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

Sponsor
Rafic Hariri University Hospital
Study ID
NCT02173873
Phase
PHASE1
Status
Unknown

Conditions

  • Age Related Macular Degeneration
  • Central Retinal Vein Occlusion

Eligibility Criteria

Sex
ALL
Age
16 Years - 95 Years
Healthy Volunteers
Not accepted

Interventions

  • ziv-aflibercept drug — DRUG
    intravitreal injection of ziv-ablicerpt in one eye of each patient with retinal disease and poor vision

Study Details

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..)

Key Dates

Start date
Jun 30, 2014
Status verified
Jun 2014
Primary completion
Sep 30, 2016
Completion
Dec 31, 2016

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: one injection of ziv aflibercept intravitreal route
    Intervention: 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

Primary Outcome Measure

Ziv-aflibercept in retinal diseases with poor vision: Safety monitoring by OCT and visual acuity [ Time Frame: 2 years ]

Central Contacts

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