search
Back to results

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

Primary Purpose

Macular Edema Following Cataract Surgery

Status
Withdrawn
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Trientine Hydrochloride
For Arm B there is no therapeutic intervention other than standard of care, which is cataract surgery.
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Macular Edema Following Cataract Surgery focused on measuring Trientine, Cataract surgery, Macular Edema

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

INCLUSION CRITERIA:

  1. A diagnosis of type 2 Diabetes Mellitus.
  2. Early Treatment of Diabetic Retinopathy Study (ETDRS) eye chart score of 34 to 73 letters at 2 meters following auto-refraction. (20/20 to 20/320 [logMAR 0 to 1.2] for study eye.
  3. Willing and able to participate and provide written informed consent.
  4. Must be 19 years of age or older
  5. Patients must require cataract surgery as determined by an ophthalmologist.
  6. Patients must have standard, uncomplicated cataract surgery with a foldable lens planned.

EXCLUSION CRITERIA:

  1. Individuals with active retinal neovascularization.
  2. Any intraocular surgery within 2 months or laser surgery within 1 month in the study eye.
  3. Prior retinal or vitreous surgery including posterior segment vitrectomy or scleral buckling.
  4. Inadequate initial OCT scan for reliable baseline measurement of retinal thickness.
  5. Current macular edema not related to diabetes.
  6. Patients who have received treatment with Avastin or Lucentis or laser in either eye in the last 3 months.
  7. Other ocular disease unrelated to diabetes or cataract that the investigator believes could be affect macular imaging or visual outcome.
  8. Medical conditions requiring constant use of mineral supplements (copper, iron or zinc in particular). This does not include those with Age-related Macular Degeneration (AMD) who may safely stop vitamins and minerals for the 10 day course of the treatment.
  9. Patients with anemia.
  10. Patients with physical or mental disabilities that prevent accurate testing.
  11. Active hepatitis, clinically significant liver disease, or a recent history of alcohol abuse.
  12. Any evidence of renal failure or an eGFR of less than 80% of age-adjusted normals.
  13. Patients who had a stroke or myocardial infarction within the preceding 6 months or who have ventricular tachycardia under treatment.
  14. History of severe cardiac disease or unstable angina.
  15. Subjects who are in an experimental therapy study or who have received experimental therapy within the last 12 weeks.
  16. Subjects who are a poor medical risk because of other systemic diseases or active uncontrolled infections.
  17. Subjects with inflammatory systemic diseases, such as systemic lupus erythematous.
  18. Women of childbearing potential not on 2 effective forms of birth control.
  19. Women who are pregnant or plan to become pregnant.

Sites / Locations

  • Univeristy of British Columbia/Vancouver Coastal Health Authority - Eye Care Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

A

B

Arm Description

Oral Trientine 1500mg x 1 week before cataract surgery and 3 days post surgery

Oral Placebo x 1 week before cataract surgery and 3 days post surgery

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 10, 2011
Last Updated
May 3, 2018
Sponsor
University of British Columbia
search

1. Study Identification

Unique Protocol Identification Number
NCT01295073
Brief Title
Trientine Hydrochloride for the Prevention of Macular Edema After Cataract Surgery in Patients With Type 2 Diabetes Mellitus
Official Title
Trientine Hydrochloride for the Prevention of Macular Edema After Cataract Surgery in Patients With Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Withdrawn
Why Stopped
appropriate study medication supply could not be identified
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema Following Cataract Surgery
Keywords
Trientine, Cataract surgery, Macular Edema

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Oral Trientine 1500mg x 1 week before cataract surgery and 3 days post surgery
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Oral Placebo x 1 week before cataract surgery and 3 days post surgery
Intervention Type
Drug
Intervention Name(s)
Trientine Hydrochloride
Other Intervention Name(s)
Syprine
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
For Arm B there is no therapeutic intervention other than standard of care, which is cataract surgery.
Intervention Description
see above
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
INCLUSION CRITERIA: A diagnosis of type 2 Diabetes Mellitus. Early Treatment of Diabetic Retinopathy Study (ETDRS) eye chart score of 34 to 73 letters at 2 meters following auto-refraction. (20/20 to 20/320 [logMAR 0 to 1.2] for study eye. Willing and able to participate and provide written informed consent. Must be 19 years of age or older Patients must require cataract surgery as determined by an ophthalmologist. Patients must have standard, uncomplicated cataract surgery with a foldable lens planned. EXCLUSION CRITERIA: Individuals with active retinal neovascularization. Any intraocular surgery within 2 months or laser surgery within 1 month in the study eye. Prior retinal or vitreous surgery including posterior segment vitrectomy or scleral buckling. Inadequate initial OCT scan for reliable baseline measurement of retinal thickness. Current macular edema not related to diabetes. Patients who have received treatment with Avastin or Lucentis or laser in either eye in the last 3 months. Other ocular disease unrelated to diabetes or cataract that the investigator believes could be affect macular imaging or visual outcome. Medical conditions requiring constant use of mineral supplements (copper, iron or zinc in particular). This does not include those with Age-related Macular Degeneration (AMD) who may safely stop vitamins and minerals for the 10 day course of the treatment. Patients with anemia. Patients with physical or mental disabilities that prevent accurate testing. Active hepatitis, clinically significant liver disease, or a recent history of alcohol abuse. Any evidence of renal failure or an eGFR of less than 80% of age-adjusted normals. Patients who had a stroke or myocardial infarction within the preceding 6 months or who have ventricular tachycardia under treatment. History of severe cardiac disease or unstable angina. Subjects who are in an experimental therapy study or who have received experimental therapy within the last 12 weeks. Subjects who are a poor medical risk because of other systemic diseases or active uncontrolled infections. Subjects with inflammatory systemic diseases, such as systemic lupus erythematous. Women of childbearing potential not on 2 effective forms of birth control. Women who are pregnant or plan to become pregnant.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Maberley, MD,FRCSC,MSc(Epid)
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univeristy of British Columbia/Vancouver Coastal Health Authority - Eye Care Center
City
Vancouver
State/Province
British Columbia
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs