Ziv-aflibercept in Ocular Disease Requiring Anti-VEGF Injection

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rafic Hariri University Hospital
• Treatments: Aflibercept

Criteria

Inclusion Criteria: All conditions that require anti-VEGF therapy

1. All eye conditions that require anti-VEGF therapy

2. Ability to understand and sign consent form

3. Ability to come for all follow-ups (2 year followup)

4. Acute form of the disease only in naïve cases

Exclusion Criteria:

1. Cardiovascular, cerebrovascular or peripheral vascular event less than 3 months prior to enrollment

2. Current infection in the eye such as conjunctivitis or keratitis

3. Current upper respiratory tract infection

4. Fever or active body infection

5. Life-threatening disease with short survival

6. late presentation of the disease (chronic end stage disease of the eye)

7. Inability to sign informed consent

8. Inability to come for followups