Overview

3 Month Outcome of Ziv-aflibercept for DME

Status:
Completed
Trial end date:
2016-05-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose is to show the 3-month efficacy and safety in diabetic macular edema treated with intravitreal ziv-aflibercept.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Marashi Eye Clinic
Treatments:
Aflibercept
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