3 Month Outcome of Ziv-aflibercept for DME

Diabetic Macular Edema Clinical Trial

Official title:

Three-month Outcome of Ziv-aflibercept for Diabetic Macular Edema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02772497
• Other study ID #: Protocol DME1
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 11, 2016
• Last updated: July 3, 2017
• Start date: January 2016
• Est. completion date: May 2016

Study information

• Verified date: July 2017
• Source: Marashi Eye Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Macular Edema

Intervention

Drug:
• Ziv aflibercept
Intravitreal ziv aflibercept 1.25 mg (0,05ml) every 4 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Marashi Eye Clinic

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of visual acuity improvement using Snellen chart or equivalent		3 months
Secondary	Amount of Central macular thickness reduction in microns after ziv-aflibercept treatment		3 months
Secondary	Amount of treatment cost in USD dollars		3 months
Secondary	Number of eyes with retinal toxicity after ziv aflibercept treatment		3 months

External Links

•   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