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

NCT00320814 | Completed Phase 1

• 1 other identifier: VGFT-OD-0512
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• To assess the ocular and systemic safety and tolerability of a single intravitreal (IVT) injection of VEGF Trap-Eye in patients with diabetic macular edema (DME)

  Assessments for safety and tolerablity are performed at each visit (Visit 1 - Visit 10)

Secondary Outcomes (2)

• To obtain a preliminary assessment of the effect of a single dose of VEGF Trap-Eye on central retinal thickness (CRT) at the center point as determined by optical coherence tomography (OCT)

  Assessments for CRT are performed at each visit (Visit 1 - Visit 10) by means of OCT.

• To obtain a preliminary assessment of the effect of a single IVT administration of VEGF Trap-Eye on visual acuity

  Assessments for visual acuity are performed at each visit (Visit 1 - Visit 10).

Study Arms (1)

VEGF Trap-Eye

EXPERIMENTAL

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

Drug: VEGF Trap-Eye

Interventions

VEGF Trap-Eye DRUG

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

VEGF Trap-Eye

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (2)

Unknown Facility

Baltimore, Maryland, 21287, United States

Location

Unknown Facility

Charlotte, North Carolina, 28210, United States

Location

MeSH Terms

Interventions

aflibercept

Study Officials

• Avner Ingerman, MD

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 28, 2006
• First Posted: May 3, 2006
• Study Start: April 1, 2006
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2007
• Last Updated: June 10, 2011

Record last verified: 2011-06

Locations

US (2)