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

This study is not yet open for participant recruitment.
Verified April 2012 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01295073
First received: February 10, 2011
Last updated: April 5, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Trientine Hydrochloride for the Prevention of Macular Edema After Cataract Surgery in Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • The primary analysis will compare retinal thickness measurements by Optical Coherence Tomography (OCT) between subjects undergoing surgery with and without Trientine use. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary analyses will involve evaluations of visual acuity and fundus photography. [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: June 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
see above

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01295073

Contacts
Contact: Cheyenne Johnson 604-875-4111 ext 62544 cjohnson@eyecarecentre.org

Locations
Canada, British Columbia
Univeristy of British Columbia/Vancouver Coastal Health Authority - Eye Care Center Not yet recruiting
Vancouver, British Columbia, Canada
Contact: Cheyenne Johnson     604-875-4111 ext 62544     cjohnson@eyecarecentre.org    
Principal Investigator: David Maberley, MD, FRCS (C), MSc (Epid)            
Sub-Investigator: Patrick Ma            
Sub-Investigator: David Rollins            
Sub-Investigator: Joanne Matsubara            
Sponsors and Collaborators
University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01295073     History of Changes
Other Study ID Numbers: H11-00165
Study First Received: February 10, 2011
Last Updated: April 5, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Trientine
Cataract surgery
Macular Edema

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Edema
Macular Edema
Cataract
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Signs and Symptoms
 Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Lens Diseases
Trientine
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013