8/2/2021
`
`A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Lucentis® Compared to Luce…
`
`
`
`COVID-19 Information
`Public health information (CDC)
`Research information (NIH)
`SARS-CoV-2 data (NCBI)
`Prevention and treatment information (HHS)
`Español
`
`Trial record 2 of 3 for: fovista | Phase 3
`
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`
`A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous
`Administration in Combination With Lucentis® Compared to Lucentis®
`Monotherapy
`
`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: NCT01940900
`
`Recruitment Status : Terminated
`First Posted : September 12, 2013
`Results First Posted : August 15, 2018
`Last Update Posted : August 15, 2018
`
`Sponsor:
`Ophthotech Corporation
`
`Information provided by (Responsible Party):
`
`https://clinicaltrials.gov/ct2/show/NCT01940900?term=fovista&phase=2&draw=2&rank=2
`
`1/7
`
`Regeneron Exhibit 2025
`Page 01 of 07
`
`
`
`A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Lucentis® Compared to Luce…
`
`
`
`COVID-19 Information
`Public health information (CDC)
`Research information (NIH)
`SARS-CoV-2 data (NCBI)
`Prevention and treatment information (HHS)
`Español
`
`Trial record 2 of 3 for: fovista | Phase 3
`
`Previous Study | Return to List
`
` | Next Study
`
`A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous
`Administration in Combination With Lucentis® Compared to Lucentis®
`Monotherapy
`
`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: NCT01940900
`
`Recruitment Status : Terminated
`First Posted : September 12, 2013
`Results First Posted : August 15, 2018
`Last Update Posted : August 15, 2018
`
`Sponsor:
`Ophthotech Corporation
`
`Information provided by (Responsible Party):
`
`https://clinicaltrials.gov/ct2/show/NCT01940900?term=fovista&phase=2&draw=2&rank=2
`
`1/7
`
`Regeneron Exhibit 2025
`Page 01 of 07
`
`
`
`8/2/2021
`
`A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Lucentis® Compared to Luce…
`Ophthotech ( Ophthotech Corporation )
`
`Study Details
`
`Tabular View
`
`Study Results
`
`Disclaimer
`
`How to Read a Study Record
`
`Study Description
`
`Go to
`
`Brief Summary:
`The objectives of this study are to evaluate the safety and efficacy of intravitreal administration of Fovista®
`administered in combination with Lucentis® compared to Lucentis® monotherapy in subjects with subfoveal choroidal
`neovascularization secondary to age-related macular degeneration (AMD).
`
`Condition or disease
`
`Intervention/treatment
`
`Age-Related Macular Degeneration
`
`Drug: E10030
`
`Phase
`
`Phase 3
`
`Drug: ranibizumab
`
`Drug: E10030 sham intravitreal injection
`
`Detailed Description:
`
`Subjects will be randomized in a 1:1 ratio to the following dose groups:
`
`Fovista® 1.5 mg/eye + Lucentis® 0.5 mg/eye
`Fovista® sham + Lucentis® 0.5 mg/eye
`
`Subjects will be treated for a total of 24 months with active Fovista® or sham in combination with Lucentis®
`with the primary endpoint at 12 months.
`
`Primary Efficacy Endpoint:
`
`The primary efficacy endpoint is the mean change in visual acuity (ETDRS letters) from baseline at the month
`12 visit.
`
`Safety Endpoints:
`
`Safety endpoints include adverse events, vital signs, ophthalmic variables [ophthalmic examination, intraocular
`pressure (IOP), fluorescein angiogram (FA), optical coherence tomography (OCT)], ECG, and laboratory
`variables.
`
`Approximately 622 subjects will be randomized into one of the two treatment cohorts (311 patients per dose
`group).
`
`Study Design
`
`Study Type :
`Interventional (Clinical Trial)
`
`Go to
`
`https://clinicaltrials.gov/ct2/show/NCT01940900?term=fovista&phase=2&draw=2&rank=2
`
`2/7
`
`Regeneron Exhibit 2025
`Page 02 of 07
`
`
`
`8/2/2021
`
`A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Lucentis® Compared to Luce…
`
`Actual Enrollment :
`627 participants
`Allocation:
`Randomized
`Intervention Model:
`Parallel Assignment
`Masking:
`Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
`Primary Purpose:
`Treatment
`Official Title:
`A Phase 3 Randomized, Double-masked, Controlled Trial to Establish the Safety and Efficacy of
`Intravitreous Administration of Fovista® (Anti PDGF-B Pegylated Aptamer) Administered in Combination
`With Lucentis® Compared to Lucentis® Monotherapy in Subjects With Subfoveal Neovascular Age-related
`Macular Degeneration.
