3 Month Outcome of Ziv-aflibercept for DME
Three-month Outcome of Ziv-aflibercept for Diabetic Macular Edema
1 other identifier
interventional
10
0 countries
N/A
Brief Summary
The purpose is to show the 3-month efficacy and safety in diabetic macular edema treated with intravitreal ziv-aflibercept.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2016
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 11, 2016
CompletedFirst Posted
Study publicly available on registry
May 13, 2016
CompletedJuly 6, 2017
July 1, 2017
4 months
May 11, 2016
July 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of visual acuity improvement using Snellen chart or equivalent
3 months
Secondary Outcomes (3)
Amount of Central macular thickness reduction in microns after ziv-aflibercept treatment
3 months
Amount of treatment cost in USD dollars
3 months
Number of eyes with retinal toxicity after ziv aflibercept treatment
3 months
Study Arms (1)
Ziv aflibercept
EXPERIMENTALIntravitreal ziv aflibercept 1.25 mg (0.05ml) every 4 weeks
Interventions
Intravitreal ziv aflibercept 1.25 mg (0,05ml) every 4 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related 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
RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ameen Marashi, MD
Aleppo Syria
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
May 11, 2016
First Posted
May 13, 2016
Study Start
January 1, 2016
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
July 6, 2017
Record last verified: 2017-07