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

• Status: Terminated
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of British Columbia
• Treatments: Trientine

Criteria

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 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.