Status:
COMPLETED
Phase 1 Study of VEGF Trap in Patients With Diabetic Macular Edema
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
To assess the ocular and systemic safety and tolerability of a single intravitreal injection of VEGF Trap in patients with diabetic macular edema.
Detailed Description
This is an open label study. Initially, 5 patients with DME will receive an ITV injection of VEGF Trap into the study eye. Additional patients may be enrolled at the same or additional dose levels. Pa...
Eligibility Criteria
Inclusion
- Diagnosis of diabetes mellitus (type 1 or type 2).
- Best corrected E-ETDRS visual acuity score of ≥ 24 letters (i.e., 20/320 or better) and ≤ 73 letters (i.e., 20/40 or worse).
- On clinical exam, definite retinal thickening due to diabetic macular edema involving the center of the macula.
- Retinal Thickness at the center point ≥ 250 microns.
- Media clarity, pupillary dilation, and patient cooperation sufficient for adequate fundus photographs.
Exclusion
- History of any vitreous hemorrhage within 4 weeks prior to Visit 2 (Day 1).
- Macular edema due to causes other than diabetic macular edema. An eye should be considered ineligible: (1) if the macular edema is considered to be related to cataract extraction or (2) clinical exam and/or OCT suggests that vitreoretinal interface disease (e.g., a taut posterior hyaloid or epiretinal membrane) is the primary cause of the macular edema.
- An ocular condition is present such that, in the opinion of the investigator, visual acuity would not improve from resolution of macular edema (e.g., foveal atrophy, pigmentary changes, dense subfoveal hard exudates, nonretinal condition).
- An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., vein occlusion, age-related macular degeneration, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass Syndrome, etc.).
- Presence of any other condition or laboratory abnormality, which, in the opinion of the Investigator, would interfere with the assessment of disease status/progression or jeopardize the patient's appropriate participation in this Phase 1 study.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00320814
Start Date
April 1 2006
End Date
August 1 2007
Last Update
June 10 2011
Active Locations (2)
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1
Baltimore, Maryland, United States, 21287
2
Charlotte, North Carolina, United States, 28210