2/4/22, 3:54 PM
`
`Safety and Efficacy of Repeated Intravitreal Administration of Vascular Endothelial Growth Factor (VEGF) Trap in Patients With We…
`
`Try the modernized ClinicalTrials.gov beta website. Learn more about the
`modernization effort.
`
`Safety and Efficacy of Repeated Intravitreal Administration of Vascular Endothelial
`Growth Factor (VEGF) Trap in Patients With Wet Age-Related Macular Degeneration
`(AMD)
`
`The safety and scientific validity of this study is the responsibility of the study sponsor
`and investigators. Listing a study does not mean it has been evaluated by the U.S.
`Federal Government. Read our disclaimer for details.
`
`
`ClinicalTrials.gov Identifier: NCT00320788
`
`Recruitment Status : Completed
`First Posted : May 3, 2006
`Results First Posted : March 1, 2012
`Last Update Posted : March 1, 2012
`
`Sponsor:
`Regeneron Pharmaceuticals
`
`Collaborator:
`Bayer
`
`Information provided by (Responsible Party):
`Regeneron Pharmaceuticals
`
`Study Details
`
`Tabular View
`
`Study Results
`
`Disclaimer
`
`How to Read a Study Record
`
`Study Description
`
`Go to
`
`https://clinicaltrials.gov/ct2/show/NCT00320788
`
`1/8
`
`Exhibit 2101
`Page 01 of 08
`
`
`
`Safety and Efficacy of Repeated Intravitreal Administration of Vascular Endothelial Growth Factor (VEGF) Trap in Patients With We…
`
`Try the modernized ClinicalTrials.gov beta website. Learn more about the
`modernization effort.
`
`Safety and Efficacy of Repeated Intravitreal Administration of Vascular Endothelial
`Growth Factor (VEGF) Trap in Patients With Wet Age-Related Macular Degeneration
`(AMD)
`
`The safety and scientific validity of this study is the responsibility of the study sponsor
`and investigators. Listing a study does not mean it has been evaluated by the U.S.
`Federal Government. Read our disclaimer for details.
`
`
`ClinicalTrials.gov Identifier: NCT00320788
`
`Recruitment Status : Completed
`First Posted : May 3, 2006
`Results First Posted : March 1, 2012
`Last Update Posted : March 1, 2012
`
`Sponsor:
`Regeneron Pharmaceuticals
`
`Collaborator:
`Bayer
`
`Information provided by (Responsible Party):
`Regeneron Pharmaceuticals
`
`Study Details
`
`Tabular View
`
`Study Results
`
`Disclaimer
`
`How to Read a Study Record
`
`Study Description
`
`Go to
`
`https://clinicaltrials.gov/ct2/show/NCT00320788
`
`1/8
`
`Exhibit 2101
`Page 01 of 08
`
`
`
`2/4/22, 3:54 PM
`Brief Summary:
`
`Safety and Efficacy of Repeated Intravitreal Administration of Vascular Endothelial Growth Factor (VEGF) Trap in Patients With We…
`
`This study examines the effect of intravitreally administered VEGF Trap in patients with wet AMD.
`
`The purpose of this trial is to assess the ocular and systemic safety and tolerability of repeated intravitreal
`doses of VEGF Trap in patients with subfoveal choroidal neovascularization (CNV) due to AMD.
`
`Condition or disease
`
`
`Intervention/treatment
`
`Macular
`Degeneration
`
`Biological: aflibercept injection (VEGF Trap-Eye,
`BAY86-5321)
`
`Phase
`
`
`Phase 2
`
`Detailed Description:
`
`This is a double masked, prospective, randomized study in which five groups of approximately 30 patients
`meeting the eligibility criteria will be randomly assigned in a balanced ratio to receive a series of intravitreal
`(IVT) injections of VEGF Trap into the study eye at 4- or 12 -week intervals over a 12-week period.
`
`After Week 12, patients will be evaluated every 4 weeks. Patients will remain on study or may be eligible to
`enter a long-term extension study, in which they will continue to receive VEGF Trap.
