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Completed

NCT Number: NCT02772497

3 Month Outcome of Ziv-aflibercept for DME

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ziv aflibercept

Drug

Intravitreal ziv aflibercept 1.25 mg (0,05ml) every 4 weeks

Other names: ZALTRAP

Primary outcomes

  1. Proportion of visual acuity improvement using Snellen chart or equivalent

    Time frame: 3 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Marashi Eye Clinic

Other

Registry information

Official study title

Three-month Outcome of Ziv-aflibercept for Diabetic Macular Edema

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 13, 2016
Registry last updated
Jul 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.