Novel Drug Delivery Technique Via Retroject Device

NCT02051946 | Completed Phase 1 FDA Drug FDA Device

• 1 other identifier: Pro00039988
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Keywords

novel drug delivery technique for glaucoma patients

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Corneal endothelial cell counts

  6 weeks after injection

Study Arms (3)

Retroject device only

ACTIVE COMPARATOR

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

Retroject injection with ethacrynic acid injection

EXPERIMENTAL

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

randomization to ethacrynic acid or balanced salt solution

EXPERIMENTAL

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

Interventions

Retroject Device DEVICE

Retroject device only; Retroject injection with ethacrynic acid injection; randomization to ethacrynic acid or balanced salt solution

ethacrynic acid injection DRUG

Retroject injection with ethacrynic acid injection; randomization to ethacrynic acid or balanced salt solution

balanced salt solution DRUG

randomization to ethacrynic acid or balanced salt solution

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 55 years or older of both sexes
• IOP \>20 mmHg on maximal treatment
• \<20/200 visual acuity
• willing to sign informed consent forms

You may not qualify if:

• monocular patients with bleeding disorders
• patients on anticoagulant or antiplatelet medications
• patients who had prior laser surgeries (SLT or ALT)

Sponsors & Collaborators

• Molly Walsh: lead

Study Sites (1)

Duke University Eye Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Ethacrynic Acid; Hanks Balanced Salt Solution

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Phenoxyacetates; Glycolates; Acetates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids

Study Officials

• Rand Allingham, MD

  Duke University Eye Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 29, 2014
• First Posted: January 31, 2014
• Study Start: May 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: February 17, 2017

Record last verified: 2017-02

Locations

US (1)