Diabetic RetinopathyNCT01213888
Trientine Hydrochloride for the Prevention of Macular Edema Associated With Pan-retinal Photocoagulation for Severe Non-proliferative and Proliferative Diabetic Retinopathy
A study testing Trientine Hydrochloride in people with Diabetic Retinopathy, run by University of British Columbia at 1 site in Canada.
Trial summary
To evaluate the effects of Trientine Hydrochloride in prevention of post-laser (pan-retinal photocoagulation) macular edema in the eyes for subjects with diabetic retinopathy. Trientine hydrochloride can limit secondary inflammatory damage to retinal vessels following the administration of pan-retinal photocoagulation… Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Retinopathy
- 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
- 3 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2010to Apr 2013
- Phase
- Interventional
- 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
- Severe non-proliferative diabetic retinopathy or retinal neovascularization secondary to diabetic retinopathy meeting DRS criteria for PRP laser
- ETDRS (Early treatment of Diabetic Retinopathy Study) eye score of at least 34-73 letters (at 2 meters) (20/20 to 20/320) for study eye and 20/800 in non-study eye
- Clinical evidence of macular microantiopathy in the study eye (lipid or retinal thickness is acceptable)
- No other ocular disease that could be responsible for decreased vision, macular edema or could limit macular imaging
Who cannot join
- Individuals with retinal neovascularization from causes other than diabetic retinopathy
- Any intraocular surgery within 2 months or Yag capsulotomy within 1 month in the study eye
- Prior retinal or vitreous surgery (including posterior segment vitrectomy or scleral buckling)
- Medical conditions requiring the use of mineral supplements (copper in particular)
- Individuals with anemia
- Individuals with mental or physical disabilities that prevent accurate vision testing
Show all 15Show fewer
- History of treatment of PDR by PRP
- Active hepatitis, clinically significant liver disease or any evidence of renal failure.
- Stroke or myocardial infarction within preceding 6 months or 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
- Women of childbearing potential not on 2 effective forms of birth control
- Women who are pregnant or plan to become pregnant
- Subjects with an allergy to fluorescein dye.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Eye Care Centre - Vancouver Coastal Health
Vancouver, British Columbia, V5Z 3N9
About this study
To evaluate the effects of Trientine Hydrochloride in prevention of post-laser (pan-retinal photocoagulation) macular edema in the eyes for subjects with diabetic retinopathy. Trientine hydrochloride can limit secondary inflammatory damage to retinal vessels following the administration of pan-retinal photocoagulation therapy for severe non-proliferative diabetic retinopathy or retinal neovascularization due to diabetic retinopathy, resulting in less macular edema and improved visual outcomes.
Read the detailed description
Individuals with new-onset severe non-proliferative diabetic retinopathy or retinal neovascularization who present to the retinal service of the UBC/VGH Eye Care Centre will be offered participation in this study. Subject inclusion criteria will parallel those of the DRS (Diabetic Retinopathy Study) and ETDRS (Early Treatment of Diabetic Retinopathy Study). One PRP session will consist of between 800 to 1000 laser burns. Subjects with discomfort during laser (a known side-effect) will be treated with local anesthetics.
As noted, participating subjects will all receive PRP according to present standards of care; however, subjects will be randomized to either a 10-day course of oral Trientine at 1500mg administered for 7-days prior to and 3 days after the PRP sessions, or a placebo. Serum copper levels and urinary copper levels will be evaluated before and after Trientine administration to determine the amount of free copper present systemically at the time of PRP treatment.
Ocular outcomes will include visual acuity testing (ETDRS), fluorescein angiography and ocular coherence tomography (OCT). These studies will be used to evaluate retinal morphology and photoreceptor function pre and post laser. All these evaluations are considered part of the routine evaluation of diabetic retinopathy in subjects being treated with PRP.
Outcome measures will be assessed at day 2-post laser, week 1, and Day 28-30. Further clinical PRP treatment will be administered if necessary after Day 28-30 at the discretion of the patients' ophthalmologist.
The primary analysis will involve comparing the retinal thickness measurements between subjects undergoing PRP with and without Trientine use. Secondary analyses will involve evaluations of visual acuity and fluorescein angiography. As well, changes in visual acuity, angiographic leakage, and retinal thickness will be regressed against serum copper levels. Sample size calculations suggest 15 subjects per arm should be adequate to demonstrate a 40% reduction in retinal thickness with a power of 80% comparing subjects receiving Trientine to controls.
