Trientine Hydrochloride for the Prevention of Macular Edema After Cataract Surgery in Patients With Type 2 Diabetes Mellitus

Conditions

• Macular Edema Following Cataract Surgery

Eligibility Criteria

Sex

ALL

Age

19 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Trientine Hydrochloride — DRUG
  Arm A's therapeutic intervention is the use of Trientine Hydrochloride for 10 days in the perioperative period. All participating subjects will all receive cataract surgery 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 surgery.
• For Arm B there is no therapeutic intervention other than standard of care, which is cataract surgery. — OTHER
  see above

Study Details

The primary purpose of the protocol is to evaluate whether Trientine Hydrochloride, a copper chelator which is an agent that binds with and removes copper, will be effective in minimizing macular edema after cataract surgery in individuals with type 2 diabetes. It is our hypothesis that there will be a reduction in copper-attributed inflammation after surgery resulting a decrease in edema.

Key Dates

First listed

Feb 14, 2011

Status verified

May 2018

Study Design

Enrollment

0 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Active Comparator: A
  Oral Trientine 1500mg x 1 week before cataract surgery and 3 days post surgery
• Placebo Comparator: B
  Oral Placebo x 1 week before cataract surgery and 3 days post surgery

Primary Outcome Measure

Change in retinal thickness measurements by Optical Coherence Tomography (OCT) from screening to Day 28 between subjects undergoing surgery with and without Trientine use. [ Time Frame: Screening, Day 28 ]