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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

October 2, 2006
April 20, 2011
October 2006
September 2007   (final data collection date for primary outcome measure)
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 ]
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.
Complete list of historical versions of study NCT00383370 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety and Tolerability of Intravitreal VEGF Trap Formulations in Subjects With Neovacular AMD
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

To assess the safety and tolerability of repeated intravitreal (ITV) administration of VEGF Trap.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Neovascular Age Related Macular Degeneration
  • Drug: VEGF Trap
    VEGF Trap formulation 1, ITV-1
    Other Name: ITV-1
  • Biological: VEGF Trap
    VEGF Trap formulation 2 at higher concentration in Open label cohort
    Other Name: ITV-2
  • Experimental: ITV-1
    VEGF Trap formulation 1
    Intervention: Drug: VEGF Trap
  • Experimental: ITV-2
    VEGF Trap formulation 2
    Intervention: Drug: VEGF Trap
  • Experimental: ITV-2 OL
    VEGF Trap formulation 2 open label, higher concentration
    Intervention: Biological: VEGF Trap
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
July 2008
September 2007   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00383370
VGFT-OD-0603
No
Avner Ingerman, MD, Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
Not Provided
Study Director: Avner Ingerman, MD Regeneron Pharmaceutical
Regeneron Pharmaceuticals
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP