3 Month Outcome of Ziv-aflibercept for DME

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

Detailed Description
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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.

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

Conditions
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Diabetic Macular Edema

Intervention / Treatment
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* Drug: Ziv aflibercept


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ziv aflibercept<br>Intravitreal ziv aflibercept 1.25 mg (0.05ml) every 4 weeks | Drug: Ziv aflibercept<br>* Intravitreal ziv aflibercept 1.25 mg (0,05ml) every 4 weeks<br>* Other names: ZALTRAP;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DME, Anti VEGF, VEGF trap, Diabetes, Diabetic retinopathy, ZALTRAP, Ziv aflibercept