- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01295073
Trientine Hydrochloride for the Prevention of Macular Edema After Cataract Surgery in Patients With Type 2 Diabetes Mellitus
Study Overview
Status
Conditions
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 Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada
- Univeristy of British Columbia/Vancouver Coastal Health Authority - Eye Care Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: A
Oral Trientine 1500mg x 1 week before cataract surgery and 3 days post surgery
|
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 Names:
|
Placebo Comparator: B
Oral Placebo x 1 week before cataract surgery and 3 days post surgery
|
see above
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Screening, Day 28
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Screening, Day 28
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David Maberley, MD,FRCSC,MSc(Epid), University of British Columbia
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Eye Diseases
- Endocrine System Diseases
- Retinal Degeneration
- Retinal Diseases
- Macular Degeneration
- Lens Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Macular Edema
- Cataract
- Edema
- Capsule Opacification
- Molecular Mechanisms of Pharmacological Action
- Chelating Agents
- Sequestering Agents
- Trientine
Other Study ID Numbers
- H11-00165
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Macular Edema Following Cataract Surgery
-
Klinički Bolnički Centar ZagrebUniversity of ZagrebCompleted
-
Iladevi Cataract and IOL Research CenterCompleted
-
Medical University of GrazCompletedCystoid Macular Edema Following Cataract Surgery | Vitreous Hyperreflective DotsAustria
-
University of Campinas, BrazilCompletedCystoid Macular Edema Following Cataract Surgery, BilateralBrazil
-
Postgraduate Institute of Medical Education and...CompletedDiabetic Macular Edema | Cataract | Vision Disorders | Macular Edema, Cystoid | Cystoid Macular Edema Following Cataract SurgeryIndia
-
European School of Advanced Studies in OphthalmologyCompletedDiabetic Macular Edema | Cataract Senile | Surgery--ComplicationsSwitzerland
-
Showa UniversityCompletedto Compare the Effect of Two Types of IOLs | on the Incidence of Cystoid Macular Edema | After Cataract SurgeryJapan
-
Northern California Retina Vitreous AssociatesAllerganCompletedDiabetic Macular Edema | Pseudophakic Cystoid Macular Edema,United States
-
TRB ChemedicaCompleted
-
Queen's UniversityCompleted
Clinical Trials on Trientine Hydrochloride
-
University of British ColumbiaTerminated
-
Univar BVAptiv SolutionsCompleted
-
Univar BVUnknownWilson DiseaseUnited Kingdom, Germany, Greece, Italy
-
Yale UniversityBausch Health Americas, Inc.CompletedWilson DiseaseUnited States
-
Duke UniversityWithdrawn
-
M.D. Anderson Cancer CenterCompleted
-
National Center for Research Resources (NCRR)University of MichiganCompleted
-
Manchester University NHS Foundation TrustUniversity of Oxford; University of Liverpool; University of Manchester; National... and other collaboratorsActive, not recruitingHypertrophic CardiomyopathyUnited Kingdom
-
OrphalanCompletedWilson DiseaseUnited States, United Kingdom, Belgium, Brazil, Denmark, France, Germany, Italy, Poland
-
ExcelsiorCompletedTrientine Treatment for Wilson's DiseaseTaiwan