12/22/2021
`
`A Study of the Efficacy and Safety of Ranibizumab Injection in Patients With Macular Edema Secondary to Branch Retinal Vein Occlusi…
`
`Try the modernized ClinicalTrials.gov beta website. Learn more about the
`modernization effort.
`
`A Study of the Efficacy and Safety of Ranibizumab Injection in Patients With
`Macular Edema Secondary to Branch Retinal Vein Occlusion (BRAVO) (BRAVO)
`
`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: NCT00486018
`
`Recruitment Status  : Completed
`First Posted  : June 13, 2007
`Results First Posted  : February 25, 2011
`Last Update Posted  : May 10, 2017
`
`Sponsor:
`Genentech, Inc.
`
`Information provided by (Responsible Party):
`Genentech, Inc.
`
`Study Details
`
`Tabular View
`
`Study Results
`
`Disclaimer
`
`How to Read a Study Record
`
`Study Description
`
`Go to
`
`Brief Summary:
`This was a Phase III, multicenter, randomized, double-masked, sham injection-controlled study of the efficacy and
`safety of intravitreal ranibizumab compared with sham injections in patients with macular edema secondary to branch
`
`https://clinicaltrials.gov/ct2/show/study/NCT00486018
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`A Study of the Efficacy and Safety of Ranibizumab Injection in Patients With Macular Edema Secondary to Branch Retinal Vein Occlusi…
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`retinal vein occlusion (BRVO); 397 patients with BRVO were enrolled at 93 investigational sites in the United States.
`The study included a treatment period (6 months) and an observation period (6 months).
`
`Condition or disease 
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`Intervention/treatment 
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`Macular Edema
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`Drug: Ranibizumab injection 0.3 mg
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`Retinal Vein Occlusion
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`Drug: Ranibizumab injection 0.5 mg
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`Phase 
`
`Phase 3
`
`Drug: Sham injection
`
`Study Design
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`Go to
`
`Study Type  :
`Interventional (Clinical Trial)
`Actual Enrollment  :
`397 participants
`Allocation:
`Randomized
`Intervention Model:
`Parallel Assignment
`Masking:
`Double (Participant, Investigator)
`Primary Purpose:
`Treatment
`Official Title:
`A Phase III, Multicenter, Randomized, Sham Injection-Controlled Study of the Efficacy and Safety of
`Ranibizumab Injection Compared With Sham in Subjects With Macular Edema Secondary to Branch Retinal
`Vein Occlusion
`Study Start Date  :
`July 2007
`Actual Primary Completion Date  :
`May 2009
`Actual Study Completion Date  :
`November 2009
`
`Resource links provided by the National Library of Medicine
`
`MedlinePlus related topics: Edema
`
`https://clinicaltrials.gov/ct2/show/study/NCT00486018
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`A Study of the Efficacy and Safety of Ranibizumab Injection in Patients With Macular Edema Secondary to Branch Retinal Vein Occlusi…
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`Drug Information available for: Ranibizumab
`
`U.S. FDA Resources
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`Arms and Interventions
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`Go to
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`Arm 
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`Intervention/treatment 
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`Sham Comparator: Sham injection
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`Experimental: Ranibizumab injection 0.3 mg
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`Experimental: Ranibizumab injection 0.5 mg
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`Drug: Sham injection
`Sham injection in a single-dose regimen given
`every month (Day 0 through the Month 5 visit), for
`a total of six sham injections.
`
`Drug: Ranibizumab injection 0.3 mg
`Ranibizumab injection 0.3 mg in a single-dose
`regimen given every month (Day 0 through the
`Month 5 visit), for a total of six injections.
`Other Name: Lucentis
`
`Drug: Ranibizumab injection 0.5 mg
`Ranibizumab injection 0.5 mg in a single-dose
`regimen given every month (Day 0 through the
`Month 5 visit), for a total of six injections.
`Other Name: Lucentis
`
`Outcome Measures
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`Go to
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`Primary Outcome Measures  :
`1. Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at 6 Months
`[ Time Frame: Baseline and 6 months ]
`
`BCVA score in the study eye was based on the Early Treatment Diabetic Retinopathy Study (ETDRS)
`visual acuity charts (number of correct letters) and assessed at a starting distance of 4 meters.
`
`Secondary Outcome Measures  :
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`A Study of the Efficacy and Safety of Ranibizumab Injection in Patients With Macular Edema Secondary to Branch Retinal Vein Occlusi…
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`1. Percentage of Participants Who Gained ≥ 15 Letters in BCVA Score at Month 6 Compared With
`Baseline [ Time Frame: Baseline and 6 months ]
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`BCVA score based on the ETDRS visual acuity charts (number of correct letters) and assessed at a
`starting distance of 4 meters.
