Overview

Ziv-aflibercept in Eyes With Retinal Diseases and Poor Vision-phase I

Status:
Unknown status

Trial end date:
2016-12-01

Target enrollment:
0

Participant gender:
All

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..)

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Rafic Hariri University Hospital

Treatments:

Aflibercept

Criteria

Inclusion Criteria: Eyes with wet age related macular degeneration, central retinal vein
occlusion or diseases that require antiVEGF especially in poor vision eyes -

Exclusion Criteria: eyes that had recent eye surgery, inability to sign consent,
blepharitis, conjunctivitis

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