Novel Drug Delivery Technique Via Retroject Device

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by Duke University
Sponsor:
Information provided by (Responsible Party):
Molly Walsh, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT02051946
First received: January 29, 2014
Last updated: April 23, 2014
Last verified: April 2014
  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 only
Device: Retroject device with ethacrynic acid injection
Other: ethacrynic acid or balanced salt solution
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Novel Drug Delivery Technique for Glaucoma Patients

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Change in Intraocular pressures (IOP) lowering effect [ Time Frame: Days 1, 2, 3, and 7, and 6 weeks after injection ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Pre and post injection (6 weeks) endothelial counts will be performed for each patient.


Estimated Enrollment: 20
Study Start Date: May 2014
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: December 2014 (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 only
If the patient agrees to participate in this study, the patient will be asked to lie in a supine position. Then a drop of proparacaine as well as a drop of betadine will be placed in the eye. The sterile, disposable Retroject Device will be pushed down over the eye. It will feel tight around the patient's eye for about a minute. The Retroject device will then be removed without injection of ethacrynic acid
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 with ethacrynic acid injection
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). The next 15 patients will have the device placed on the eye with a subsequent injection of ethacrynic acid into the episcleral vein. The Retroject device will then be removed after 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.
Other: ethacrynic acid or balanced salt solution
randomization of ethacrynic acid or balanced salt solution

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02051946

Locations
United States, North Carolina
Duke University Eye Center Not yet recruiting
Durham, North Carolina, United States, 27710
Contact: Rand Allingham, MD    919-684-2975    rand.allingham@dm.duke.edu   
Contact: Molly Walsh, MD    919-681-8636    molly.walsh@dm.duke.edu   
Sub-Investigator: Molly Walsh, MD         
Sub-Investigator: Stuart McKinnon, MD         
Sponsors and Collaborators
Molly Walsh
Investigators
Principal Investigator: Rand Allingham, MD Duke University Eye Center
  More Information

No publications provided

Responsible Party: Molly Walsh, Assistant Professor, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT02051946     History of Changes
Other Study ID Numbers: Pro00039988
Study First Received: January 29, 2014
Last Updated: April 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Duke University:
novel drug delivery technique for glaucoma patients

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

ClinicalTrials.gov processed this record on July 31, 2014