Triamcinolone vs. Laser for Diabetic Macular Edema (IVTA)

• ClinicalTrials.gov Identifier: NCT00229931
• Recruitment Status: Completed
• First Posted: September 30, 2005
• Results First Posted: July 28, 2017
• Last Update Posted: July 28, 2017
• Sponsor: University of Oklahoma
• Information provided by (Responsible Party): University of Oklahoma

Tracking Information

• First Submitted Date: September 28, 2005
• First Posted Date: September 30, 2005
• Results First Submitted Date: April 10, 2017
• Results First Posted Date: July 28, 2017
• Last Update Posted Date: July 28, 2017
• Study Start Date: November 2005
• Actual Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 29, 2017): Main Outcome Measures Will be Quantitative Changes in OCT Central Thickness, Visual Acuity, and Number of Snellen Acuity Lines Gained/Lost. [ Time Frame: 3 years ]
• Original Primary Outcome Measures (submitted: September 28, 2005): Main outcome measures will be quantitative changes in OCT central thickness, visual acuity, and number of Snellen acuity lines gained/lost.
• Current Secondary Outcome Measures (submitted: June 29, 2017): Rate of Elevated Intraocular Pressures, Retinal Detachment, Infection, and Vitreous Hemorrhage. [ Time Frame: 3 years ]
• Original Secondary Outcome Measures (submitted: September 28, 2005): Rate of elevated intraocular pressures, retinal detachment, infection, and vitreous hemorrhage.
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Triamcinolone vs. Laser for Diabetic Macular Edema
• Official Title: The Role of Triamcinolone Injection During Cataract Extraction for Diabetic Patients With Pre-Operative Macular Edema

Brief Summary

The purpose of this study is to determine if intravitreal triamcinolone acetonide (IVTA) injection at the time of cataract surgery will improve visual acuity and decrease post-operative swelling in diabetic patients requiring cataract extraction as compared to the conventional treatment of laser following cataract surgery.

The subjects will be followed for 11 visits over 3 year. Visits will occur at screening,1, 3,6,9,12,18,24,30 and 36 months post surgery.

Detailed Description

Protocol Summary:

This is a randomized, prospective study comparing diabetic patients with pre-operative macular edema undergoing cataract surgery treated with either 4 mg of intravitreal triamcinolone at the time of cataract surgery or focal laser treatment 1 month following cataract surgery.

Disease State:

The conventional treatment for clinically significant macular edema is focal laser photocoagulation. In some diabetic patients however, the cataract often impedes fundus visualization for optimal laser treatment. In these patients focal laser treatment is deferred until after cataract surgery.

Study aim:

The purpose of this study is to determine if intravitreal triamcinolone acetonide (IVTA) injection at the time of cataract surgery will improve visual acuity and decrease post-operative macular edema in diabetic patients with pre-operative macular edema requiring cataract extraction as compared to the conventional treatment of focal laser photocoagulation following cataract surgery.

Hypothesis:

We propose that by injecting triamcinolone intravitreally at the time of cataract surgery in patients who have pre-operative macular edema, we will not only reduce the risk of exacerbating macular edema but also possibly improve the final visual outcome.

Study Procedures:

After informed consent is obtained each patient will be placed, based on a randomization scheme, into either the control group receiving the conventional focal laser treatment one month following cataract extraction or into the study group receiving the IVTA injection at the time of surgery.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: DIABETIC MACULAR EDEMA

Intervention

• Drug: Triamcinolone acetonide
  4mg of intravitreal triamcinolone at time of cataract surgery with option to repeat at one month if no response
  Other Name: Kenalog
• Procedure: laser
  Laser treatment 1 month after cataract surgery with option to repeat once if no improvement.
  Other Name: focal laser photocoagulation

Study Arms

• Active Comparator: Laser therapy
  If randomized to laser therapy at time of cataract surgery, laser therapy will be performed one month after cataract surgery. If macular edema does not respond an additional laser therapy will be performed. If macular edema persists after 2 lasers, then IVTA will be administered as per standard of care.
  Intervention: Procedure: laser
• Active Comparator: Triamcinolone therapy
  At time of cataract surgery, will have IVTA injection. If macular edema does not show improvement at 1 month, then can have repeat IVTA injection. If the macular edema is stil not improved after 2nd injection, participant will be considered "treatment failure" and will be given the option to have laser therapy.
  Intervention: Drug: Triamcinolone acetonide

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 2, 2014): 11
• Original Enrollment (submitted: September 28, 2005): 40
• Actual Study Completion Date: May 2013
• Actual Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• visually significant cataracts
• pre-operative visual acuity 20/50 or worse
• pre-operative optical coherence tomography (OCT) showing at least 250 microns central foveal thickness.

Exclusion Criteria:

• macular ischemia
• vitreomacular traction
• macular hole

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00229931
• Other Study ID Numbers: 2746
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: University of Oklahoma
• Original Responsible Party: Not Provided
• Current Study Sponsor: University of Oklahoma
• Original Study Sponsor: Dean A. McGee Eye Institute
• Collaborators: Not Provided

Investigators

• Principal Investigator: Robert E Leonard, MD; Dean A. McGee Eye Institute

• PRS Account: University of Oklahoma
• Verification Date: June 2017