Clinical trial NCT00320814: Phase 1 Study of VEGF Trap in Patients With Diabetic Macular Edema
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetic Macular Edema
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-05-03
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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)
timeFrame: Assessments for safety and tolerablity are performed at each visit (Visit 1 - Visit 10)
Secondary outcomes:
measure: 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)
timeFrame: Assessments for CRT are performed at each visit (Visit 1 - Visit 10) by means of OCT.
measure: To obtain a preliminary assessment of the effect of a single IVT administration of VEGF Trap-Eye on visual acuity
timeFrame: Assessments for visual acuity are performed at each visit (Visit 1 - Visit 10).
Other outcomes:
Locations:
city: Baltimore
country: United States
state: Maryland
city: Charlotte
country: United States
state: North Carolina
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Avner Ingerman, MD
role: STUDY_DIRECTOR
References: