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3 Month Outcome of Ziv-aflibercept for DME

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02772497
Recruitment Status : Completed
First Posted : May 13, 2016
Last Update Posted : July 6, 2017
Information provided by (Responsible Party):
Ameen Marashi, Marashi Eye Clinic

Tracking Information
First Submitted Date  ICMJE May 11, 2016
First Posted Date  ICMJE May 13, 2016
Last Update Posted Date July 6, 2017
Study Start Date  ICMJE January 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2016)
Proportion of visual acuity improvement using Snellen chart or equivalent [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2016)
  • Amount of Central macular thickness reduction in microns after ziv-aflibercept treatment [ Time Frame: 3 months ]
  • Amount of treatment cost in USD dollars [ Time Frame: 3 months ]
  • Number of eyes with retinal toxicity after ziv aflibercept treatment [ Time Frame: 3 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE 3 Month Outcome of Ziv-aflibercept for DME
Official Title  ICMJE Three-month Outcome of Ziv-aflibercept for Diabetic Macular Edema
Brief Summary The purpose is to show the 3-month efficacy and safety in diabetic macular edema treated with intravitreal ziv-aflibercept.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Macular Edema
Intervention  ICMJE Drug: Ziv aflibercept
Intravitreal ziv aflibercept 1.25 mg (0,05ml) every 4 weeks
Other Name: ZALTRAP
Study Arms  ICMJE Experimental: Ziv aflibercept
Intravitreal ziv aflibercept 1.25 mg (0.05ml) every 4 weeks
Intervention: Drug: Ziv aflibercept
Publications * 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

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 12, 2016)
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02772497
Other Study ID Numbers  ICMJE Protocol DME1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ameen Marashi, Marashi Eye Clinic
Study Sponsor  ICMJE Marashi Eye Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ameen Marashi, MD Aleppo Syria
PRS Account Marashi Eye Clinic
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP