Trientine Hydrochloride for the Prevention of Macular Edema Associated With Pan-retinal Photocoagulation for Severe Non-proliferative and Proliferative Diabetic Retinopathy
NCT01213888 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3
Last updated 2013-05-03
Summary
To evaluate the effects of Trientine Hydrochloride in prevention of post-laser (pan-retinal photocoagulation) macular edema in the eyes for subjects with diabetic retinopathy. Trientine hydrochloride can limit secondary inflammatory damage to retinal vessels following the administration of pan-retinal photocoagulation therapy for severe non-proliferative diabetic retinopathy or retinal neovascularization due to diabetic retinopathy, resulting in less macular edema and improved visual outcomes.
Conditions
Interventions
- DRUG
-
Trientine Hydrochloride
All participating subjects will all receive PRP (pan-retinal photocoagulation) according to present standards of care; however, subjects randomized the intervention group (trientine hydrochloride) will be on a 10-day course of oral Trientine at 1500mg administered for 7-days prior to and 3 days after the PRP sessions.
- DRUG
-
Oral placebo capsules
All participating subjects will all receive PRP (pan-retinal photocoagulation) according to present standards of care; however, subjects randomized the placebo group will be on a 10-day course of oral placebo capsules at 1500mg administered for 7-days prior to and 3 days after the PRP sessions
Sponsors & Collaborators
-
University of British Columbia
lead OTHER
Principal Investigators
-
Patrick Ma · University of British Columbia
-
Andrew Merkus · University of British Columbia
-
David Albiani · University of British Columbia
-
David Maberly · University of British Columbia
Study Design
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2010-11-30
- Primary Completion
- 2013-04-30
- Completion
- 2013-04-30
Countries
- Canada
Study Locations
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