Novel Drug Delivery Technique Via Retroject Device

Glaucoma Clinical Trial

Official title:

Novel Drug Delivery Technique for Glaucoma Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02051946
• Other study ID #: Pro00039988
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 29, 2014
• Last updated: February 15, 2017
• Start date: May 2014
• Est. completion date: October 2015

Study information

• Verified date: February 2017
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Glaucoma

Intervention

Device:
• Retroject Device

Drug:
• ethacrynic acid injection

• balanced salt solution

Locations

Country	Name	City	State
United States	Duke University Eye Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Molly Walsh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Corneal endothelial cell counts	Pre and post injection (6 weeks) endothelial counts will be performed for each patient.	6 weeks after injection
Primary	Change in Intraocular pressures (IOP) lowering effect	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.	Days 1, 2, 3, and 7, and 6 weeks after injection