Ziv-aflibercept in Ocular Disease Requiring Anti-VEGF Injection

NCT02486484 | Unknown Phase 2 DMC

• 1 other identifier: RaficHaririUH
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neovascularization; Macular Degeneration; Diabetic Retinopathy; Retinal Vein Occlusion; Choroidal Neovascularization; Retinal Neovascularization; Recurrent Pterygium; Cystoid Macular Edema

Keywords

macular degeneration; diabetic retinopathy; macular edema; retinal vein occlusion; choroidal neovascularization

Outcome Measures

Primary Outcomes (1)

• vision before and after ziv-aflibercept

  EDTRS

  24 months

Secondary Outcomes (1)

• central macular thickness before and after ziv-aflibercept

  24 months

Study Arms (1)

intravitreal ziv-aflibercept

EXPERIMENTAL

intravitreal ziv-aflibercept

Drug: ziv-aflibercept

Interventions

ziv-aflibercept DRUG

zaltrap injection

Also known as: zaltrap

intravitreal ziv-aflibercept

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All eye conditions that require anti-VEGF therapy
• Ability to understand and sign consent form
• Ability to come for all follow-ups (2 year followup)
• Acute form of the disease only in naïve cases

You may not qualify if:

• Cardiovascular, cerebrovascular or peripheral vascular event less than 3 months prior to enrollment
• Current infection in the eye such as conjunctivitis or keratitis
• Current upper respiratory tract infection
• Fever or active body infection
• Life-threatening disease with short survival
• late presentation of the disease (chronic end stage disease of the eye)
• Inability to sign informed consent
• Inability to come for followups

Sponsors & Collaborators

• Rafic Hariri University Hospital: lead

Study Sites (1)

Rafic Hariri University Hospital

Beirut, Lebanon

RECRUITING

Related Publications (5)

• de Oliveira Dias JR, Xavier CO, Maia A, de Moraes NS, Meyer C, Farah ME, Rodrigues EB. Intravitreal injection of ziv-aflibercept in patient with refractory age-related macular degeneration. Ophthalmic Surg Lasers Imaging Retina. 2015 Jan;46(1):91-4. doi: 10.3928/23258160-20150101-17.

  PMID: 25559518 BACKGROUND

• 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.

  PMID: 25677668 RESULT

• Mansour AM, Chhablani J, Antonios RS, Yogi R, Younis MH, Dakroub R, Chahine H. Three-month outcome of ziv-aflibercept for exudative age-related macular degeneration. Br J Ophthalmol. 2016 Dec;100(12):1629-1633. doi: 10.1136/bjophthalmol-2015-308319. Epub 2016 Mar 30.

  PMID: 27030277 RESULT

• Mansour AM, Ashraf M, El Jawhari KM, Farah M, Souka A, Sarvaiya C, Singh SR, Banker A, Chhablani J. Intravitreal ziv-aflibercept in diabetic vitreous hemorrhage. Int J Retina Vitreous. 2020 Jan 14;6:2. doi: 10.1186/s40942-019-0204-9. eCollection 2020.

  PMID: 31956432 DERIVED

• Mansour AM. Regression of Inflamed Pterygia by Frequent High-Dose Intralesional Ziv-Aflibercept. Cornea. 2017 Aug;36(8):1002-1005. doi: 10.1097/ICO.0000000000001251.

  PMID: 28614154 DERIVED

Related Links

• ziv-aflibercept in macular disease

MeSH Terms

Conditions

Neovascularization, Pathologic; Macular Degeneration; Diabetic Retinopathy; Retinal Vein Occlusion; Choroidal Neovascularization; Retinal Neovascularization; Pterygium; Macular Edema

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Retinal Degeneration; Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Choroid Diseases; Uveal Diseases; Conjunctival Diseases

Study Officials

• Ahmad M Mansour, MD

  Chair, Department of Ophthalmology, RHUH

  STUDY CHAIR

Central Study Contacts

Ahmad M Mansour, MD

CONTACT

9613377633; ammansourmd@gmail.com

Muhammad H Younis, MD

CONTACT

9613641055; drmhy@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Department of Opthalmology, Rafic Hariri Hospital

Study Record Dates

• First Submitted: May 24, 2015
• First Posted: July 1, 2015
• Study Start: March 1, 2015
• Primary Completion: May 1, 2019
• Study Completion: December 1, 2019
• Last Updated: August 29, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share

Locations

LE (1)