In this open label phase I/II trial two out of five participants (40%) met the criteria for treatment success as defined by the study protocol (with at least a 25% decrease in central thickness as measured on OCT at Week 1).Participants presented with overall mean decreases in excess central thickness of 13% (ranging from a 102% decrease to a 54% increase) and 10% (ranging from 106% decrease to a 108% increase) in their study eyes at Weeks 1 and 2, respectively.No adverse events have been reported under this IND during the reporting period.Changes in study eye visual acuity (Early Treatment Diabetic Retinopathy Study ETDRS total letters read) ranged from a decrease of 7 letters to an increase of 6 letters read from baseline at Week 1 (mean increase of 0.20 letters read) and ranged from a decrease of 10 letters to an increase in 13 letters read from baseline at Week 2 (mean increase of 4 letters read). Changes in fellow eye visual acuity ranged from a decrease of 1 letter to an increase of 10 letters read at Week 1 (mean increase of 1.60 letters read) and ranged from a decrease of 2 letters to an increase of 15 letters read at Week 2 (mean of 3.2 letters read). Changes in study eye IOP ranged from -2 mmHg to 3 mmHg (mean change of 0.40 mmHg) at Week 1 and ranged from -1 mmHg to 2 mmHg (mean change of 0.40 mmHg) at Week 2. Changes in fellow eye IOP ranged from -14 mmHg to 3 mmHg (mean change of -1.60 mmHg) at Week 1 and ranged from -15 mmHg to 4 mmHg (mean change of -2.20 mmHg) at Week 2.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Investigator-Initiated Intramural Research Projects (ZIA)
Project #
1ZIAEY000518-01
Application #
8556880
Study Section
Project Start
Project End
Budget Start
Budget End
Support Year
1
Fiscal Year
2012
Total Cost
$2,435
Indirect Cost
Name
U.S. National Eye Institute
Department
Type
DUNS #
City
State
Country
Zip Code