Novel Drug Delivery Technique Via Retroject Device
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|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|
|Actual Primary Completion Date :||October 2015|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|