Novel Drug Delivery Technique Via Retroject Device

Novel Drug Delivery Technique for Glaucoma Patients

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Device: Retroject Device; Drug: ethacrynic acid injection; Drug: balanced salt solution

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corneal endothelial cell counts	Pre and post injection (6 weeks) endothelial counts will be performed for each patient.	6 weeks after injection

Collaborators and Investigators

• Sponsor: Molly Walsh
• Investigators: Principal Investigator: Rand Allingham, MD, Duke University Eye Center

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (ACTUAL): October 1, 2015
• Study Completion (ACTUAL): October 1, 2015

Study Registration Dates

• First Submitted: January 29, 2014
• First Submitted That Met QC Criteria: January 29, 2014
• First Posted (ESTIMATE): January 31, 2014

Study Record Updates

• Last Update Posted (ACTUAL): February 17, 2017
• Last Update Submitted That Met QC Criteria: February 15, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: novel drug delivery technique for glaucoma patients
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Natriuretic Agents; Diuretics; Ethacrynic Acid
• Other Study ID Numbers: Pro00039988

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes