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

Phase 2

Withdrawn

• Conditions: Macular Edema Following Cataract Surgery
• Interventions: Drug: Trientine Hydrochloride; Other: For Arm B there is no therapeutic intervention other than standard of care, which is cataract surgery.

• Registration Number: NCT01295073
• Lead Sponsor: University of British Columbia

Brief 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.

Detailed Description

Individuals with type II Diabetes Mellitus who present to the UBC/VGH Eye Care Centre for cataract surgery will be offered participation in this study. Cataract surgery will be performed according to the surgeons' normal protocols and the present standards of care; however, subjects will be randomized to either a 10-day course of oral Trientine at 1500mg/day administered for 7 days prior to and 3 days after the surgery, or to placebo. Urinary copper levels will be evaluated before and after Trientine administration to determine the efficacy of copper chelation at the time of surgery.

Baseline ocular exams, bloodwork and urine collection will be organized or performed at the two screening visits up to two months before the date of cataract surgery according to the research protocol (flowsheet included at the end). Subjects will also be evaluated at Day1 post-operative, Day 7 (Week #1) post operative, and Day 28-30 (Month 1)post operative with Ocular Coherence Tomography (retinal thickness measurements). Fundus photography and visual acuity testing will be done at Screening and month 1. A final phlebotomy to rule out copper deficiency anemia will be required at month 1 as well.

Study Timeline

• Study First Submitted: 2011-02-10
• Study First Submitted QC: 2011-02-10
• Study First Posted: 2011-02-14
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-03
• Last Update Posted: 2018-05-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Trientine Hydrochloride	Oral Trientine 1500mg x 1 week before cataract surgery and 3 days post surgery
B	For Arm B there is no therapeutic intervention other than standard of care, which is cataract surgery.	Oral Placebo x 1 week before cataract surgery and 3 days post surgery

Primary Outcome Measures

Name	Time	Method
Change in retinal thickness measurements by Optical Coherence Tomography (OCT) from screening to Day 28 between subjects undergoing surgery with and without Trientine use.	Screening, Day 28

Secondary Outcome Measures

Name	Time	Method
Secondary analyses will involve evaluations of the change in visual acuity and fundus photography results from screening to Day 28.	Screening, Day 28

Trial Locations

Locations (1)

Univeristy of British Columbia/Vancouver Coastal Health Authority - Eye Care Center; 🇨🇦 Vancouver, British Columbia, Canada