3 Month Outcome of Ziv-aflibercept for DME

Marashi Eye Clinic

Status and phase: Completed; Phase 3; Phase 2

Conditions: Diabetic Macular Edema

Treatments: Drug: Ziv aflibercept

Study type: Interventional

Funder types: Other

Identifiers

NCT02772497

Protocol DME1

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Ziv aflibercept

Experimental group

Description:

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

Treatment:

Drug: Ziv aflibercept