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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
DIABETIC MACULAR EDEMA	Drug: Triamcinolone acetonide; Procedure: laser	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 11 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Role of Triamcinolone Injection During Cataract Extraction for Diabetic Patients With Pre-Operative Macular Edema
• Study Start Date: November 2005
• Actual Primary Completion Date: May 2013
• Actual Study Completion Date: May 2013

Arms and Interventions

Arm	Intervention/treatment
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.	Procedure: laser; Laser treatment 1 month after cataract surgery with option to repeat once if no improvement.; Other Name: focal laser photocoagulation
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.	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

Outcome Measures

Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. Rate of Elevated Intraocular Pressures, Retinal Detachment, Infection, and Vitreous Hemorrhage. [ Time Frame: 3 years ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Oklahoma

Dean A. McGee Eye Institute

Oklahoma City, Oklahoma, United States, 73104

Sponsors and Collaborators

University of Oklahoma

Investigators

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

More Information

Additional Information:

Dean McGee Eye Institute 

• Responsible Party: University of Oklahoma
• ClinicalTrials.gov Identifier: NCT00229931
• Other Study ID Numbers: 2746
• First Posted: September 30, 2005
• Results First Posted: July 28, 2017
• Last Update Posted: July 28, 2017
• Last Verified: June 2017

Keywords provided by University of Oklahoma:

CATARACT EXTRACTION; MACULAR EDEMA; DIABETES; FOCAL LASER; TRIAMCINOLONE

Additional relevant MeSH terms:

Macular Edema; Edema; Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Immunosuppressive Agents; Immunologic Factors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action