3/13/23, 9:28 PM
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`History of Changes for Study: NCT00685854
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`History of Changes for Study: NCT00685854
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`Pilot Study of Intravitreal Injection of Ranibizumab for Macular Telangiectasia With Neovascularization (MACTEL 2)
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`Latest version (submitted June 30, 2017) on ClinicalTrials.gov
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`A study version is represented by a row in the table.
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`Click "Compare" to do the comparison and show the differences.
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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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`B
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`Changes
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`May 24, 2008 None (earliest Version on record)
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`June 18, 2008 Study Status
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`June 24, 2008 Study Description, Study Status and Study Identification
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`July 16, 2008 References and Study Status
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`July 18, 2008 Study Status
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`March 18, 2009 Study Status
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`June 9, 2009 Study Status
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`August 24, 2009 Study Status
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`November 25, 2009 Study Design and Study Status
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`March 13, 2010 Study Status
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`June 16, 2010 Study Status
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`July 7, 2010 Study Status
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`August 20, 2010 Study Status
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`September 17, 2010 References and Study Status
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`December 10, 2010 Recruitment Status, Study Status, Contacts/Locations, Study Design and References
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`December 14, 2010 Study Description and Study Status
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`December 22, 2010 Study Status
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`March 30, 2011 Recruitment Status, Study Status and References
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`September 26, 2015 Study Status
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`January 19, 2017 Study Status
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`January 20, 2017 Study Status
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`January 24, 2017 Study Status
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`June 30, 2017 Study Status
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`Compare
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`Study NCT00685854
`Submitted Date: May 24, 2008 (v1)
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` Study Identification
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`Unique Protocol ID: 080147
`Brief Title: Pilot Study of Intravitreal Injection of Ranibizumab for Macular Telangiectasia With Neovascularization (MACTEL 2)
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`Official Title: Pilot Study of Intravitreal Injection of Ranibizumab for Macular Telangiectasia Without Neovascularization (MACTEL 2)
`Secondary IDs: 08-EI-0147
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` Study Status
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`Record Verification: April 2008
`Overall Status: Recruiting
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`Study Start: May 2008
`Primary Completion:
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`Study Completion:
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`First Submitted: May 24, 2008
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`First Submitted that
`Met QC Criteria:
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`May 24, 2008
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`https://clinicaltrials.gov/ct2/history/NCT00685854?V_1=View#StudyPageTop
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`3/13/23, 9:28 PM
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`History of Changes for Study: NCT00685854
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`First Posted: May 28, 2008 [Estimate]
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`Last Update Submitted that
`Met QC Criteria:
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`May 24, 2008
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`Last Update Posted: May 28, 2008 [Estimate]
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` Sponsor/Collaborators
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`Sponsor: National Eye Institute (NEI)
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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: Retinal telangiectasis is a group of rare, idiopathic retinal vascular anomalies affecting the retinal capillaries in which irregular capillary dilation and incompetence occur in the macula. This is the group 2
`in the Gass classification of idiopathic juxtafoveal telangiectasia in which fluorescein angiography showed leakage with capillary dilation. These patients typically are diagnosed in their fifth or sixth decade
`of life. Both sexes may be affected. Minimal exudation, superficial retinal crystalline deposits, and right-angle venules characterize this disorder. The pathogenesis of the disease is unknown. Because of
`the leakage of the retinal vessels and also the finding of neovascularization, it is possible that vascular endothelial growth factor (VEGF) may be implicated in this disease.
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`The purpose of this study is to evaluate the possible role of ranibizumab for the treatment of eight participants with macular telangiectasia with hyperfluorescence on fluorescein angiography, with vision
`better than 20/400, without neovascularization. The primary outcome of this study will be the proportion of participants that lose 15 letters or more in ETDRS BCVA at 12 months compared with baseline.
`The secondary outcomes measured at one year will include the proportion of participants who lose 10 letters or more, the mean change in ETDRS BCVA, the change in central retinal thickness, the
`extent of fluorescein leakage, the change in fundus autofluorescence, change in size of neovascular membrane and the change in central retinal sensitivity. This is a pilot study designed to evaluate the
`feasibility and potential efficacy of treating patients with macular telangiectasia in a larger, phase III study within the organization of the MAC TEL Research Group, sponsored by the Lowy Foundation.
`Currently, the research group is enrolling 200 patients affected with this condition for a natural history study in 22 international clinical centers.
`
`Detailed Description: Retinal telangiectasis is a group of rare, idiopathic retinal vascular anomalies affecting the retinal capillaries in which irregular capillary dilation and incompetence occur in the macula. This is the group 2
`in the Gass classification of idiopathic juxtafoveal telangiectasia in which fluorescein angiography showed leakage with capillary dilation. These patients typically are diagnosed in their fifth or sixth decade
`of life. Both sexes may be affected. Minimal exudation, superficial retinal crystalline deposits, and right-angle venules characterize this disorder. The pathogenesis of the disease is unknown. Because of
`the leakage of the retinal vessels and also the finding of neovascularization, it is possible that vascular endothelial growth factor (VEGF) may be implicated in this disease.
