Macular Edema Following Cataract SurgeryPhase 2NCT01295073
Trientine Hydrochloride for the Prevention of Macular Edema After Cataract Surgery in Patients With Type 2 Diabetes Mellitus
A Phase 2 study testing Trientine Hydrochloride in people with Macular Edema Following Cataract Surgery, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Macular Edema Following Cataract Surgery
- What is being tested?
- Trientine Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Start not givento not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Univeristy of British Columbia/Vancouver Coastal Health Authority - Eye Care Center
Vancouver, British Columbia
About this study
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.
Read the 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.
- Conditions
- Macular Edema Following Cataract Surgery
- Being tested
- Trientine Hydrochloride, For Arm B there is no therapeutic intervention other than standard of care, which is cataract surgery.
- Keywords
- Trientine, Cataract surgery, Macular Edema
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trientine HydrochlorideDrug
Also called Syprine
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.
For Arm B there is no therapeutic intervention other than standard of care, which is cataract surgery.Other
see above
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Oral Trientine 1500mg x 1 week before cataract surgery and 3 days post surgery Receives: Drug: Trientine Hydrochloride |
| B | Placebo comparator | Oral Placebo x 1 week before cataract surgery and 3 days post surgery Receives: Other: For Arm B there is no therapeutic intervention other than standard of care, which is cataract surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in retinal thickness measurements by Optical Coherence Tomography (OCT) from screening to Day 28 between subjects undergoing surgery with and without Trientine use.
Measured: 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.
Measured: Screening, Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2011 (estimated)
Why it stopped: appropriate study medication supply could not be identified
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular Edema Following Cataract SurgeryStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Maberley, University of British Columbia
- Investigators
- David Maberley, MD,FRCSC,MSc(Epid), Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01295073
- Sponsor's protocol ID
- H11-00165
- Status last verified
- May 2018
- First submitted
- 10 Feb 2011
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trientine Hydrochloride for the Prevention of Macular Edema After Cataract Surgery in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01295073
- Acronym / sponsor ID
- H11-00165
- Conditions
- Macular Edema Following Cataract Surgery
- Keywords
- Trientine, Cataract surgery, Macular Edema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: appropriate study medication supply could not be identified
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- First posted
- 14 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Trientine HydrochlorideOral Trientine 1500mg x 1 week before cataract surgery and 3 days post surgery |
| B | Placebo comparator | Other: For Arm B there is no therapeutic intervention other than standard of care, which is cataract surgery.Oral Placebo x 1 week before cataract surgery and 3 days post surgery |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trientine HydrochlorideAlso: SyprineArm 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. | Drug | A |
| For Arm B there is no therapeutic intervention other than standard of care, which is cataract surgery.see above | Other | B |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Maberley, MD,FRCSC,MSc(Epid) principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trientine Hydrochloride in people with Macular Edema Following Cataract Surgery, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2018.