Novel Drug Delivery Technique Via Retroject Device

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-10-31

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.

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Detailed Description

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Conditions

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Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

Retroject Device

Intervention Type DEVICE

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.

Group Type EXPERIMENTAL

Retroject Device

Intervention Type DEVICE

ethacrynic acid injection

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

Retroject Device

Intervention Type DEVICE

ethacrynic acid injection

Intervention Type DRUG

balanced salt solution

Intervention Type DRUG

Interventions

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Retroject Device

Intervention Type DEVICE

ethacrynic acid injection

Intervention Type DRUG

balanced salt solution

Intervention Type DRUG

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)

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No