Trientine Hydrochloride for the Prevention of Macular Edema Associated With Pan-retinal Photocoagulation for Severe Non-proliferative and Proliferative Diabetic Retinopathy

Sponsor
University of British Columbia
Study ID
NCT01213888
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Trientine Hydrochloride — DRUG
    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.
  • Oral placebo capsules — DRUG
    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

Study Details

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.

Key Dates

First listed
Oct 4, 2010
Start date
Nov 30, 2010
Status verified
May 2013
Primary completion
Apr 30, 2013
Completion
Apr 30, 2013

Study Design

Enrollment
3 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP

Arms

  • Experimental: Arm II
  • Placebo Comparator: Arm I. Placebo + Pan-Retinal Photocoagulation
    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.

Primary Outcome Measure

To evaluate the effect of a copper chelator in suppressing post-PRP macular edema in eyes with retinal neovascularization.

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