3 Month Outcome of Ziv-aflibercept for DME

July 3, 2017 updated by: Ameen Marashi, Marashi Eye Clinic

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • ZALTRAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of visual acuity improvement using Snellen chart or equivalent
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Amount of Central macular thickness reduction in microns after ziv-aflibercept treatment
Time Frame: 3 months
3 months
Amount of treatment cost in USD dollars
Time Frame: 3 months
3 months
Number of eyes with retinal toxicity after ziv aflibercept treatment
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marashi Eye Clinic

Investigators

  • Principal Investigator: Ameen Marashi, MD, Aleppo Syria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

May 11, 2016

First Submitted That Met QC Criteria

May 12, 2016

First Posted (Estimate)

May 13, 2016

Study Record Updates

Last Update Posted (Actual)

July 6, 2017

Last Update Submitted That Met QC Criteria

July 3, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Protocol DME1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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