Subjects who are randomized to Trientine will receive 1500 mg Trientine PO daily for 10 days. Subjects, study-coordinators, and investigators will be masked to treatment group. The primary analysis will be a comparison of OCT thickness measurements.
This is a single centre study involving 30 subjects (15 cases and 15 controls). A 1:1 randomization will be employed (Trientine 1500 mg: Placebo). No normal subjects will be enrolled.
- Conditions
- Diabetic Retinopathy
- Being tested
- Trientine Hydrochloride, Oral placebo capsules
- Keywords
- Diabetic retinopathy, pan-retinal photocoagulation, macular edema
- Medical subject headings
- Diabetic Retinopathy, 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
All participating subjects will all receive PRP (pan-retinal photocoagulation) 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 the PRP sessions.
Oral placebo capsulesDrug
All participating subjects will all receive PRP (pan-retinal photocoagulation) according to present standards of care; however, subjects randomized the placebo group will be on a 10-day course of oral placebo capsules at 1500mg administered for 7-days prior to and 3 days after the PRP sessions
| Study group | Role | What they receive |
|---|---|---|
| Arm II | Experimental | Not described Receives: Drug: Trientine Hydrochloride |
| Arm I. Placebo + Pan-Retinal Photocoagulation | Placebo comparator | All participating subjects will all receive PRP (pan-retinal photocoagulation) according to present standards of care; however, subjects randomized the placebo group will be on a 10-day course of oral placebo capsules at 1500mg administered for 7-days prior to and 3 days after the PRP sessions. Receives: Drug: Oral placebo capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of a copper chelator in suppressing post-PRP macular edema in eyes with retinal neovascularization.
The treatment effect will be measured by assessing changes in photoreceptor function (via visual acuity and contrast sensitivity) as well as retinal inflammation and thickening (via Fluorescein Angiography and Ocular Coherence Tomography).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2010 (estimated)
- Study startNov 2010
- Primary completionApr 2013
- Study completionApr 2013
Why it stopped: Low enrollment \& superior treatments available for diabetic macular edema including anti-VEFG therapies such as bevacizumab and ranibizumab.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies 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 N/A
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Ma, Study director, University of British ColumbiaAndrew Merkus, Study director, University of British ColumbiaDavid Albiani, Study director, University of British ColumbiaDavid Maberly, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01213888
- Sponsor's protocol ID
- H08-01900
- Status last verified
- May 2013
- First submitted
- 30 Sep 2010
- Last updated
- 3 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trientine Hydrochloride for the Prevention of Macular Edema Associated With Pan-retinal Photocoagulation for Severe Non-proliferative and Proliferative Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT01213888
- Acronym / sponsor ID
- H08-01900
- Conditions
- Diabetic Retinopathy
- Keywords
- Diabetic retinopathy, pan-retinal photocoagulation, macular edema
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment \& superior treatments available for diabetic macular edema including anti-VEFG therapies such as bevacizumab and ranibizumab.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 4 Oct 2010 (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.
To evaluate the effects of Trientine Hydrochloride in prevention of post-laser (pan-retinal photocoagulation) macular edema in the eyes for subjects with diabetic retinopathy. Trientine hydrochloride can limit secondary inflammatory damage to retinal vessels following the administration of pan-retinal photocoagulation therapy for severe non-proliferative diabetic retinopathy or retinal neovascularization due to diabetic retinopathy, resulting in less macular edema and improved visual outcomes.
Detailed description
Individuals with new-onset severe non-proliferative diabetic retinopathy or retinal neovascularization who present to the retinal service of the UBC/VGH Eye Care Centre will be offered participation in this study. Subject inclusion criteria will parallel those of the DRS (Diabetic Retinopathy Study) and ETDRS (Early Treatment of Diabetic Retinopathy Study). One PRP session will consist of between 800 to 1000 laser burns. Subjects with discomfort during laser (a known side-effect) will be treated with local anesthetics.
As noted, participating subjects will all receive PRP according to present standards of care; however, subjects will be randomized to either a 10-day course of oral Trientine at 1500mg administered for 7-days prior to and 3 days after the PRP sessions, or a placebo. Serum copper levels and urinary copper levels will be evaluated before and after Trientine administration to determine the amount of free copper present systemically at the time of PRP treatment.
