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

This study has been completed.
Sponsor:
Information provided by:
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00320814
First received: April 28, 2006
Last updated: June 8, 2011
Last verified: June 2011
  Purpose

To assess the ocular and systemic safety and tolerability of a single intravitreal injection of VEGF Trap in patients with diabetic macular edema.


Condition Intervention Phase
Diabetic Macular Edema
Drug: VEGF Trap-Eye
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Exploratory Study of the Safety, Tolerability and Biological Effect of a Single Intravitreal Administration of VEGF Trap in Patients With Diabetic Macular Edema

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • 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) [ Time Frame: Assessments for safety and tolerablity are performed at each visit (Visit 1 - Visit 10) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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) [ Time Frame: Assessments for CRT are performed at each visit (Visit 1 - Visit 10) by means of OCT. ] [ Designated as safety issue: No ]
  • To obtain a preliminary assessment of the effect of a single IVT administration of VEGF Trap-Eye on visual acuity [ Time Frame: Assessments for visual acuity are performed at each visit (Visit 1 - Visit 10). ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: April 2006
Study Completion Date: August 2007
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VEGF Trap-Eye
single IVT injection of 4.0 mg of VEGF Trap-Eye into the study eye on Day 1
Drug: VEGF Trap-Eye
single IVT injection of 4.0 mg of VEGF Trap-Eye into the study eye on Day 1

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00320814

Locations
United States, Maryland
Baltimore, Maryland, United States, 21287
United States, North Carolina
Charlotte, North Carolina, United States, 28210
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
Study Director: Avner Ingerman, MD Regeneron Pharmaceuticals
  More Information

No publications provided

Responsible Party: Avner Ingerman, MD/Medical Monitor, Regeneron Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00320814     History of Changes
Other Study ID Numbers: VGFT-OD-0512
Study First Received: April 28, 2006
Last Updated: June 8, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Macular Edema
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014