Ziv-aflibercept in Eyes With Retinal Diseases and Poor Vision-phase I
NCT ID: NCT02173873
Last Updated: 2014-06-25
Study Results
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Basic Information
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UNKNOWN
PHASE1
100 participants
INTERVENTIONAL
2014-06-30
2016-12-31
Brief Summary
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Detailed Description
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The safety and efficacy of Eylea in the treatment of macular edema following CRVO3,4 were assessed in 2 randomized, multicenter, double-masked, sham-controlled studies: COPERNICUS and GALILEO. A total of 358 patients were treated and evaluable for efficacy (217 with Eylea) in the two studies. In both, patients were randomly assigned in a 3:2 ratio to either 2 mg Eylea administered every 4 weeks, or sham injections (control group) administered every 4 weeks for a total of 6 injections. After 6 monthly injections, patients continued to receive Eylea treatment during weeks 24 to 52 only if they met pre-specified retreatment criteria (PRN), except for patients in the sham control group in the GALILEO study who continued to receive sham injections through week 52. In the COPERNICUS study, after 6 months, 56% of patients receiving Eylea 2 mg monthly gained at least 15 letters of BCVA from baseline, as measured by ETDRS, compared to 12% of patients receiving sham injections (p\<0.01), the primary endpoint of the study. Patients receiving Eylea 2 mg monthly gained, on average, 17.3 letters of vision compared to a mean loss of 4.0 letters with sham control injections (p\<0.01), a secondary endpoint.
Ziv-aflibercept or zaltrap6 (Sanofi-Aventis US, LLC, Bridgewater, NJ/Regeneron Pharmaceuticals, Inc, Tarrytown, NY) is FDA approved for the treatment of metastatic colorectal cancer. During Bascom Palmer Eye Institute's Angiogenesis, Exudation, and Degeneration February 2014 conference, Michel Eid Farah, João R. Dias, Fernando M. Penha, and Eduardo B. Rodrigues investigated the safety of ziv-aflibercept in vitro and in vivo. In vitro toxicity was verified using ARPE-19 cultured cells exposed to anti-angiogenic vs balanced salt solution (BSS) for 10 minutes. Viability was assessed by 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) assay, which evaluates cell viability by mitochondrial activity. No signs of cell toxicity were observed, and cell viability was similar for ziv-aflibercept, aflibercept, and BSS. For the in vivo study, they tested 1 injection of 0.05 mL ziv-aflibercept vs aflibercept in the right eyes of 18 rabbits, 9 eyes in each group. BSS was injected in the fellow eyes and served as control. After the injections, all animals were examined by funduscopy, SD-OCT), and ERG at baseline, 24 hours, and 7 days. Aqueous, vitreous, and serum samples were collected at baseline, 24 hours, and 7 days for pH and osmolarity analysis. The animals were sacrificed and the eyes were enucleated for morphologic study by light and electron microscopy. No abnormalities were found at 24 hours or 7 days after intravitreal injection of either drug when assessed by fundus exam and SD-OCT, ERG, and histology as well as transmission microscopy. There were also no changes in osmolarity in the aqueous humor or vitreous samples in any group after 24 hours and 1 week.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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one injection of ziv aflibercept intravitreal route
Intervention: Inject 0.05 ml of zaltrap into the vitreous of blind eyes with various diseases (AMD, CRVO) and monitor vision and OCT 1 day and 1 week after injection
ziv-aflibercept drug
intravitreal injection of ziv-ablicerpt in one eye of each patient with retinal disease and poor vision
Interventions
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ziv-aflibercept drug
intravitreal injection of ziv-ablicerpt in one eye of each patient with retinal disease and poor vision
Other Intervention Names
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Eligibility Criteria
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Exclusion Criteria
16 Years
95 Years
ALL
No
Sponsors
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Rafic Hariri University Hospital
OTHER
Responsible Party
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Ahmad Mansour, MD, Clinical Professor, AUB
Chair, Department of Opthalmology, Rafic Hariri Hospital
Principal Investigators
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Ahmad Mansour, MD
Role: STUDY_CHAIR
RHUH
Locations
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Rafic Hariri University Hospital
Beirut, , Lebanon
Countries
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Central Contacts
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Facility Contacts
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References
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Malik D, Tarek M, Caceres del Carpio J, Ramirez C, Boyer D, Kenney MC, Kuppermann BD. Safety profiles of anti-VEGF drugs: bevacizumab, ranibizumab, aflibercept and ziv-aflibercept on human retinal pigment epithelium cells in culture. Br J Ophthalmol. 2014 Jun;98 Suppl 1(Suppl 1):i11-16. doi: 10.1136/bjophthalmol-2014-305302.
Mansour AM, Al-Ghadban SI, Yunis MH, El-Sabban ME. Ziv-aflibercept in macular disease. Br J Ophthalmol. 2015 Aug;99(8):1055-9. doi: 10.1136/bjophthalmol-2014-306319. Epub 2015 Feb 12.
Related Links
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Safety profiles of anti-VEGF drugs: bevacizumab ... www.ncbi.nlm.nih.gov/pubmed/24836865
Other Identifiers
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INV 2014-194
Identifier Type: -
Identifier Source: org_study_id
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