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3 Month Outcome of Ziv-aflibercept for DME

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ClinicalTrials.gov Identifier: NCT02772497
Recruitment Status : Completed
First Posted : May 13, 2016
Last Update Posted : July 6, 2017
Sponsor:
Information provided by (Responsible Party):
Ameen Marashi, Marashi Eye Clinic

Study Description
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Brief Summary:
The purpose is to show the 3-month efficacy and safety in diabetic macular edema treated with intravitreal ziv-aflibercept.

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: Ziv aflibercept Phase 2 Phase 3

Detailed Description:

Multi-studies have shown that Intravitreal aflibercept (Eylea) is effective and safe in diabetic macular edema (DME) treatment and has gained FDA approval but it is expansive where ziv aflibercept (ZALTRAP) has the same molecule but with high osmilar buffer solution which is FDA approved for colon rectus cancer treatment and it is cost effective.

Studies have shown that intravitreal ziv aflibercept is safe and nontoxic despite the high osmolarity and even has short term effect in wet age related macular degeneration.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Three-month Outcome of Ziv-aflibercept for Diabetic Macular Edema
Study Start Date : January 2016
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arms and Interventions
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Arm Intervention/treatment
Experimental: Ziv aflibercept
Intravitreal ziv aflibercept 1.25 mg (0.05ml) every 4 weeks
 Drug: Ziv aflibercept
Intravitreal ziv aflibercept 1.25 mg (0,05ml) every 4 weeks
Other Name: ZALTRAP


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of visual acuity improvement using Snellen chart or equivalent [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Amount of Central macular thickness reduction in microns after ziv-aflibercept treatment [ Time Frame: 3 months ]
  2. Amount of treatment cost in USD dollars [ Time Frame: 3 months ]
  3. Number of eyes with retinal toxicity after ziv aflibercept treatment [ Time Frame: 3 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with central diabetic macular edema
  • Best corrected visual acuity is 20/25 or less
  • Central macular thickness more than 250 microns
  • Patients who are able to come for all follow-up

Exclusion Criteria:

  • Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
  • Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization
  • For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 3 years.
  • Macular edema is present that is considered to be related to ocular surgery such as cataract extraction
  • Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more
  • History of major ocular surgery (including vitrectomy, scleral buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months following randomization.
  • Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis
Contacts and Locations
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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): NCT02772497


Sponsors and Collaborators
Marashi Eye Clinic
Investigators
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Principal Investigator: Ameen Marashi, MD Aleppo Syria
More Information
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Additional Information:

Publications of Results:
Marashi A (2016) Three-Month Outcome of Ziv-Aflibercept for Diabetic Macular Edema. Adv Ophthalmol Vis Syst 4(3): 00114. DOI: 10.15406/aovs.2016.04.00114

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Responsible Party: Ameen Marashi, MD, Marashi Eye Clinic
ClinicalTrials.gov Identifier: NCT02772497    
Other Study ID Numbers: Protocol DME1
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: July 2017
Keywords provided by Ameen Marashi, Marashi Eye Clinic:
DME
Anti VEGF
VEGF trap
Diabetes
 Diabetic retinopathy
ZALTRAP
Ziv aflibercept
Additional relevant MeSH terms:
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Macular Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases