Novel Drug Delivery Technique Via Retroject Device
Completed · Phase 1/Phase 2
Conditions studied: Glaucoma
In brief
The purpose of this study is to identify whether or not injection of a study drug (ethacrynic acid) using the investigational Retroject device is able to lower eye pressures in patients with advanced glaucoma. 20 patients with advanced glaucoma with visual acuity less than 20/200 and intraocular pressures (IOP) \>20mmHg on maximum medical therapy will be asked to participate in the study. The first five patients will have the Retroject device placed over their eye for 30 seconds and then removed. Assuming no issues, then it will be placed on the eye for one minute. The second group of patients (3 total) will have the Retroject device placed on the eye and then an injection of ethacrynic acid into the episcleral vein. The third group of patients (12 total) will have the Retroject device placed on the eye and then will be randomized in a 2:1 ratio to receive either an ethacrynic acid injection or a balanced salt solution injection. All 20 patients will then return for intraocular pressure measurements on days 1, 2, 3, and 7 as well as 6 weeks after injection. In addition, the patients will undergo pre and post intervention corneal endothelial assessments (endothelial cell count, shape analysis, and pachymetry). Potential safety issues are unlikely and include bleeding, infection, pain, ototoxicity, or temporary or permanent loss of vision.
Key facts
- Study ID
- NCT02051946
- Run by
- Molly Walsh
- People needed
- 9
- Starts
- 2014-05-01
- Expected to finish
- 2015-10-01
- Last updated by the study team
- 2017-02-17
Who can join
Age: 55 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- age 55 years or older of both sexes
- IOP >20 mmHg on maximal treatment
- <20/200 visual acuity
- willing to sign informed consent forms
You may not qualify if…
- monocular patients with bleeding disorders
- patients on anticoagulant or antiplatelet medications
- patients who had prior laser surgeries (SLT or ALT)
Where it is running
- Duke University Eye Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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