinicaltrials.gov/show/NCT00457470
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetes Mellitus

Diabetic Retinopathy

Intervention(s)

Drug: AG-014699

Primary Outcome(s)

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

Secondary Outcome(s)

; Proportion of eyes experiencing an improvement in the degree of retinopathy at Day 28

Change in retinal thickness for 2 months

Change in visual acuity for 2 months

Proportion of subjects with reduction in retinal thickness from baseline in 2 months

Secondary ID(s)

A4991010

Source(s) of Monetary Support

Please refer to primary and secondary sponsors