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`2. Percentage of Participants Who Lost < 15 Letters in BCVA Score at Month 6 Compared With
`Baseline [ Time Frame: Baseline and 6 months ]
`
`BCVA score based on the ETDRS visual acuity charts (number of correct letters) and assessed at a
`starting distance of 4 meters. The percentage of subjects who lost <15 letters will be greater than
`the percentage of subjects who "gained >=15 letters" as "losing <15 letters" includes both those who
`gained >=15 letters and those who were "stable" (i.e. lost between 1 and 14 letters, had no change,
`or gained between 1 and 14 letters).
`
`3. Percentage of Participants With a Central Foveal Thickness of ≤ 250 μm at Month 6 [ Time Frame: 6
`months ]
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`A central reading center assessed all optical coherence tomography (OCT) images. Central foveal
`thickness was defined as the center point thickness.
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`4. Mean Absolute Change From Baseline in Central Foveal Thickness at Month 6
`[ Time Frame: Baseline and 6 months ]
`
`A central reading center assessed all OCT images. Central foveal thickness was defined as the
`center point thickness.
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`5. Mean Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI
`VFQ-25) Near Activities Subscale Score at Month 6 [ Time Frame: Baseline and 6 months ]
`
`The NEI VFQ-25 (v. 2000; Interviewer Format) consisted of the base set of 25 questions, plus the
`optional additional questions (where questions A3, A4, and A5 pertained to the Near Activities
`Subscale). Scores ranged from 0 to 100; a higher score represented better functioning.
`
`6. Mean Change From Baseline in the NEI VFQ-25 Distance Activities Subscale Score at Month 6
`[ Time Frame: Baseline and 6 months ]
`
`The NEI VFQ-25 (v. 2000; Interviewer Format) consisted of the base set of 25 questions, plus the
`optional additional questions (where questions A6, A7, and A8 pertained to the Distance Activities
`Subscale). Scores ranged from 0 to 100; a higher score represented better functioning.
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`A Study of the Efficacy and Safety of Ranibizumab Injection in Patients With Macular Edema Secondary to Branch Retinal Vein Occlusi…
`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:
`18 Years and older (Adult, Older Adult)
`Sexes Eligible for Study:
`All
`Accepts Healthy Volunteers:
`No
`
`Criteria
`Inclusion Criteria:
`
`Willingness to provide signed Informed Consent Form
`Age ≥ 18 years
`For sexually active women of childbearing potential, use of an appropriate form of contraception (or
`abstinence) for the duration of the study
`Ability and willingness to return for all scheduled visits and assessments
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`Ocular Inclusion Criterion (Study Eye):
`
`Foveal center-involved macular edema secondary to BRVO
`BCVA using ETDRS charts of 20/40 to 20/400 (Snellen equivalent)
`Mean central subfield thickness ≥ 250 μm on two optical coherence tomography (OCT) measurements (at
`screening [confirmed by the central reading center] and Day 0 [confirmed by the evaluating physician])
`Media clarity, pupillary dilation, and participant cooperation sufficient to obtain adequate fundus
`photographs
`
`Exclusion Criteria:
`
`History of cerebral vascular accident or myocardial infarction within 3 months prior to Day 0
`History of any anti-vascular endothelial growth factor (VEGF) treatment in fellow eye within 3 months prior
`to Day 0
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`A Study of the Efficacy and Safety of Ranibizumab Injection in Patients With Macular Edema Secondary to Branch Retinal Vein Occlusi…
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`History of any systemic anti-VEGF or pro-VEGF treatment within 6 months prior to Day 0
`History of allergy to fluorescein
`History of allergy to ranibizumab injection or related molecule
`Relevant systemic disease that may be associated with increased systemic VEGF levels (namely, all active
`malignancies); history of successfully treated malignancies is not an exclusion criterion
`Uncontrolled blood pressure
`Pregnancy or lactation
`Any condition that, in the opinion of the investigator, would preclude participation in the study (e.g., chronic
`alcoholism or drug abuse, personality disorder or use of major tranquilizers, indicated difficulty in long-term
`follow-up, and likelihood of survival of less than 1 year)
`Participation in an investigational trial within 30 days prior to Day 0 that involved treatment with any drug
