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Trientine Hydrochloride for the Prevention of Macular Edema After Cataract Surgery in Patients With Type 2 Diabetes Mellitus

NCT01295073 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2018-05-09

No results posted yet for this study

Summary

The primary purpose of the protocol is to evaluate whether Trientine Hydrochloride, a copper chelator which is an agent that binds with and removes copper, will be effective in minimizing macular edema after cataract surgery in individuals with type 2 diabetes. It is our hypothesis that there will be a reduction in copper-attributed inflammation after surgery resulting a decrease in edema.

Conditions

  • Macular Edema Following Cataract Surgery

Interventions

DRUG

Trientine Hydrochloride

Arm A's therapeutic intervention is the use of Trientine Hydrochloride for 10 days in the perioperative period. All participating subjects will all receive cataract surgery 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 surgery.

OTHER

For Arm B there is no therapeutic intervention other than standard of care, which is cataract surgery.

see above

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Principal Investigators

  • David Maberley, MD,FRCSC,MSc(Epid) · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01295073 on ClinicalTrials.gov