Clinical trial NCT02772497: 3 Month Outcome of Ziv-aflibercept for DME
Official title: Three-month Outcome of Ziv-aflibercept for Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Diabetic Macular Edema
Keywords: DME
Anti VEGF
VEGF trap
Diabetes
Diabetic retinopathy
ZALTRAP
Ziv aflibercept
Lead sponsor: Marashi Eye Clinic
Sponsor class: OTHER
First posted: 2016-05-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Proportion of visual acuity improvement using Snellen chart or equivalent
timeFrame: 3 months
Secondary outcomes:
measure: Amount of Central macular thickness reduction in microns after ziv-aflibercept treatment
timeFrame: 3 months
measure: Amount of treatment cost in USD dollars
timeFrame: 3 months
measure: Number of eyes with retinal toxicity after ziv aflibercept treatment
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Aleppo Syria
name: Ameen Marashi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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