`(excluding vitamins and minerals) or device that has not received regulatory approval at time of study entry
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`Ocular Exclusion Criteria (Study Eye):
`
`Prior episode of retinal vein occlusion (RVO)
`Brisk afferent pupillary defect
`History of radial optic neurotomy or sheathotomy
`History or presence of age-related macular degeneration (AMD; dry or wet form)
`History of any anti-VEGF treatment in the study eye within 3 months prior to Day 0
`History of laser photocoagulation for macular edema within 4 months prior to Day 0
`History of panretinal scatter photocoagulation or sector laser photocoagulation within 3 months prior to
`randomization or anticipated within the next 4 months following randomization
`History of intraocular corticosteroid use within 3 months prior to Day 0
`History of pars plana vitrectomy
`History of intraocular surgery (including cataract extraction, scleral buckle, etc.) within 2 months prior to
`Day 0 or anticipated within the next 7 months following Day 0
`History of yttrium-aluminum-garnet capsulotomy performed within 2 months prior to Day 0
`Previous filtration surgery in the study eye
`History of herpetic ocular infection
`History of ocular toxoplasmosis
`History of rhegmatogenous retinal detachment
`History of idiopathic central serous chorioretinopathy
`Evidence upon examination of vitreoretinal interface disease (e.g., vitreomacular traction, epiretinal
`membrane), either on clinical examination or OCT, thought to be contributing to macular edema
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`An eye that, in the investigator's opinion, would not benefit from resolution of macular edema, such as eyes
`with foveal atrophy, dense pigmentary changes, or dense subfoveal hard exudates
`Presence of an ocular condition that, in the opinion of the investigator, might affect macular edema or alter
`visual acuity during the study (e.g., uveitis or other ocular inflammatory disease, neovascular glaucoma,
`Irvine-Gass syndrome, or prior macula-off rhegmatogenous retinal detachment)
`Visually significant hemorrhage obscuring the fovea and felt to be a major contributor to reduced visual
`acuity
`Presence of a substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual
`acuity by 3 lines or more (i.e., a 20/40 cataract)
`Aphakia
`Relevant ocular disease that may be associated with increased intraocular VEGF levels (namely, uveitis,
`neovascular glaucoma, neovascular AMD, diabetic retinopathy, diabetic maculopathy, or ocular ischemic
`syndrome)
`Improvement of > 10 letters on best corrected visual acuity (BCVA) between screening and Day 0
`
`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): NCT00486018
`
`Sponsors and Collaborators
`Genentech, Inc.
`
`Investigators
`Study Director: Roman Rubio, M.D. Genentech, Inc.
`
`More Information
`
`Go to
`
`Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
`
`Suñer IJ, Bressler NM, Varma R, Lee P, Dolan CM, Ward J, Colman S, Rubio RG. Reading speed
`improvements in retinal vein occlusion after ranibizumab treatment. JAMA Ophthalmol. 2013 Jul;131(7):851-6.
`doi: 10.1001/jamaophthalmol.2013.114.
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`Bhisitkul RB, Campochiaro PA, Shapiro H, Rubio RG. Predictive value in retinal vein occlusions of early versus
`late or incomplete ranibizumab response defined by optical coherence tomography. Ophthalmology. 2013
`May;120(5):1057-63. doi: 10.1016/j.ophtha.2012.11.011. Epub 2013 Feb 14.
`
`Responsible Party:
`Genentech, Inc.
`ClinicalTrials.gov Identifier:
`NCT00486018 History of Changes
`Other Study ID Numbers:
`FVF4165g
`First Posted:
`June 13, 2007 Key Record Dates
`Results First Posted:
`February 25, 2011
`Last Update Posted:
`May 10, 2017
`Last Verified:
`April 2017
`
`Keywords provided by Genentech, Inc.:
`Lucentis
`RVO
`BRVO
`Edema
`
`Additional relevant MeSH terms:
`
`https://clinicaltrials.gov/ct2/show/study/NCT00486018
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`A Study of the Efficacy and Safety of Ranibizumab Injection in Patients With Macular Edema Secondary to Branch Retinal Vein Occlusi…
`12/22/2021
`Macular Edema
`Retinal Vein Occlusion
`Edema
`Macular Degeneration
`Retinal Degeneration
`Retinal Diseases
`Eye Diseases
`Venous Thrombosis
`Thrombosis
`Embolism and Thrombosis
`Vascular Diseases
`Cardiovascular Diseases
`Ranibizumab
`Angiogenesis Inhibitors
`Angiogenesis Modulating Agents
`Growth Substances
`Physiological Effects of Drugs
`Growth Inhibitors
`Antineoplastic Agents
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