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Novel Drug Delivery Technique Via Retroject Device

Information source: Duke University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Glaucoma

Intervention: Retroject Device only (Device); Retroject device with ethacrynic acid injection (Device); ethacrynic acid or balanced salt solution (Other)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: Molly Walsh

Official(s) and/or principal investigator(s):
Rand Allingham, MD, Principal Investigator, Affiliation: Duke University Eye Center

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.

Clinical Details

Official title: Novel Drug Delivery Technique for Glaucoma Patients

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Primary outcome: Change in Intraocular pressures (IOP) lowering effect

Eligibility

Minimum age: 55 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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)

Locations and Contacts

Duke University Eye Center, Durham, North Carolina 27710, United States; Recruiting
Rand Allingham, MD, Phone: 919-684-2975, Email: rand.allingham@dm.duke.edu
Molly Walsh, MD, Phone: 919-681-8636, Email: molly.walsh@dm.duke.edu
Molly Walsh, MD, Sub-Investigator
Stuart McKinnon, MD, Sub-Investigator
Additional Information

Starting date: May 2014
Last updated: April 30, 2015

Page last updated: August 23, 2015

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