TerminatedNot Applicable

Trientine Hydrochloride for the Prevention of Macular Edema Associated With Pan-retinal Photocoagulation for Severe Non-proliferative and Proliferative Diabetic Retinopathy

Stopped: Low enrollment \& superior treatments available for diabetic macular edema including anti-VEFG therapies such as bevacizumab and ranibizumab.

Canada3 participantsStarted 2010-11

Plain-language 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 therapy for severe non-proliferative diabetic retinopathy or retinal neovascularization due to diabetic retinopathy, resulting in less macular edema and improved visual outcomes.

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To evaluate the effect of a copper chelator in suppressing post-PRP macular edema in eyes with retinal neovascularization.

Trial details

NCT IDNCT01213888

SponsorUniversity of British Columbia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-04

View on ClinicalTrials.gov More Diabetic Retinopathy trials