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

This study has been completed.
Sponsor:
Information provided by:
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00383370
First received: October 2, 2006
Last updated: April 20, 2011
Last verified: April 2011
  Purpose

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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00383370

Locations
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
Investigators
Study Director: Avner Ingerman, MD Regeneron Pharmaceutical
  More Information

No publications provided

Responsible Party: Avner Ingerman, MD, Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00383370     History of Changes
Other Study ID Numbers: VGFT-OD-0603
Study First Received: October 2, 2006
Last Updated: April 20, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 29, 2014