Ocular outcomes will include visual acuity testing (ETDRS), fluorescein angiography and ocular coherence tomography (OCT). These studies will be used to evaluate retinal morphology and photoreceptor function pre and post laser. All these evaluations are considered part of the routine evaluation of diabetic retinopathy in subjects being treated with PRP.
Outcome measures will be assessed at day 2-post laser, week 1, and Day 28-30. Further clinical PRP treatment will be administered if necessary after Day 28-30 at the discretion of the patients' ophthalmologist.
The primary analysis will involve comparing the retinal thickness measurements between subjects undergoing PRP with and without Trientine use. Secondary analyses will involve evaluations of visual acuity and fluorescein angiography. As well, changes in visual acuity, angiographic leakage, and retinal thickness will be regressed against serum copper levels. Sample size calculations suggest 15 subjects per arm should be adequate to demonstrate a 40% reduction in retinal thickness with a power of 80% comparing subjects receiving Trientine to controls.
Subjects who are randomized to Trientine will receive 1500 mg Trientine PO daily for 10 days. Subjects, study-coordinators, and investigators will be masked to treatment group. The primary analysis will be a comparison of OCT thickness measurements.
This is a single centre study involving 30 subjects (15 cases and 15 controls). A 1:1 randomization will be employed (Trientine 1500 mg: Placebo). No normal subjects will be enrolled.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm II | Experimental | Drug: Trientine Hydrochloride |
| Arm I. Placebo + Pan-Retinal Photocoagulation | Placebo comparator | Drug: Oral placebo capsulesAll participating subjects will all receive PRP (pan-retinal photocoagulation) according to present standards of care; however, subjects randomized the placebo group will be on a 10-day course of oral placebo capsules at 1500mg administered for 7-days prior to and 3 days after the PRP sessions. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Severe non-proliferative diabetic retinopathy or retinal neovascularization secondary to diabetic retinopathy meeting DRS criteria for PRP laser
- ETDRS (Early treatment of Diabetic Retinopathy Study) eye score of at least 34-73 letters (at 2 meters) (20/20 to 20/320) for study eye and 20/800 in non-study eye
- Clinical evidence of macular microantiopathy in the study eye (lipid or retinal thickness is acceptable)
- No other ocular disease that could be responsible for decreased vision, macular edema or could limit macular imaging
Key exclusion criteria (15 listed)
- Individuals with retinal neovascularization from causes other than diabetic retinopathy
- Any intraocular surgery within 2 months or Yag capsulotomy within 1 month in the study eye
- Prior retinal or vitreous surgery (including posterior segment vitrectomy or scleral buckling)
- Medical conditions requiring the use of mineral supplements (copper in particular)
- Individuals with anemia
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: SyprineAll participating subjects will all receive PRP (pan-retinal photocoagulation) 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 the PRP sessions. | Drug | Arm II |
| Oral placebo capsulesAll participating subjects will all receive PRP (pan-retinal photocoagulation) according to present standards of care; however, subjects randomized the placebo group will be on a 10-day course of oral placebo capsules at 1500mg administered for 7-days prior to and 3 days after the PRP sessions | Drug | Arm I. Placebo + Pan-Retinal Photocoagulation |
Primary outcome
To evaluate the effect of a copper chelator in suppressing post-PRP macular edema in eyes with retinal neovascularization.
The treatment effect will be measured by assessing changes in photoreceptor function (via visual acuity and contrast sensitivity) as well as retinal inflammation and thickening (via Fluorescein Angiography and Ocular Coherence Tomography).
Results and safety
The study was stopped early (reason given: Low enrollment \& superior treatments available for diabetic macular edema including anti-VEFG therapies such as bevacizumab and ranibizumab.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2013.
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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.
Patrick Ma study director
University of British Columbia
Andrew Merkus study director
University of British Columbia
David Albiani study director
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 study testing Trientine Hydrochloride in people with Diabetic Retinopathy, 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 4 inclusion and 15 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: stopped early, as of the sponsor's last update on 3 May 2013. 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.
Are results available for this study?
The study was stopped early (reason given: Low enrollment \& superior treatments available for diabetic macular edema including anti-VEFG therapies such as bevacizumab and ranibizumab.). Results are not available in the source record.
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?
To evaluate the effect of a copper chelator in suppressing post-PRP macular edema in eyes with retinal neovascularization.. 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 3 May 2013.