Status:
TERMINATED
Trientine Hydrochloride for the Prevention of Macular Edema Associated With Pan-retinal Photocoagulation for Severe Non-proliferative and Proliferative Diabetic Retinopathy
Lead Sponsor:
University of British Columbia
Conditions:
Diabetic Retinopathy
Eligibility:
All Genders
19+ years
Phase:
NA
Brief 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 ...
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 i...
Eligibility Criteria
Inclusion
- 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
- 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 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.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01213888
Start Date
November 1 2010
End Date
April 1 2013
Last Update
May 3 2013
Active Locations (1)
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1
Eye Care Centre - Vancouver Coastal Health
Vancouver, British Columbia, Canada, V5Z 3N9