Novel Drug Delivery Technique Via Retroject Device

Molly Walsh

Status and phase: Completed; Phase 2; Phase 1

Conditions: Glaucoma

Treatments: Drug: ethacrynic acid injection; Drug: balanced salt solution; Device: Retroject Device

Study type: Interventional

Funder types: Other

Identifiers

NCT02051946

Pro00039988

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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9 participants in 3 patient groups

Retroject device only

Active Comparator group

Description:

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).

Treatment:

Device: Retroject Device

Retroject injection with ethacrynic acid injection

Experimental group

Description:

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.

Treatment:

Drug: ethacrynic acid injection

Device: Retroject Device

randomization to ethacrynic acid or balanced salt solution

Experimental group

Description:

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.

Treatment:

Drug: ethacrynic acid injection

Device: Retroject Device

Drug: balanced salt solution