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