This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Safety and Tolerability of Intravitreal VEGF Trap Formulations in Subjects With Neovacular AMD

This study has been completed.
Information provided by:
Regeneron Pharmaceuticals Identifier:
First received: October 2, 2006
Last updated: April 20, 2011
Last verified: April 2011
To assess the safety and tolerability of repeated intravitreal (ITV) administration of VEGF Trap.

Condition Intervention Phase
Neovascular Age Related Macular Degeneration Drug: VEGF Trap Biological: VEGF Trap Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Trial to Assess the Safety and Tolerability of Repeated Doses of Intravitreal Administration of Two VEGF Trap Formulations in Subjects With Neovascular Age Related Macular Degeneration

Resource links provided by NLM:

Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • The primary endpoint of the study will be safety and tolerability of the study treatment at Week 12 as assessed by ophthalmic examination and reporting of AEs. [ Time Frame: 12 weeks ]

Enrollment: 20
Study Start Date: October 2006
Study Completion Date: July 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ITV-1
VEGF Trap formulation 1
Drug: VEGF Trap
VEGF Trap formulation 1, ITV-1
Other Name: ITV-1
Experimental: ITV-2
VEGF Trap formulation 2
Drug: VEGF Trap
VEGF Trap formulation 1, ITV-1
Other Name: ITV-1
Experimental: ITV-2 OL
VEGF Trap formulation 2 open label, higher concentration
Biological: VEGF Trap
VEGF Trap formulation 2 at higher concentration in Open label cohort
Other Name: ITV-2

Detailed Description:
A double-masked study in which approximately 12 subjects will receive ITV injections of VEGF Trap every 4 weeks for a total of 3 doses. Once the subjects have received the 3 doses allowed in this study, they will be evaluated every 4 weeks for continued dosing of VEGF Trap for an additional 9 months.

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subfoveal CNV secondary to AMD.
  • Central retinal (including lesion) thickness ≥ 250 µm as measured by OCT.
  • ETDRS best-corrected visual acuity (BCVA) of 20/40 to 20/400 (73 to 20 letters)

Exclusion Criteria:

  • No prior treatment with the following in the study eye:

    • Subfoveal thermal laser therapy;
    • Submacular surgery or other surgical intervention for the treatment of AMD;
    • Extrafoveal laser coagulation treatment within 12 weeks prior to Day 1 (Visit 2);
    • PDT or ITV administration of triamcinolone acetonide or any other steroid within 12 weeks prior to Day 1 (Visit 2);
    • Pegaptanib sodium within 8 weeks of Day 1 (Visit 2);
    • Juxtascleral steroids or anecortave acetate within 180 Days (6 months) prior to Day 1 (visit 2);
    • Prior systemic or intravitreal treatment with VEGF Trap or bevacizumab;
    • Any investigational agent for the treatment of eye disease within 12 weeks of Day 1 (Visit 2)
  • History of any vitreous hemorrhage within 4 weeks prior to baseline injection visit.
  • Aphakia or pseudophakia with the absence of a posterior capsule (unless it occurred as a result of a yttrium aluminum garnet [YAG] capsulotomy).
  • Significant subfoveal atrophy or scarring.
  • Any condition or laboratory abnormality that, in the opinion of the Investigator, would interfere with the assessment of disease status/progression or jeopardize the subject's appropriate participation in this 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 identifier: NCT00383370

United States, Florida
Fort Myers, Florida, United States, 33907
United States, Kansas
Wichita, Kansas, United States, 67214
United States, Maryland
Hagerstown, Maryland, United States, 21740
United States, South Carolina
Columbia, South Carolina, United States, 29169
United States, Texas
Austin, Texas, United States, 78705
McAllen, Texas, United States, 78503
Sponsors and Collaborators
Regeneron Pharmaceuticals
Study Director: Avner Ingerman, MD Regeneron Pharmaceutical
  More Information

Responsible Party: Avner Ingerman, MD, Regeneron Pharmaceuticals Identifier: NCT00383370     History of Changes
Other Study ID Numbers: VGFT-OD-0603
Study First Received: October 2, 2006
Last Updated: April 20, 2011

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases processed this record on September 21, 2017