Novel Drug Delivery Technique Via Retroject Device

Sponsor

Molly Walsh (Other)

Overall Status

Completed

CT.gov ID

NCT02051946

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Device: Retroject Device Drug: ethacrynic acid injection Drug: balanced salt solution	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

9 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Other

Official Title:

Novel Drug Delivery Technique for Glaucoma Patients

Study Start Date :

May 1, 2014

Actual Primary Completion Date :

Oct 1, 2015

Actual Study Completion Date :

Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Change in Intraocular pressures (IOP) lowering effect [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.

Other Outcome Measures

Corneal endothelial cell counts [6 weeks after injection]
Pre and post injection (6 weeks) endothelial counts will be performed for each patient.

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University Eye Center	Durham	North Carolina	United States	27710

Sponsors and Collaborators

Molly Walsh

Investigators

Principal Investigator: Rand Allingham, MD, Duke University Eye Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Molly Walsh, Assistant Professor, Duke University

ClinicalTrials.gov Identifier:

NCT02051946

Other Study ID Numbers:

Pro00039988

First Posted:

Jan 31, 2014

Last Update Posted:

Feb 17, 2017

Last Verified:

Feb 1, 2017

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Yes

Keywords provided by Molly Walsh, Assistant Professor, Duke University

novel drug delivery technique for glaucoma patients

Additional relevant MeSH terms:

Glaucoma

Ethacrynic Acid

Study Results

No Results Posted as of Feb 17, 2017