`
`Study Design
`
`Go to
`
`Study Type :
`Interventional (Clinical Trial)
`Actual Enrollment :
`159 participants
`Allocation:
`Randomized
`Intervention Model:
`Parallel Assignment
`Masking:
`Triple (Participant, Care Provider, Investigator)
`Primary Purpose:
`Treatment
`Official Title:
`A Randomized, Controlled Study of the Safety, Tolerability and Biological Effect of Repeated Intravitreal
`Administration of VEGF Trap in Patients With Neovascular Age-Related Macular Degeneration
`Study Start Date :
`April 2006
`
`https://clinicaltrials.gov/ct2/show/NCT00320788
`
`2/8
`
`Exhibit 2101
`Page 02 of 08
`
`
`
`2/4/22, 3:54 PM
`
`Safety and Efficacy of Repeated Intravitreal Administration of Vascular Endothelial Growth Factor (VEGF) Trap in Patients With We…
`
`Actual Primary Completion Date :
`June 2008
`Actual Study Completion Date :
`August 2008
`
`Resource links provided by the National Library of Medicine
`
`MedlinePlus Genetics related topics: Age-related macular degeneration
`
`MedlinePlus related topics: Macular Degeneration
`
`Drug Information available for: Aflibercept Ziv-aflibercept
`
`U.S. FDA Resources
`
`Arms and Interventions
`
`Go to
`
`Arm
`
`Intervention/treatment
`
`Experimental: aflibercept injection (VEGF Trap-Eye,
`BAY86-5321) 0.5mg q4
`
`Experimental: aflibercept injection (VEGF Trap-Eye,
`BAY86-5321) 0.5mg q12
`
`Biological: aflibercept injection (VEGF Trap-Eye,
`BAY86-5321)
`Participants received 0.5 mg of aflibercept
`injection (VEGF Trap-Eye, BAY86-5321) at 4
`week intervals through Week 12
`Other Names:
`VEGF Trap-Eye
`BAY86-5321
`
`Biological: aflibercept injection (VEGF Trap-Eye,
`BAY86-5321)
`Participants received 0.5 mg of aflibercept
`injection (VEGF Trap-Eye, BAY86-5321) at 12
`week intervals through Week 12.
`Other Names:
`VEGF Trap-Eye
`BAY86-5321
`
`https://clinicaltrials.gov/ct2/show/NCT00320788
`
`3/8
`
`Exhibit 2101
`Page 03 of 08
`
`
`
`2/4/22, 3:54 PM
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`Safety and Efficacy of Repeated Intravitreal Administration of Vascular Endothelial Growth Factor (VEGF) Trap in Patients With We…
`
`Arm
`
`Intervention/treatment
`
`Experimental: aflibercept injection (VEGF Trap-Eye,
`BAY86-5321) 2.0mg q4
`
`Experimental: aflibercept injection (VEGF Trap-Eye,
`BAY86-5321) 2.0mg q12
`
`Experimental: aflibercept injection (VEGF Trap-Eye,
`BAY86-5321) 4.0mg q12
`
`Biological: aflibercept injection (VEGF Trap-Eye,
`BAY86-5321)
`Participants received 2.0 mg of aflibercept
`injection (VEGF Trap-Eye, BAY86-5321) at 4
`week intervals through Week 12
`Other Names:
`VEGF Trap-Eye
`BAY86-5321
`
`Biological: aflibercept injection (VEGF Trap-Eye,
`BAY86-5321)
`Participants received 2.0 mg of aflibercept
`injection (VEGF Trap-Eye, BAY86-5321) at 12
`week intervals through Week 12.
`Other Names:
`VEGF Trap-Eye
`BAY86-5321
`
`Biological: aflibercept injection (VEGF Trap-Eye,
`BAY86-5321)
`Participants received 4.0 mg of aflibercept
`injection (VEGF Trap-Eye, BAY86-5321) at 12
`week intervals through Week 12.
`Other Names:
`VEGF Trap-Eye
`BAY86-5321
`
`Outcome Measures
`
`Go to
`
`Primary Outcome Measures :
`1. Mean Change of CR/LT From Baseline at Week 12 [ Time Frame: Baseline and at Week 12 ]
`
`https://clinicaltrials.gov/ct2/show/NCT00320788
`
`4/8
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`Exhibit 2101
`Page 04 of 08
`
`
`
`Safety and Efficacy of Repeated Intravitreal Administration of Vascular Endothelial Growth Factor (VEGF) Trap in Patients With We…
`2/4/22, 3:54 PM
`CR/LT measured in micrometers (µm); lower individual values represent better outcomes.
`
`Secondary Outcome Measures :
`1. Mean Percent Change of CR/LT From Baseline at Week 12 [ Time Frame: Baseline and at Week
`12 ]
`
`CR/LT measured in micrometers (µm); a more negative percentage represents a better outcome
`
`2. Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic
`Retinopathy Study (ETDRS) From Baseline at Week 12 [ Time Frame: Baseline and at week 12 ]
`
`Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25
`(20/40 to 20/320) in the study eye; a higher score represents better functioning
`
`3. Percentage of Participants Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score
`From Baseline at Week 12 [ Time Frame: At Week 12 ]
`
`Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25
`(20/40 to 20/320) in the study eye; a higher score represents better functioning
`
`Eligibility Criteria
`
`Go to
`
`Information from the National Library of Medicine
`
`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, Learn About
`Clinical Studies.