`Study Start Date :
`August 2013
`Actual Primary Completion Date :
`December 2016
`Actual Study Completion Date :
`December 2016
`
`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: Ranibizumab
`
`U.S. FDA Resources
`
`Arms and Interventions
`
`Go to
`
`Arm
`
`Intervention/treatment
`
`https://clinicaltrials.gov/ct2/show/NCT01940900?term=fovista&phase=2&draw=2&rank=2
`
`3/7
`
`Regeneron Exhibit 2025
`Page 03 of 07
`
`
`
`8/2/2021
`
`A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Lucentis® Compared to Luce…
`
`Arm
`
`Experimental: E10030 + ranibizumab
`E10030 1.5 mg intravitreal injection +
`ranibizumab 0.5 mg intravitreal injection
`
`Intervention/treatment
`
`Drug: E10030
`Other Name: Fovista®
`
`Drug: ranibizumab
`Other Name: Lucentis®
`
`Active Comparator: Sham + ranibizumab
`E10030 sham intravitreal injection + ranibizumab
`0.5 mg intravitreal injection
`
`Drug: ranibizumab
`Other Name: Lucentis®
`
`Drug: E10030 sham intravitreal injection
`Pressure on the eye with a syringe with no needle
`Other Name: Sham
`
`Outcome Measures
`
`Go to
`
`Primary Outcome Measures :
`1. Mean Change in Visual Acuity From Baseline to 12 Months [ Time Frame: 12 Months ]
`
`The primary efficacy endpoint is the mean change in visual acuity (ETDRS letters) from baseline to the
`month 12 visit. Higher ETDRS letters represents higher vision and a higher change in ETDRS letters
`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.
`
`https://clinicaltrials.gov/ct2/show/NCT01940900?term=fovista&phase=2&draw=2&rank=2
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`4/7
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`Regeneron Exhibit 2025
`Page 04 of 07
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`
`
`8/2/2021
`
`A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Lucentis® Compared to Luce…
`
`Ages Eligible for Study:
`50 Years and older (Adult, Older Adult)
`Sexes Eligible for Study:
`All
`Accepts Healthy Volunteers:
`No
`
`Criteria
`Inclusion Criteria:
`
`Subjects of either gender aged ≥ 50 years
`Active subfoveal choroidal neovascularization (CNV) secondary to AMD
`Presence of sub-retinal hyper-reflective material (SD-OCT)
`
`Exclusion Criteria:
`
`Any prior treatment for AMD in the study eye prior to the Day 1 visit, except oral supplements of vitamins
`and minerals
`Any prior intravitreal treatment in the study eye prior to the Day 1 visit, regardless of indication (including
`intravitreal corticosteroids)
`Any intraocular surgery or thermal laser within three (3) months of trial entry. Any prior thermal laser in the
`macular region, regardless of indication
`Subjects with subfoveal scar or subfoveal atrophy are excluded
`Diabetes mellitus
`
`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): NCT01940900
`
`Locations
`
` Show 121 study locations
`
`Sponsors and Collaborators
`
`https://clinicaltrials.gov/ct2/show/NCT01940900?term=fovista&phase=2&draw=2&rank=2
`
`5/7
`
`Regeneron Exhibit 2025
`Page 05 of 07
`
`
`
`A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Lucentis® Compared to Luce…
`8/2/2021
`Ophthotech Corporation
`
`More Information
`
`Go to
`
`Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
`
`Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019
`Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19. Review.
`
`Responsible Party:
`Ophthotech Corporation
`ClinicalTrials.gov Identifier:
`NCT01940900 History of Changes
`Other Study ID Numbers:
`OPH1003
`First Posted:
`September 12, 2013 Key Record Dates
`Results First Posted:
`August 15, 2018
`Last Update Posted:
`August 15, 2018
`Last Verified:
`August 2018
`
`Individual Participant Data (IPD) Sharing Statement:
`Plan to Share IPD:
`No
`Plan Description:
`There is no plan to share individual participant data at this time
`
`Keywords provided by Ophthotech ( Ophthotech Corporation ):
`Wet AMD
`choroidal neovascularization
`Fovista®
`E10030
`Lucentis®
`
`https://clinicaltrials.gov/ct2/show/NCT01940900?term=fovista&phase=2&draw=2&rank=2
`
`6/7
`
`Regeneron Exhibit 2025
`Page 06 of 07
`
`
`
`A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Lucentis® Compared to Luce…
`8/2/2021
`Additional relevant MeSH terms:
`Macular Degeneration
`Retinal Degeneration
`Retinal Diseases
`Eye Diseases
`Ranibizumab
`Angiogenesis Inhibitors
`Angiogenesis Modulating Agents
`Growth Substances
`Physiological Effects of Drugs
`Growth Inhibitors
`Antineoplastic Agents
`
`https://clinicaltrials.gov/ct2/show/NCT01940900?term=fovista&phase=2&draw=2&rank=2
`
`7/7
`
`Regeneron Exhibit 2025
`Page 07 of 07
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