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

NCT02173873 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2014-06-25

No results posted yet for this study

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..)

Conditions

  • Age Related Macular Degeneration
  • Central Retinal Vein Occlusion

Interventions

DRUG

ziv-aflibercept drug

intravitreal injection of ziv-ablicerpt in one eye of each patient with retinal disease and poor vision

Sponsors & Collaborators

  • Rafic Hariri University Hospital

    lead OTHER

Principal Investigators

  • Ahmad Mansour, MD · RHUH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2016-09-30
Completion
2016-12-31

Countries

  • Lebanon

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02173873 on ClinicalTrials.gov