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`History of Changes for Study: NCT00090623
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`History of Changes for Study: NCT00090623
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`A Study of rhuFab V2 (Ranibizumab) in Subjects With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular
`Degeneration (AMD)
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`Latest version (submitted June 19, 2013) on ClinicalTrials.gov
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`A study version is represented by a row in the table.
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`Select two study versions to compare. One each from columns A and B.
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`Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
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`Click "Compare" to do the comparison and show the differences.
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`Select a version's Submitted Date link to see a rendering of the study for that version.
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`The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
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`Hover over the "Recruitment Status" to see how the study's recruitment status changed.
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`Study edits or deletions are displayed in red .
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`Study additions are displayed in green .
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`Study Record Versions
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`Version
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`A
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`B
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`Submitted Date
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`Changes
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`1
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`2
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`3
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`4
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`5
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`June 23, 2005 None (earliest Version on record)
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`September 5, 2006 Recruitment Status and Study Status
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`January 30, 2007 Study Status
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`September 1, 2009 Study Status and References
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`June 19, 2013 Study Status and Sponsor/Collaborators
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`Compare
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` Comparison Format:
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` Merged
` Side-by-Side
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`Study NCT00090623
`Submitted Date: June 23, 2005 (v1)
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` Study Identification
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`Unique Protocol ID: FVF3192g
`Brief Title: A Study of rhuFab V2 (Ranibizumab) in Subjects With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration (AMD)
`
`Official Title: A Phase IIIb, Multicenter, Randomized, Double Masked, Sham Injection-Controlled Study of the Efficacy and Safety of Ranibizumab in Subjects With Subfoveal Choroidal Neovascularization (CNV) With
`or Without Classic CNV Secondary to Age Related Macular Degeneration
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`Secondary IDs:
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` Study Status
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`Record Verification: March 2005
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`Overall Status: Active, not recruiting
`Study Start: August 2004
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`Primary Completion:
`Study Completion:
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`First Submitted: August 30, 2004
`First Submitted that
`August 31, 2004
`Met QC Criteria:
`First Posted: September 1, 2004 [Estimate]
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`Last Update Submitted that
`Met QC Criteria:
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`June 23, 2005
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`Last Update Posted: June 24, 2005 [Estimate]
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` Sponsor/Collaborators
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`Sponsor: Genentech, Inc.
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`Responsible Party:
`Collaborators:
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` Oversight
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`U.S. FDA-regulated Drug:
`U.S. FDA-regulated Device:
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`Data Monitoring:
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` Study Description
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`Brief Summary: This is a phase III, multicenter, randomized, double masked, sham injection-controlled study of the efficacy and safety of intravitreally administered ranibizumab in subjects with subfoveal choroidal
`neovascularization secondary to age-related macular degeneration.
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`Detailed Description:
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`https://clinicaltrials.gov/ct2/history/NCT00090623?V_1=View#StudyPageTop
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` Conditions
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`History of Changes for Study: NCT00090623
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`Conditions: Macular Degeneration
`Keywords: Subfoveal neovascular
`Age-related macular degeneration
`AMD
`Wet AMD
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` Study Design
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`Study Type: Interventional
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`Primary Purpose: Treatment
`Study Phase: Phase 3
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`Interventional Study Model:
`Number of Arms:
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`Masking: Double (masked roles unspecified)
`Allocation: Randomized
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`Enrollment: 180
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` Arms and Interventions
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`Intervention Details:
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` Outcome Measures
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` Eligibility
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`Drug: rhuFab V2 (ranibizumab)
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`Minimum Age: 50 Years
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`Maximum Age:
`Sex: All
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`Gender Based:
`Accepts Healthy Volunteers: No
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`Criteria: Inclusion Criteria:
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`Signed informed consent
`Age >=50 years
`Active primary or recurrent subfoveal CNV lesions secondary to AMD in the study eye
`Total area of CNV (including both classic and occult components) encompassed within the lesion >= 50% of the total lesion area
`Total lesion area <=12 disc areas in size
`Best corrected visual acuity (BCVA), using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts, of 20/40 to 20/320 (Snellen equivalent) in the study eye
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`Exclusion Criteria:
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`Prior treatment with verteporfin, external-beam radiation therapy, or transpupillary thermotherapy in the study eye
`Treatment with verteporfin in the nonstudy eye <7 days preceding Day 0
`Previous participation in a clinical trial (for either eye) involving anti-angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.)
`Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye
`Previous subfoveal focal laser photocoagulation in the study eye
`Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding Day 0
`History of vitrectomy surgery in the study eye
`History of submacular surgery or other surgical intervention for AMD in the study eye
`Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals)
`Subretinal hemorrhage in the study eye that involves the center of the fovea, if the size of the hemorrhage is either >= 50% of the total lesion area or >=1 disc area in size
`Fibrosis or atrophy involving the center of the fovea in the study eye
`CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia
`Retinal pigment epithelial tear involving the macula in the study eye
`Any concurrent intraocular condition in the study eye (e.g., cataract or diabetic retinopathy) that, in the opinion of the investigator, could either: (1) Require medical or surgical intervention during the
`24-month study period to prevent or treat visual loss that might result from that condition, or (2) If allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of
`BCVA over the 24-month study period
`Active intraocular inflammation (grade trace or above) in the study eye
`Current vitreous hemorrhage in the study eye
`History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
`History of idiopathic or autoimmune-associated uveitis in either eye
`Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
`Aphakia or absence of the posterior capsule in the study eye
`Spherical equivalent of the refractive error in the study eye demonstrating more than -8 diopters of myopia
`Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding Day 0
`Uncontrolled glaucoma in the study eye (defined as intraocular pressure >=30 mmHg despite treatment with antiglaucoma medication)
`History of glaucoma filtering surgery in the study eye
`History of corneal transplant in the study eye
`Premenopausal women not using adequate contraception
`History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an
`investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications
`Current treatment for active systemic infection
`History of allergy to fluorescein, not amenable to treatment
`Inability to obtain fundus photographs or fluorescein angiograms of sufficient quality to be analyzed and graded by the central reading center
`Inability to comply with study or follow up procedures
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` Contacts/Locations
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`Locations: United States, Colorado
`Trial Information Support Line
`Denver, Colorado, United States
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` IPDSharing
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`Plan to Share IPD:
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`https://clinicaltrials.gov/ct2/history/NCT00090623?V_1=View#StudyPageTop
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` References
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`Links:
`Available IPD/Information:
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`History of Changes for Study: NCT00090623
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`Scroll up to access the controls
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`Scroll to the Study top
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`U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services
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`https://clinicaltrials.gov/ct2/history/NCT00090623?V_1=View#StudyPageTop
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