Ziv-aflibercept in Ocular Disease Requiring Anti-VEGF Injection (Zaltrap)
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|ClinicalTrials.gov Identifier: NCT02486484|
Recruitment Status : Recruiting
First Posted : July 1, 2015
Last Update Posted : August 29, 2018
Background/aims: Aflibercept is an approved therapy for neovascular macular degeneration (AMD), diabetic macular edema (DME), retinal vein occlusion and other retinal conditions. Ziv-aflibercept is also approved by FDA and is extremely cost-effective relative to the expensive same molecule aflibercept. In vitro and in vivo studies did not detect toxicity to the retinal pigment epithelium cells using the approved cancer protein, ziv-aflibercept. Ziv-aflibercept had no loss of anti-VEGF activity when kept at 4°C in polycarbonate syringes over 4 weeks. Similar to bevacizumab, compounded ziv-aflibercept would yield a tremendous saving compared to aflibercept or ranibizumab. Phase I studies and case reports did not report any untoward toxic effects but attested to the clinical efficacy of the medication. Our purpose is to ascertain the long-term safety and efficacy in various retinal diseases of intravitreal ziv-aflibercept.
Methods: Prospectively, consecutive patients with retinal disease that require aflibercept (AMD, DME, RVO, and others) will undergo instead the same molecule ziv-aflibercept intravitreal injection of 0.05 ml of fresh filtered ziv-aflibercept (1.25mg). Monitoring of best-corrected visual acuity, intraocular inflammation, cataract progression, and retinal structure by spectral domain OCT to be done initially, one month, 6 months, 1 year, and 2 years after injections.
Anticipated Results: Analyze signs of retinal toxicity, intraocular inflammation, or change in lens status, together with best corrected visual acuity and central foveal thickness at 1 month, 6 months, 1 year and 2 year. Anticipated Conclusions: Off label use of ziv-aflibercept improves visual acuity without ocular toxicity and offers a cheaper alternative to the same molecule aflibercept (or lucentis), especially in the third world similar to bevacizumab.
|Condition or disease||Intervention/treatment||Phase|
|Neovascularization Macular Degeneration Diabetic Retinopathy Retinal Vein Occlusion Choroidal Neovascularization Retinal Neovascularization Recurrent Pterygium Cystoid Macular Edema||Drug: ziv-aflibercept||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Ziv-aflibercept in Ocular Disease Short and Long-term Study|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: intravitreal ziv-aflibercept
Other Name: zaltrap
- vision before and after ziv-aflibercept [ Time Frame: 24 months ]EDTRS
- central macular thickness before and after ziv-aflibercept [ Time Frame: 24 months ]Optical coherence tomography (OCT)
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): NCT02486484
|Contact: Ahmad M Mansour, MDfirstname.lastname@example.org|
|Contact: Muhammad H Younis, MDemail@example.com|
|Rafic Hariri University Hospital||Recruiting|
|Contact: Ahmad Mansour, MD 9613377633 firstname.lastname@example.org|
|Sub-Investigator: Muhammad Younis, MD|
|Principal Investigator: Ahmad Mansour, MD|
|Study Chair:||Ahmad M Mansour, MD||Chair, Department of Ophthalmology, RHUH|