' NCT00637377 on 2008_03_17: ClinicalTrials.gov Archive
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`j Current version of this study
`- History of this study
`View of NCT00637377 on 2008_03_ 17
`
`ClinicalTrials Identifier: NCT00637377
`2008_03_ 17
`Updated:
`
`Descriptive Information
`Brief title
`
`Official title
`
`VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet
`AMO (VIEW2).
`A Randomized, Double Masked, Active Controlled, Phase 3
`Study of the Efficacy, Safety, and Tolerability of Repeated
`Doses of lntravitreal VEGF Trap in Subjects With
`Neovascular Age-Related Macular Degeneration (AMO).
`
`Brief summary
`This study is a phase Ill, 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 Europe, Asia,
`Japan, Australia and South America.
`Detailed description
`Phase
`Study type
`Study design
`Study design
`Study design
`
`Phase 3
`lnterventional
`Treatment
`Randomized
`Double Blind (Subject, Caregiver, Investigator, Outcomes
`Assessor)
`Active Control
`Parallel Assignment
`Safety/Efficacy Study
`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 (ie, prevention of moderate
`vision loss)
`Time Frame: week 52
`Safety Issue? Yes
`Measure: Mean change from baseline in BCVA as measured
`by ETDRS letter score at Week 52
`Time Frame: week 52
`Safety Issue? Yes
`Measure: The proportion of subjects who gain at least 15
`letters of vision at Week 52
`Time Frame: week 52
`Safety Issue? No
`Measure: Mean change from baseline in total NEI VFQ-25
`score at Week 52
`
`Study design
`Study design
`Study design
`Primary outcome
`
`Secondary outcome
`
`Secondary outcome
`
`Secondary outcome
`
`https://clinicaltrials.gov/archive/NCT0063 73 77 /2008 _ 03 _ 17
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`02.09.2016
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`Time Frame: week 52
`Safety Issue? No
`Secondary outcome Measure: Mean change from baseline in CNV area at Week
`52
`Time Frame: week 52
`Safety Issue? Yes
`1200 (Anticipated)
`Macular Degeneration
`Arm Label: Arm 3
`
`Enrollment
`Condition
`Arm/Group
`
`Experimental
`
`Arm/Group
`
`Arm/Group
`
`Arm/Group
`
`Intervention
`
`Intervention
`
`Intervention
`
`Intervention
`
`URL
`URL
`URL
`See also
`
`See also
`
`See also
`
`n/a
`Arm Label: Arm 1
`
`n/a
`Arm Label: Arm 2
`
`n/a
`Arm Label: Arm 4
`
`Experimental
`
`Experimental
`
`Active Comparator
`
`n/a
`Drug: VEGF Trap-Eye
`
`Arm Label: Arm 1
`
`0.5 mg VEGF Trap-Eye administered every 4 weeks during
`the first year. Thereafter a dose may be administered as
`frequently as every 4 weeks, but no less frequently than
`every 12 weeks.
`Drug: VEGF Trap-Eye
`
`Arm Label: Arm 2
`
`2.0 mg VEGF Trap-Eye administered every 4 weeks during
`the first year. Thereafter a dose may be administered as
`frequently as every 4 weeks, but no less frequently than
`every 12 weeks.
`Drug: VEGF Trap-Eye
`
`Arm Label: Arm 3
`
`2.0 mg VEGF Trap-Eye administered every 8 weeks
`(including one additional 2,0 mg dose at Week 4) during the
`first year. Thereafter a dose may be administered as
`frequently as every 4 weeks, but no less frequently than
`every 12 weeks.
`Drug: Ranibizumab
`
`Arm Label: Arm 4
`
`0.5 mg administered every 4 weeks during the first year.
`Thereafter a dose may be administered as frequently as
`every 4 weeks, but no less frequently than every 12 weeks.
`http://www.fda.gov/cder/drug/DrugSafety/Druglndex.htm
`http://www.fda.gov/medwatch/safety. htm
`http://www.clinicalstudyresults.org
`Click here and search for drug information provided by the
`FDA
`Click here and search for information on any recalls, market
`or product safety alerts by the FDA which might have
`occurred with this product
`
`https://clinicaltrials.gov/archive/NCT00637377/2008_03_17
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`02.09.2016
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`Regeneron Exhibit 2008
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`products
`
`Not yet recruiting
`2008-03
`2011-09 (Anticipated)
`
`Recruitment Information
`Status
`Start date
`Last follow-up date
`Criteria
`Inclusion Criteria:
`1. Signed informed consent.
`2. Men and women 2:: 50 years of age.
`3. Active primary or recurrent subfoveal CNV lesions secondary to AMO,
`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 at 4 meters.
`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)
`understand and willing to sign the informed consent form.
`Exclusion Criteria:
`1. Any prior ocular (in the study eye) or systemic treatment or surgery for
`neovascular AMO, except dietary supplements or vitamins.
`2. Any prior or concomitant therapy with another investigational agent to treat
`neovascular AMO in the study eye.
`3. Any prior treatment with anti-VEGF agents in the study eye.
`, including blood, scars and
`4. Total lesion size >12 disc areas (30.5 mm 2
`neovascularization) as assessed by FA in the study eye.
`5. Subretinal hemorrhages 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 by 270
`degrees by visible CNV).
`6. Scar or fibrosis making up >50% of the total lesion in the study eye.
`7. Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
`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. Prior vitrectomy in the study eye.
`12. History of retinal detachment or treatment or surgery for retinal detachment
`in the study eye.
`13. Any ·history of macular hole of stage 2 and above in the study eye.
`14. 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 it is unlikely to interfere with the injection.
`15. History or clinical evidence of diabetic retinopathy, diabetic macular edema
`or any retinal vascular disease other than AMO in either eye.
`Both
`Gender
`Minimum age
`50 Years
`Healthy volunteers
`No
`
`https://clinicaltrials.gov/archive/NCT0063 73 77 /2008 _ 03 _ l 7
`
`02.09.2016
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`· NCT00637377 on 2008_03_17: ClinicalTrials.gov Archive
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`Administrative Data
`Organization name
`Organization study ID
`Secondary ID
`Secondary ID
`Secondary ID
`Sponsor
`Collaborator
`Health Authority
`
`Bayer
`91689
`EurdaCT No.: 2007-000583-25
`311523
`VIEW2
`Bayer
`Regeneron Pharmaceuticals
`Switzerland: Ethikkommision
`
`https://clinicaltrials.gov/archive/NCT006373 77 /2008 _ 03 _17
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`02.09.2016
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`Regeneron Exhibit 2008
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