`
`Ages Eligible for Study:
`50 Years and older (Adult, Older Adult)
`Sexes Eligible for Study:
`All
`Accepts Healthy Volunteers:
`No
`
`https://clinicaltrials.gov/ct2/show/NCT00320788
`
`5/8
`
`Exhibit 2101
`Page 05 of 08
`
`
`
`2/4/22, 3:54 PM
`Criteria
`
`Safety and Efficacy of Repeated Intravitreal Administration of Vascular Endothelial Growth Factor (VEGF) Trap in Patients With We…
`
`Inclusion Criteria:
`
`Subfoveal CNV secondary to AMD.
`Central retinal (including lesion) thickness ≥ 300 µm as measured by Optical Coherence Tomography
`(OCT).
`Early Treatment of Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity of 73 letters to 34
`letters.
`
`Exclusion Criteria:
`
`History of any vitreous hemorrhage within 4 weeks prior to Day 1.
`Aphakia.
`Significant subfoveal atrophy or scarring.
`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.
`Photodynamic therapy (PDT) within 12 weeks prior to Visit 2 (Day 1).
`Pegaptanib sodium (Macugen) within 8 weeks of Visit 2 (Day 1).
`Juxtascleral steroids or anecortave acetate within 24 weeks (6 months) prior to Visit 2 (Day 1).
`Intravitreal administration of triamcinolone acetonide or other steroids within 24 weeks prior to Visit 2
`(Day 1), unless no visible residue of drug substance can be seen in the vitreous cavity using indirect
`ophthalmoscopy.
`Prior systemic or intravitreal treatment with VEGF Trap, ranibizumab (Lucentis) or bevacizumab
`(Avastin).
`
`Presence of any other condition or laboratory abnormality, which, in the opinion of the Investigator, would
`interfere with the assessment of disease status/progression or jeopardize the patient's appropriate
`participation in this Phase II study.
`
`Contacts and Locations
`
`Go to
`
`Information from the National Library of Medicine
`
`To learn more about this study, you or your doctor may contact the study research staff using the contact
`information provided by the sponsor.
`
`Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00320788
`
`https://clinicaltrials.gov/ct2/show/NCT00320788
`
`6/8
`
`Exhibit 2101
`Page 06 of 08
`
`
`
`2/4/22, 3:54 PM
`
`Safety and Efficacy of Repeated Intravitreal Administration of Vascular Endothelial Growth Factor (VEGF) Trap in Patients With We…
`
`Locations
`
` Show 18 study locations
`
`Sponsors and Collaborators
`
`Regeneron Pharmaceuticals
`
`Bayer
`
`Investigators
`Study Director: Clinical Trial Management Regeneron Pharmaceuticals
`
`More Information
`
`Additional Information:
`
`Go to
`
`Primary endpoint results of a phase II study of vascular endothelial growth factor trap-eye in wet age-related
`macular degeneration.
`
`The 1-year results of CLEAR-IT 2, a phase 2 study of vascular endothelial growth factor trap-eye dosed as-CLEAR
`
`needed after 12-week fixed dosing.
`
`Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
`
`Li E, Donati S, Lindsley KB, Krzystolik MG, Virgili G. Treatment regimens for administration of anti-vascular
`endothelial growth factor agents for neovascular age-related macular degeneration. Cochrane Database Syst
`Rev. 2020 May 5;5:CD012208. doi: 10.1002/14651858.CD012208.pub2.
`
`Responsible Party:
`Regeneron Pharmaceuticals
`ClinicalTrials.gov Identifier:
`NCT00320788 History of Changes
`Other Study ID Numbers:
`VGFT-OD-0508
`First Posted:
`May 3, 2006 Key Record Dates
`Results First Posted:
`March 1, 2012
`
`https://clinicaltrials.gov/ct2/show/NCT00320788
`
`7/8
`
`Exhibit 2101
`Page 07 of 08
`
`
`
`2/4/22, 3:54 PM
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`Safety and Efficacy of Repeated Intravitreal Administration of Vascular Endothelial Growth Factor (VEGF) Trap in Patients With We…
`
`Last Update Posted:
`March 1, 2012
`Last Verified:
`January 2012
`
`Keywords provided by Regeneron Pharmaceuticals:
`Neovascular Age-Related Macular Degeneration
`
`Additional relevant MeSH terms:
`Macular Degeneration
`Retinal Degeneration
`Retinal Diseases
`Eye Diseases
`Aflibercept
`Angiogenesis Inhibitors
`Angiogenesis Modulating Agents
`Growth Substances
`Physiological Effects of Drugs
`Growth Inhibitors
`Antineoplastic Agents
`
`https://clinicaltrials.gov/ct2/show/NCT00320788
`
`8/8
`
`Exhibit 2101
`Page 08 of 08
`
`
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