Novel Drug Delivery Technique Via Retroject Device

Study Overview
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Brief Summary
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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.

Official Title
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Novel Drug Delivery Technique for Glaucoma Patients

Conditions
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Glaucoma

Intervention / Treatment
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* Device: Retroject Device
* Drug: ethacrynic acid injection
* Drug: balanced salt solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 55 years or older of both sexes IOP >20 mmHg on maximal treatment <20/200 visual acuity willing to sign informed consent forms Exclusion Criteria: monocular patients with bleeding disorders patients on anticoagulant or antiplatelet medications patients who had prior laser surgeries (SLT or ALT)

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Retroject device only<br>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<br> <br> |
| Experimental: Retroject injection with ethacrynic acid injection<br>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<br> <br> Drug: ethacrynic acid injection<br> <br> |
| Experimental: randomization to ethacrynic acid or balanced salt solution<br>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<br> <br> Drug: ethacrynic acid injection<br> <br> Drug: balanced salt solution<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Intraocular pressures (IOP) lowering effect | 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. | Days 1, 2, 3, and 7, and 6 weeks after injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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novel drug delivery technique for glaucoma patients