Ziv-aflibercept in Eyes With Retinal Diseases and Poor Vision-phase I
ZIV
Ziv-aflibercept in Eyes With Eyes With Retinal Diseases and Poor Vision-phase I
1 other identifier
interventional
100
1 country
1
Brief Summary
Aflibercept is FDA approved and the same molecule is available as hyperosmolar for oncology (cost 800 USD for 4ml) and isoosmolar for Ophthalmology (cost 1,770 USD for 0.05ml injection). The 4ml bottle can be fractionated to be used in 40 patients hence the 0.05 ml injection would cost 20 USD for patients. Animal studies showed the injection is safe, knowing that the rabbit vitreous volume is 3-4 times smaller than the human eye. Our pilot study is to ascertain if the approved molecule for oncology when injected in the eye is safe as it is diluted into 5ml vitreous (100 times dilution). If this is so then we can save the patient 100 times for the most efficient antiVEGF that is used for maculopathy in various diseases (AMD, DME, CRVO, etc..)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2014
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 14, 2014
CompletedFirst Posted
Study publicly available on registry
June 25, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJune 25, 2014
June 1, 2014
2.3 years
June 14, 2014
June 23, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Ziv-aflibercept in retinal diseases with poor vision: Safety monitoring by OCT and visual acuity
anterior chamber, vitreous, lens, retina exam PLUS OCT and visual acuity
2 years
OCT retinal structure
OCT, visual acuity measure, inflammation measure
2 years
Study Arms (1)
one injection of ziv aflibercept intravitreal route
EXPERIMENTALIntervention: Inject 0.05 ml of zaltrap into the vitreous of blind eyes with various diseases (AMD, CRVO) and monitor vision and OCT 1 day and 1 week after injection
Interventions
intravitreal injection of ziv-ablicerpt in one eye of each patient with retinal disease and poor vision
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rafic Hariri University Hospital
Beirut, Lebanon
Related Publications (2)
Malik D, Tarek M, Caceres del Carpio J, Ramirez C, Boyer D, Kenney MC, Kuppermann BD. Safety profiles of anti-VEGF drugs: bevacizumab, ranibizumab, aflibercept and ziv-aflibercept on human retinal pigment epithelium cells in culture. Br J Ophthalmol. 2014 Jun;98 Suppl 1(Suppl 1):i11-16. doi: 10.1136/bjophthalmol-2014-305302.
PMID: 24836865BACKGROUNDMansour AM, Al-Ghadban SI, Yunis MH, El-Sabban ME. Ziv-aflibercept in macular disease. Br J Ophthalmol. 2015 Aug;99(8):1055-9. doi: 10.1136/bjophthalmol-2014-306319. Epub 2015 Feb 12.
PMID: 25677668DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ahmad Mansour, MD
RHUH
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chair, Department of Opthalmology, Rafic Hariri Hospital
Study Record Dates
First Submitted
June 14, 2014
First Posted
June 25, 2014
Study Start
June 1, 2014
Primary Completion
September 1, 2016
Study Completion
December 1, 2016
Last Updated
June 25, 2014
Record last verified: 2014-06