Novel Drug Delivery Technique Via Retroject Device
|ClinicalTrials.gov Identifier: NCT02051946|
Recruitment Status : Completed
First Posted : January 31, 2014
Last Update Posted : February 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Glaucoma||Device: Retroject Device Drug: ethacrynic acid injection Drug: balanced salt solution||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Novel Drug Delivery Technique for Glaucoma Patients|
|Study Start Date :||May 2014|
|Primary Completion Date :||October 2015|
|Study Completion Date :||October 2015|
Active Comparator: Retroject device only
The first 5 patients enrolled will serve as controls and will have the device alone placed on the eye (without an injection of ethacrynic acid).
|Device: Retroject Device|
Experimental: Retroject injection with ethacrynic acid injection
The next 3 patients, after the first 5 controls, will have the device placed on the eye with a subsequent injection of ethacrynic acid into the episcleral vein.
|Device: Retroject Device Drug: ethacrynic acid injection|
Experimental: randomization to ethacrynic acid or balanced salt solution
The last 12 patients will all have the device placed on their eye. They will then be randomized in a 2:1 ratio to receive either an injection of ethacrynic acid or balanced salt solution.
|Device: Retroject Device Drug: ethacrynic acid injection Drug: balanced salt solution|
- Change in Intraocular pressures (IOP) lowering effect [ Time Frame: Days 1, 2, 3, and 7, and 6 weeks after injection ]The patients will then return for intraocular pressure measurements on days 1, 2, 3, and 7 as well as 6 weeks after injection. Differences in baseline IOP versus post-injection IOP will be calculated for each patient.
- Corneal endothelial cell counts [ Time Frame: 6 weeks after injection ]Pre and post injection (6 weeks) endothelial counts will be performed for each patient.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02051946
|United States, North Carolina|
|Duke University Eye Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Rand Allingham, MD||Duke University Eye Center|