NCT00320775

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2005

Typical duration for phase_1

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 3, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

March 18, 2015

Status Verified

March 1, 2015

Enrollment Period

3 years

First QC Date

April 28, 2006

Last Update Submit

March 16, 2015

Conditions

Macular Degeneration

Keywords

Neovascular Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability, bioeffect

    From baseline to Day 43

Secondary Outcomes (5)

  • The effect of VEGF Trap administration on excess central retinal/lesion thickness

    From baseline to Day 43

  • Best-corrected Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity

    From baseline to Day 43

  • Extent of CNV leakage

    From baseline to Day 43

  • Anti-VEGF Trap antibodies in the systemic circulation

    From baseline to Day 43

  • Plasma levels of VEGF Trap

    From baseliene to Day 43

Study Arms (3)

Part A

EXPERIMENTAL

Part A: An open label study in which six successive cohorts of 3-6 patients each with neovascular AMD will receive a single intravitreal (ITV) injection of 0.05, 0.15, 0.5, 1.0, 2.0, or 4.0 mg of VEGF Trap into the study eye. The total volume of each injection will be 100 μL. Enrollment in new dose levels will not begin until all patients in the preceding dose level have completed Visit 5 (Day 15).

Drug: VEGF Trap

Part B

ACTIVE COMPARATOR

Part B: A controlled, prospective, randomized, double-masked study in which up to 30 subjects meeting eligibility criteria will be randomly assigned in a 1:1 ratio to receive a single ITV injection of2.0 mg/eye VEGF Trap (or the MTD if reached prior to 2.0 mg) followed by 1 sham injection six weeks later, or an initial dose of 0.3 mg pegaptanib sodium into the study eye, followed by a second dose six weeks later. Enrollment into Part B will begin 2 weeks after the last subject to receive the 2.0 mg/eye dose in Part A has been observed for 15 days and it has been determined that the safety profile of VEGF Trap at this dose level is adequate to support expansion of dosing at this dose level. The dose of pegaptanib sodium will be 0.3 mg, according to the package insert.

Drug: VEGF Trap

Part C

ACTIVE COMPARATOR

Part C: A controlled, prospective, randomized, double-masked study in which approximately 30 subjects meeting eligibility criteria will be randomly assigned in a 1:1 ratio to receive up to two ITV injections of either 0.15 or 4.0 mg/eye VEGF Trap. Initiation of Part C is contingent upon the 4.0 mg dose being adequately tolerated in Part A.

Drug: VEGF Trap

Interventions

VEGF TrapDRUG

Part A: Six successive cohorts of 3-6 patients each with neovascular AMD will receive a single intravitreal (ITV) injection of 0.05, 0.15, 0.5, 1.0, 2.0, or 4.0 mg of VEGF Trap into the study eye. Part B: Up to 30 subjects will be randomly assigned in a 1:1 ratio to receive a single of 2.0 mg/eye VEGF Trap followed by 1 sham injection six weeks later, or an initial dose of 0.3 mg pegaptanib sodium into the study eye, followed by a second dose six weeks later. Part C: Approximately 30 subjects will be randomly assigned in a 1:1 ratio to receive up to two ITV injections of either 0.15 or 4.0 mg/eye VEGF Trap. After completion of Visit 8 (Day 57), patients from all parts of the study, may be eligible to continue in Open-label Extension and will receive 4.0 mg of VEGF Trap.

Also known as: Aflibercept
Part APart BPart C

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subfoveal CNV secondary to AMD.
  • Central retinal/lesion thickness ≥ 250µm as measured by optical coherence tomography (OCT).
  • ETDRS best-corrected visual acuity of:
  • /40 (73 letters) or worse
  • Clear ocular media and clear lens(es) to permit good quality stereoscopic fundus photography.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Retina Centers, PC

Tuscon, Arizona, 85704, United States

Location

Loma Linda University Health Care

Loma Linda, California, 92354, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Johns Hopkins Hospital School of Medicine

Baltimore, Maryland, 21287, United States

Location

Charlotte Eye, Ear, Nose & Throat Asssociates

Charlotte, North Carolina, 28120, United States

Location

Dean A. McGee Eye Institute

Oklahoma City, Oklahoma, 73104, United States

Location

Retina Diagnostic and Treatment Assoc., LLC

Philadelphia, Pennsylvania, 19107, United States

Location

Retina-Vitreous Associates, P.C.

Nashville, Tennessee, 37203, United States

Location

Related Publications (2)

  • 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.

    PMID: 22775078RESULT

  • 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.

    PMID: 21546089RESULT

Related Links

MeSH Terms

Conditions

Macular Degeneration

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Avner Ingerman, MD

    Regeneron Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2006

First Posted

May 3, 2006

Study Start

June 1, 2005

Primary Completion

June 1, 2008

Study Completion

August 1, 2008

Last Updated

March 18, 2015

Record last verified: 2015-03

Locations

US(8)