Trientine Hydrochloride for the Prevention of Macular Edema After Cataract Surgery in Patients With Type 2 Diabetes Mellitus
|Macular Edema Following Cataract Surgery||Drug: Trientine Hydrochloride Other: For Arm B there is no therapeutic intervention other than standard of care, which is cataract surgery.||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
|Official Title:||Trientine Hydrochloride for the Prevention of Macular Edema After Cataract Surgery in Patients With Type 2 Diabetes Mellitus|
- Change in retinal thickness measurements by Optical Coherence Tomography (OCT) from screening to Day 28 between subjects undergoing surgery with and without Trientine use. [ Time Frame: Screening, Day 28 ]
- Secondary analyses will involve evaluations of the change in visual acuity and fundus photography results from screening to Day 28. [ Time Frame: Screening, Day 28 ]
|Study Start Date:||March 2017|
|Estimated Study Completion Date:||September 2018|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Active Comparator: A
Oral Trientine 1500mg x 1 week before cataract surgery and 3 days post surgery
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 Name: Syprine
Placebo Comparator: B
Oral Placebo x 1 week before cataract surgery and 3 days post surgery
Other: For Arm B there is no therapeutic intervention other than standard of care, which is cataract surgery.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01295073
|Contact: Theresa Wiens||604-875-4111 ext email@example.com|
|Canada, British Columbia|
|Univeristy of British Columbia/Vancouver Coastal Health Authority - Eye Care Center||Not yet recruiting|
|Vancouver, British Columbia, Canada|
|Contact: Theresa Wiens 604-875-4111 ext 62544 firstname.lastname@example.org|
|Principal Investigator: David Maberley, MD, FRCS (C), MSc (Epid)|
|Sub-Investigator: Patrick Ma|
|Sub-Investigator: David Rollins|
|Sub-Investigator: Joanne Matsubara|
|Principal Investigator:||David Maberley, MD,FRCSC,MSc(Epid)||University of British Columbia|