High Dose (2.0mg) Intravitreal Ranibizumab for Recalcitrant Radiation Retinopathy
This study is an open-label, Phase I study of intravitreally administered ranibizumab in
subjects with radiation retinopathy. This is a single center, non-randomized, active
treatment study involving 10 consecutive patients. This study will evaluate the safety and
tolerability of a high dose (2.0 mg) intravitreal ranibizumab and its effect on regression
of radiation retinopathy and mean change in visual acuity.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of participants with adverse events (allergy, infection, or change in vital signs)
All subjects will be assessed at baseline, at 7 days after first injection, and monthly for adverse events. The primary outcome measures for safety and tolerability are: 1. incidence and severity of ocular adverse events, as identified by eye examination (including best corrected visual acuity testing) and 2. Incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs
Baseline, at day 7, then monthly
Yes
Paul T Finger, MD
Principal Investigator
The New York Eye Cancer Center
United States: Food and Drug Administration
FVF4981S
NCT01334879
May 2011
November 2012
Name | Location |
---|---|
The New York Eye Cancer Center | New York, New York 10021 |