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Vascular Endothelial Growth Factor(VEGF)Trap-Eye:Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration(AMD) (VIEW 1)
This study is ongoing, but not recruiting participants.
Study NCT00509795   Information provided by Regeneron Pharmaceuticals
First Received: July 31, 2007   Last Updated: September 12, 2009   History of Changes

July 31, 2007
September 12, 2009
August 2007
December 2011   (final data collection date for primary outcome measure)
The proportion of subjects who maintain vision at Week 52, where a subject is classified as maintaining vision if the subject has lost fewer than 15 letters on the ETDRS chart compared to baseline (i.e. prevention of moderate vision loss) [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ]
Primary measure will be visual acuity changes compared to baseline
Complete list of historical versions of study NCT00509795 on ClinicalTrials.gov Archive Site
  • Mean change from baseline in BCVA as measured by ETDRS letter score at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ]
  • The proportion of subjects who gain at least 15 letters of vision at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Mean change from baseline in total NEI VFQ-25 score at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Mean change from baseline in CNV area at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ]
Secondary measures will be angiographic and anatomical changes compared to baseline.
 
Vascular Endothelial Growth Factor(VEGF)Trap-Eye:Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration(AMD)
A Randomized, Double Masked, Active Controlled Phase III Study of the Efficacy, Safety, and Tolerability of Repeated Doses of Intravitreal VEGF Trap in Subjects With Neovascular Age-Related Macular Degeneration

This study is a phase III, double-masked, randomized, study of the efficacy and safety of VEGF Trap-Eye in patients with neovascular age-related macular degeneration. Approximately 1200 patients will be randomized in the US and Canada.

 
Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Macular Degeneration
  • Drug: VEGF Trap-Eye
  • Drug: Ranibizumab
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
1200
December 2011
December 2011   (final data collection date for primary outcome measure)

Key Inclusion Criteria:

  1. Signed Informed Consent.
  2. Men and women ≥ 50 years of age.
  3. Active primary or recurrent subfoveal CNV lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye.
  4. ETDRS best-corrected visual acuity of: 20/40 to 20/320 (letter score of 73 to 25) in the study eye.
  5. Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures.
  6. Able to read, (or, if unable to read due to visual impairment, be read to verbatim by the person administering the informed consent or a family member. See Appendix J.4) understand and willing to sign the informed consent form.

Key Exclusion Criteria:

  1. Any prior ocular (in the study eye) or systemic treatment or surgery for neovascular AMD except dietary supplements or vitamins.
  2. Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye, except dietary supplements or vitamins.
  3. Any prior treatment with anti-VEGF agents in the study eye.
  4. Total lesion size > 12 disc areas (30.5 mm2, including blood, scars and neovascularization) as assessed by FA in the study eye.
  5. Subretinal hemorrhage that is either 50% or more of the total lesion area, or if the blood is under the fovea and is 1 or more disc areas in size in the study eye. (If the blood is under the fovea, then the fovea must be surrounded 270 degrees by visible CNV.)
  6. Scar or fibrosis, making up > 50% of total lesion in the study eye.
  7. Scar, fibrosis, or atrophy involving the center of the fovea.
  8. Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.
  9. History of any vitreous hemorrhage within 4 weeks prior to Visit 1 in the study eye.
  10. Presence of other causes of CNV in the study eye.
  11. History or clinical evidence of diabetic retinopathy, diabetic macular edema or any other vascular disease affecting the retina,other than AMD, in either eye.
  12. Prior vitrectomy in the study eye.
  13. History of retinal detachment or treatment or surgery for retinal detachment in the study eye.
  14. Any history of macular hole of stage 2 and above in the study eye.
  15. Any intraocular or periocular surgery within 3 months of Day 1 on the study eye, except lid surgery, which may not have taken place within 1 month of day 1, as long as its unlikely to interfere with the injection.
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00509795
Dr. Avner Ingerman, Regeneron Pharmaceuticals
VGFT-OD-0605
Regeneron Pharmaceuticals
Bayer
Study Director: Avner Ingerman, MD Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
September 2009

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