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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
Sponsor:
Information provided by (Responsible Party):
Ahmad Mansour, MD, Clinical Professor, AUB, Rafic Hariri University Hospital

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.


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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: intravitreal ziv-aflibercept
intravitreal ziv-aflibercept
Drug: ziv-aflibercept
zaltrap injection
Other Name: zaltrap




Primary Outcome Measures :
  1. vision before and after ziv-aflibercept [ Time Frame: 24 months ]
    EDTRS


Secondary Outcome Measures :
  1. central macular thickness before and after ziv-aflibercept [ Time Frame: 24 months ]
    Optical coherence tomography (OCT)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Ahmad M Mansour, MD 9613377633 ammansourmd@gmail.com
Contact: Muhammad H Younis, MD 9613641055 drmhy@yahoo.com

Locations
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Lebanon
Rafic Hariri University Hospital Recruiting
Beirut, Lebanon
Contact: Ahmad Mansour, MD    9613377633    ammansourmd@gmail.com   
Sub-Investigator: Muhammad Younis, MD         
Principal Investigator: Ahmad Mansour, MD         
Sponsors and Collaborators
Rafic Hariri University Hospital
Investigators
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Study Chair: Ahmad M Mansour, MD Chair, Department of Ophthalmology, RHUH

Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ahmad Mansour, MD, Clinical Professor, AUB, Chair, Department of Opthalmology, Rafic Hariri Hospital, Rafic Hariri University Hospital
ClinicalTrials.gov Identifier: NCT02486484     History of Changes
Other Study ID Numbers: RaficHaririUH
First Posted: July 1, 2015    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Three-month outcome of ziv-aflibercept for exudative age-related macular degeneration.

Mansour AM, Chhablani J, Antonios RS, Yogi R, Younis MH, Dakroub R, Chahine H. Br J Ophthalmol. 2016 Mar 30. pii: bjophthalmol-2015-308319. doi: 10.1136/bjophthalmol-2015-308319. [Epub ahead of print] PMID: 27030277

Keywords provided by Ahmad Mansour, MD, Clinical Professor, AUB, Rafic Hariri University Hospital:
macular degeneration
diabetic retinopathy
macular edema
retinal vein occlusion
choroidal neovascularization
Additional relevant MeSH terms:
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Macular Degeneration
Macular Edema
Retinal Diseases
Diabetic Retinopathy
Retinal Vein Occlusion
Choroidal Neovascularization
Pterygium
Retinal Neovascularization
Neovascularization, Pathologic
Retinal Degeneration
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Metaplasia
Pathologic Processes
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Choroid Diseases
Uveal Diseases
Conjunctival Diseases