Trial | NCT02772497  Report issue

Title

3 Month Outcome of Ziv-aflibercept for DME
Three-month Outcome of Ziv-aflibercept for Diabetic Macular Edema

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    aflibercept ...

  • Study Participants

    10
The purpose is to show the 3-month efficacy and safety in diabetic macular edema treated with intravitreal ziv-aflibercept.
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 Started
Jan 31
2016
Primary Completion
May 31
2016
Study Completion
May 31
2016
Last Update
Jul 06
2017

Drug Ziv aflibercept

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

  • Other names: ZALTRAP

Ziv aflibercept Experimental

Intravitreal ziv aflibercept 1.25 mg (0.05ml) every 4 weeks

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
No Results Posted