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OpenTrials
Completed

NCT Number: NCT02051946

Novel Drug Delivery Technique Via Retroject Device

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.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Duke University Eye Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Retroject Device

Device

ethacrynic acid injection

Drug

balanced salt solution

Drug

Primary outcomes

  1. 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 outcomes

  1. Corneal endothelial cell counts

    Time frame: 6 weeks after injection

    Pre and post injection (6 weeks) endothelial counts will be performed for each patient.

Sponsors and collaborators

Lead sponsor

Molly Walsh

Other

Registry information

Official study title

Novel Drug Delivery Technique for Glaucoma Patients

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 31, 2014
Registry last updated
Feb 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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