Ziv-aflibercept in Ocular Disease Requiring Anti-VEGF Injection
Status:
Unknown status
Trial end date:
2019-12-01
Target enrollment:
Participant gender:
Summary
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.