Phase 1 Study of VEGF Trap in Patients With Diabetic Macular Edema

NCT ID: NCT00320814

Last Updated: 2011-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2007-08-31

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. Patients will be observed for six weeks following the injection for assessments of ocular and systemic safety.

Conditions

Diabetic Macular Edema

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VEGF Trap-Eye

single IVT injection of 4.0 mg of VEGF Trap-Eye into the study eye on Day 1

Group Type: EXPERIMENTAL

VEGF Trap-Eye

Intervention Type: DRUG

single IVT injection of 4.0 mg of VEGF Trap-Eye into the study eye on Day 1

Interventions

VEGF Trap-Eye

single IVT injection of 4.0 mg of VEGF Trap-Eye into the study eye on Day 1

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Regeneron Pharmaceuticals, Inc.

Principal Investigators

Avner Ingerman, MD

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

Baltimore, Maryland, United States

Charlotte, North Carolina, United States

Countries

United States

Other Identifiers

VGFT-OD-0512

Identifier Type: -

Identifier Source: org_study_id