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

NCT01213888 | Terminated

• 1 other identifier: H08-01900
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Diabetic Retinopathy

Keywords

Diabetic retinopathy; pan-retinal photocoagulation; macular edema

Outcome Measures

Primary Outcomes (1)

• 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).

Study Arms (2)

Arm II

EXPERIMENTAL

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.

Drug: Oral placebo capsules

Interventions

Trientine Hydrochloride DRUG

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.

Also known as: Syprine

Arm II

Oral placebo capsules DRUG

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

Arm I. Placebo + Pan-Retinal Photocoagulation

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Eye Care Centre - Vancouver Coastal Health

Vancouver, British Columbia, V5Z 3N9, Canada

Location

MeSH Terms

Conditions

Diabetic Retinopathy; Macular Edema

Interventions

Trientine

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Macular Degeneration; Retinal Degeneration

Intervention Hierarchy (Ancestors)

Ethylenediamines; Diamines; Polyamines; Amines; Organic Chemicals

Study Officials

• Patrick Ma

  University of British Columbia

  STUDY DIRECTOR

• Andrew Merkus

  University of British Columbia

  STUDY DIRECTOR

• David Albiani

  University of British Columbia

  STUDY DIRECTOR

• David Maberly

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2010
• First Posted: October 4, 2010
• Study Start: November 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: May 3, 2013

Record last verified: 2013-05

Locations

CA (1)