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
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