`
`The purpose of this study is to evaluate the possible role of ranibizumab for the treatment of eight participants with macular telangiectasia with hyperfluorescence on fluorescein angiography, with vision
`better than 20/400, without neovascularization. The primary outcome of this study will be the proportion of participants that lose 15 letters or more in ETDRS BCVA at 12 months compared with baseline.
`The secondary outcomes measured at one year will include the proportion of participants who lose 10 letters or more, the mean change in ETDRS BCVA, the change in central retinal thickness, the
`extent of fluorescein leakage, the change in fundus autofluorescence, change in size of neovascular membrane and the change in central retinal sensitivity. This is a pilot study designed to evaluate the
`feasibility and potential efficacy of treating patients with macular telangiectasia in a larger, phase III study within the organization of the MAC TEL Research Group, sponsored by the Lowy Foundation.
`Currently, the research group is enrolling 200 patients affected with this condition for a natural history study in 22 international clinical centers.
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` Conditions
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`Conditions: Macular Telangiectasia
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`Keywords: Macular Telangiectasia
`Vascular Endothelial Growth Factor
`Ranibizumab
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` Study Design
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`Study Type: Interventional
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`Primary Purpose: Treatment
`Study Phase: Phase 1
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`Interventional Study Model: Single Group Assignment
`Number of Arms:
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`Masking: None (Open Label)
`Allocation: Non-Randomized
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`Enrollment: 8
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` Arms and Interventions
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`Intervention Details:
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`Drug: Ranibizumab
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` Outcome Measures
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`Primary Outcome Measures:
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`1. Effect of intravitreal ranibizumab treatment on visual acuity
`Secondary Outcome Measures:
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`1. ETDRS BCVA, area of retinal leakage, retinal thickness, area of hypofluoresence, central retinal sensitivity
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` Eligibility
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`Minimum Age: 18 Years
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`Maximum Age:
`Sex: All
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`Gender Based:
`Accepts Healthy Volunteers: No
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`Criteria:
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`INCLUSION CRITERIA:
`Participant must understand and sign the informed consent.
`Participant must be at least 18 years of age.
`Participant must have macular telangiectasia in both eyes.
`Participant must have vision loss of better than 20/400 in the study eye.
`Participant must have clear ocular media and adequate pupillary dilation to permit good quality stereoscopic fundus photography.
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`History of Changes for Study: NCT00685854
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`All women of childbearing potential must have a negative urine pregnancy test at baseline, and be willing to undergo testing immediately prior to each injection and monthly for at least two months
`following the last dose of ranibizumab.
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`EXCLUSION CRITERIA:
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`Safety and toxicity of ranibizumab have not yet been investigated in children. Further, it is unlikely that younger participants will be able to comply with all examinations and intravitreal injections.
`Therefore, participants below the age of 18 will be excluded from participation in the study. This ocular condition is not commonly found in participants below the age of 18.
`Participant has neovascularization in either eye.
`History (within past five years) or evidence of severe cardiac disease (apparent in electrocardiogram abnormalities, clinical history of unstable angina, acute coronary syndrome, myocardial
`infarction, revascularization procedure within six months prior to baseline, atrial or ventricular tachyarrythmias requiring ongoing treatment).
`History of stroke within 12 months of study entry.
`History within the past 30 days of a chronic ocular or periocular infection (including any history of ocular herpes zoster).
`Current acute ocular or periocular infection.
`Any major surgical procedure within one month of study entry.
`Known serious allergies to fluorescein dye.
`Previous participation in a clinical trial (for either eye) involving anti-angiogenic drugs (pegaptanib, ranibizumab, bevacizumab, anecortave acetate, Protein Kinase C inhibitors, etc.).
`Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye.
`History of vitrectomy surgery in the study eye.
`History of glaucoma filtering surgery in the study eye.
`History of corneal transplant in the study eye.
`Pregnancy (positive pregnancy test) or lactation and premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization
`or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
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` Contacts/Locations
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`Central Contact Person: Patient Recruitment and Public Liaison Office
`Telephone: (800) 411-1222
`Email: prpl@mail.cc.nih.gov
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`Central Contact Backup: TTY
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`Telephone: 1-866-411-1010
`Locations: United States, Maryland
`National Institutes of Health Clinical Center, 9000 Rockville Pike
`[Recruiting]
`Bethesda, Maryland, United States, 20892
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` IPDSharing
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`Plan to Share IPD:
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` References
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`Citations: Amin R, Puklin JE, Frank RN. Growth factor localization in choroidal neovascular membranes of age-related macular degeneration. Invest Ophthalmol Vis Sci. 1994 Jul;35(8):3178-88. PubMed 7519180
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`Links: URL: http://clinicalstudies.info.nih.gov/detail/A_2008-EI-0147.html
`Description: NIH Clinical Center Detailed Web Page
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`Available IPD/Information:
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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/NCT00685854?V_1=View#StudyPageTop
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