NCT01295073

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 14, 2011

Completed
Last Updated

May 9, 2018

Status Verified

May 1, 2018

First QC Date

February 10, 2011

Last Update Submit

May 3, 2018

Conditions

Macular Edema Following Cataract Surgery

Keywords

TrientineCataract surgeryMacular Edema

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    Screening, Day 28

Study Arms (2)

A

ACTIVE COMPARATOR

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

Drug: Trientine Hydrochloride

B

PLACEBO COMPARATOR

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.

Interventions

Trientine HydrochlorideDRUG

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.

Also known as: Syprine
A
For Arm B there is no therapeutic intervention other than standard of care, which is cataract surgery.OTHER

see above

B

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Macular Edema

Interventions

Trientine

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

EthylenediaminesDiaminesPolyaminesAminesOrganic Chemicals

Study Officials

  • David Maberley, MD,FRCSC,MSc(Epid)

    University of British Columbia

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 10, 2011

First Posted

February 14, 2011

Last Updated

May 9, 2018

Record last verified: 2018-05

Locations

CA(1)