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Novel Drug Delivery Technique Via Retroject Device

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02051946
First Posted: January 31, 2014
Last Update Posted: February 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Molly Walsh, Duke University Medical Center
  Purpose
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 Intervention Phase
Glaucoma Device: Retroject Device Drug: ethacrynic acid injection Drug: balanced salt solution Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Novel Drug Delivery Technique for Glaucoma Patients

Resource links provided by NLM:


Further study details as provided by Molly Walsh, Duke University Medical Center:

Primary Outcome Measures:
  • Change in Intraocular pressures (IOP) lowering effect [ Time Frame: 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 [ Time Frame: 6 weeks after injection ]
    Pre and post injection (6 weeks) endothelial counts will be performed for each patient.


Enrollment: 9
Study Start Date: May 2014
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02051946


Locations
United States, North Carolina
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
  More Information

Responsible Party: Molly Walsh, Assistant Professor, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT02051946     History of Changes
Other Study ID Numbers: Pro00039988
First Submitted: January 29, 2014
First Posted: January 31, 2014
Last Update Posted: February 17, 2017
Last Verified: February 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Molly Walsh, Duke University Medical Center:
novel drug delivery technique for glaucoma patients

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Pharmaceutical Solutions
Ethacrynic Acid
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action