3 Month Outcome of Ziv-aflibercept for DME
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ClinicalTrials.gov Identifier: NCT02772497 |
Recruitment Status :
Completed
First Posted : May 13, 2016
Last Update Posted : July 6, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetic Macular Edema | Drug: Ziv aflibercept | Phase 2 Phase 3 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Three-month Outcome of Ziv-aflibercept for Diabetic Macular Edema |
Study Start Date : | January 2016 |
Actual Primary Completion Date : | May 2016 |
Actual Study Completion Date : | May 2016 |
Arm | Intervention/treatment |
---|---|
Experimental: Ziv aflibercept
Intravitreal ziv aflibercept 1.25 mg (0.05ml) every 4 weeks
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Drug: Ziv aflibercept
Intravitreal ziv aflibercept 1.25 mg (0,05ml) every 4 weeks
Other Name: ZALTRAP |
- Proportion of visual acuity improvement using Snellen chart or equivalent [ Time Frame: 3 months ]
- Amount of Central macular thickness reduction in microns after ziv-aflibercept treatment [ Time Frame: 3 months ]
- Amount of treatment cost in USD dollars [ Time Frame: 3 months ]
- Number of eyes with retinal toxicity after ziv aflibercept treatment [ Time Frame: 3 months ]

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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02772497
Principal Investigator: | Ameen Marashi, MD | Aleppo Syria |
Publications of Results:
Responsible Party: | Ameen Marashi, MD, Marashi Eye Clinic |
ClinicalTrials.gov Identifier: | NCT02772497 |
Other Study ID Numbers: |
Protocol DME1 |
First Posted: | May 13, 2016 Key Record Dates |
Last Update Posted: | July 6, 2017 |
Last Verified: | July 2017 |
DME Anti VEGF VEGF trap Diabetes |
Diabetic retinopathy ZALTRAP Ziv aflibercept |
Macular Edema Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases |