Clinical trial NCT00320775: Safety and Tolerability Study of Intravitreal VEGF-Trap Administration in Patients With Neovascular AMD
Official title: An Exploratory Study of the Safety, Tolerability and Biological Effect of Intravitreal Administration of VEGF Trap in Patients With Neovascular Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Macular Degeneration
Keywords: Neovascular Age-Related Macular Degeneration
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Bayer
First posted: 2006-05-03
Enrollment: 51
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to assess the ocular and systemic safety and tolerability of a single intravitreal injection of VEGF Trap in patients with subfoveal choroidal neovascularization (CNV) due to AMD.

Detailed description: This study consists of three parts, Part A, Part B and Part C. Part A is a dose escalation. Part B was terminated early. The (one) subject who received Macugen is not discussed in this website. Part C had subjects receive one of two doses of VEGF Trap (0.15 mg or 4.0 mg).

This is the first study in which human subjects received intravitreal injections of VEGF Trap in a study eye.

Eligibility criteria: Inclusion Criteria:

* Subfoveal CNV secondary to AMD.
* Central retinal/lesion thickness ≥ 250µm as measured by optical coherence tomography (OCT).
* ETDRS best-corrected visual acuity of:

  * 20/40 (73 letters) or worse
* Clear ocular media and clear lens(es) to permit good quality stereoscopic fundus photography.

Exclusion Criteria:

* Prior treatment with VEGF Trap, bevacizumab or ranibizumab.
* Any investigational agent within 12 weeks of Visit 2 (Day 1).
* Presence of other causes of CNV.
* Active ocular infection.

Primary outcomes:
measure: Safety and tolerability, bioeffect
timeFrame: From baseline to Day 43
Secondary outcomes:
measure: The effect of VEGF Trap administration on excess central retinal/lesion thickness
timeFrame: From baseline to Day 43
measure: Best-corrected Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity
timeFrame: From baseline to Day 43
measure: Extent of CNV leakage
timeFrame: From baseline to Day 43
measure: Anti-VEGF Trap antibodies in the systemic circulation
timeFrame: From baseline to Day 43
measure: Plasma levels of VEGF Trap
timeFrame: From baseliene to Day 43
Other outcomes:
Locations:
city: Tuscon
country: United States
facility: Retina Centers, PC
state: Arizona
city: Loma Linda
country: United States
facility: Loma Linda University Health Care
state: California
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins Hospital School of Medicine
state: Maryland
city: Charlotte
country: United States
facility: Charlotte Eye, Ear, Nose & Throat Asssociates
state: North Carolina
city: Oklahoma City
country: United States
facility: Dean A. McGee Eye Institute
state: Oklahoma
city: Philadelphia
country: United States
facility: Retina Diagnostic and Treatment Assoc., LLC
state: Pennsylvania
city: Nashville
country: United States
facility: Retina-Vitreous Associates, P.C.
state: Tennessee
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Avner Ingerman, MD
role: STUDY_DIRECTOR
References:
citation: Nguyen QD, Campochiaro PA, Shah SM, Browning DJ, Hudson HL, Sonkin PL, Hariprasad SM, Kaiser PK, Slakter J, Haller JA, Do DV, Mieler W, Chu K, Ingerman A, Vitti R, Berliner AJ, Cedarbaum J; Clear-It 1 Investigators. Evaluation of very high- and very low-dose intravitreal aflibercept in patients with neovascular age-related macular degeneration. J Ocul Pharmacol Ther. 2012 Dec;28(6):581-8. doi: 10.1089/jop.2011.0261. Epub 2012 Jul 9.
citation: Do DV, Schmidt-Erfurth U, Gonzalez VH, Gordon CM, Tolentino M, Berliner AJ, Vitti R, Ruckert R, Sandbrink R, Stein D, Yang K, Beckmann K, Heier JS. The DA VINCI Study: phase 2 primary results of VEGF Trap-Eye in patients with diabetic macular edema. Ophthalmology. 2011 Sep;118(9):1819-26. doi: 10.1016/j.ophtha.2011.02.018. Epub 2011 May 5.