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Double-Masked Study of Efficacy and Safety of IVT VEGF Trap-Eye in Subjects With Wet AMD (VIEW 1)

This study is currently recruiting participants.
Verified by Regeneron Pharmaceuticals, June 2008

Sponsors and Collaborators: Regeneron Pharmaceuticals
Bayer
Information provided by: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00509795
  Purpose

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.


Condition Intervention Phase
Neovascular Age-Related Macular Degeneration
Biological: VEGF Trap-Eye
Drug: Comparator
Phase III

Genetics Home Reference related topics:   X-linked juvenile retinoschisis   

MedlinePlus related topics:   Macular Degeneration   

Drug Information available for:   Aflibercept   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   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

Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Primary measure will be visual acuity changes compared to baseline.

Secondary Outcome Measures:
  • Secondary measures will be angiographic and anatomical changes compared to baseline.

Estimated Enrollment:   1200
Study Start Date:   August 2007

Arms Assigned Interventions
1: Experimental Biological: VEGF Trap-Eye
2: Experimental Biological: VEGF Trap-Eye
3: Experimental Biological: VEGF Trap-Eye
4: Active Comparator Drug: Comparator

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

Criteria

Key Inclusion Criteria:

  1. Signed Informed Consent.
  2. Men and women ≥ 50 years of age.
  3. Active primary subfoveal CNV lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye.
  4. CNV must be at least 50% of total lesion size.
  5. ETDRS best-corrected visual acuity of: 20/40 to 20/320 (letter score of 73 to 25) in the study eye.
  6. Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures.
  7. 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. Prior treatment with anti-VEGF agents as follows:

    • Prior treatment with anti-VEGF therapy in the study eye is not allowed.
    • Prior treatment with anti-VEGF therapy in the fellow eye with an investigational agent (not FDA approved, e.g. bevacizumab) is allowed up to 3 months prior to first dose in the study, and such treatment will not be allowed during the study. Prior treatment with an FDA/Health Canada approved anti-VEGF therapy in the fellow eye is allowed.
    • Prior systemic anti-VEGF therapy, investigational or FDA/Health Canada approved, is only allowed up to 3 months prior to first dose, and will not be allowed during the study
  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, including pathologic myopia (spherical equivalent of -8 diopters or more negative, or axial length of 25 mm or more), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis 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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00509795

Contacts
Contact: Regeneron     866-549-8439     VIEW1study@rtp.ppdi.com    

Show 180 study locations  Show 180 Study Locations

Sponsors and Collaborators
Regeneron Pharmaceuticals
Bayer

Investigators
Study Director:     Avner Ingerman, MD     Regeneron Pharmaceuticals    
  More Information


Study ID Numbers:   VGFT-OD-0605
First Received:   July 31, 2007
Last Updated:   June 26, 2008
ClinicalTrials.gov Identifier:   NCT00509795
Health Authority:   United States: Food and Drug Administration;   Canada: Health Canada

Study placed in the following topic categories:
Eye Diseases
Retinal Degeneration
Macular Degeneration
Retinal Diseases
Retinal degeneration

ClinicalTrials.gov processed this record on November 30, 2008




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