Treatment of Diabetic Macular Edema: Triamcinolone Injections Vs. Laser Photocoagulation

NCT00105404 | Completed Phase 3

• 2 other identifiers: 05010705-EI-0107
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare the side effects of two treatments for diabetic macular edema, in which blood vessels in the retina (tissue that lines the back of the eye) become leaky and the retina and macula (the center part of the retina that is responsible for fine vision) swell, causing vision loss. Patients 18 years of age and older with diabetes mellitus and macular edema in one or both eyes may be eligible for this study. Candidates are screened with the following tests and procedures:

• Blood pressure measurement.
• Blood tests to measure HbA1c, a measure of the patient's diabetes control.
• Eye examination to assess visual acuity and eye pressure, and to examine pupils, lens, retina and eye movements. The pupils are dilated with drops for this examination.
• Eye photography to help evaluate the status of the retina and changes that may occur in the future. Photographs of the inside of the eye are taken using a camera that flashes a bright light into the eye.
• Electroretinograms (ERG) to measure electrical responses generated in the retina. Wearing eye patches, the patient sits in a dark room for 30 minutes. Then, electrodes are taped to the forehead and an earlobe. The eye patches are removed, the surface of the eye is numbed with eye drops, and contact lenses are placed on the eyes. The patient looks inside a white globe that emits a series of light flashes for about 20 minutes. The contact lenses sense small electrical signals generated by the retina when the light flashes.
• Optical coherence tomography to measure retinal thickness. The eye is examined with a machine that produces cross-sectional pictures of the retina. These measurements are repeated during the study to determine whether retinal thickening is improving, worsening, or staying the same. Patients with macular edema in both eyes receive laser therapy in one eye and triamcinolone injections in the other. Patients with just one affected eye are randomly assigned to receive either laser or triamcinolone treatment. Those who receive only laser therapy may later receive triamcinolone injections in the second eye if it, too, develops macular edema. For the laser treatment, the eye surface is numbed with drops and a contact lens is placed on the eye during the laser beam application. Before the treatment, patients may have fluorescein angiography, in which pictures of the retina are taken using a yellow dye. The dye is injected into a vein and travels to the blood vessels in the eye. The camera flashes a blue light in the eye and takes pictures that show the amount of dye leakage into the retina. This helps guide the laser treatment. Patients return for follow-up visits every 4 months for 3 years. If the macular edema is gone, no additional treatment is given and patients are followed as often as every 2 months. If the edema does return, additional treatments may be done at subsequent visits. Patients whose vision worsens considerably at the end of 1 year may be treated with a steroid injection, unless the other eye has also been treated with triamcinolone. For the triamcinolone injections, numbing drops, antibiotic drops, and drops to dilate the pupil, and possibly and anesthetic injection, are put in the eye before the medicine is injected into the vitreous (jelly-like substance inside the eye). Then, the patient lies on his or her back for 30 minutes before being discharged home. Patients return for follow-up visits 4 days and 4 weeks after the injection, and then every 4 months for 3 years. Patients whose edema resolves are followed as often as every 2 months. Those whose edema returns have additional injections at the 4-month visits. Patients whose condition does not improve after 1 year or whose vision worsens may undergo laser treatment.

Conditions

Diabetic Retinopathy; Diabetic Macular Edema; DME

Keywords

Steroid; Diabetic Macular Edema; DME

Interventions

Triamcinolone Acetonide DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than or equal to 18 years.
• Diagnosis of diabetes mellitus (type 1 or type 2).
• Any one of the following will be considered to be sufficient evidence that diabetes is present:
• Current regular use of insulin for the treatment of diabetes
• Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes
• Documented diabetes by ADA and/or WHO criteria
• At least one eye meets the study eye criteria.
• If only one eye eligible, fellow eye meets criteria
• Able and willing to provide informed consent.
• Patient understands that (1) if both eyes are eligible at the time of randomization, one eye will receive intravitreal triamcinolone ancetonide and one eye will receive laser, and (2) if only one eye is eligible at the time of randomization and the fellow eye develops DME later, then the fellow eye will not receive intravitreal triamcinolone ancetonide if the study eye received intravitreal triamcinolone ancetonide (however, if the study eye was assigned to the laser group, then the fellow eye may be treated with the 4mg dose of the study intravitreal triamcinolone ancetonide formulation, provided the eye assigned to laser has not received an intravitreal injection; such an eye will not be a study eye but since it is receiving study drug, it will be followed for adverse effects).

You may not qualify if:

• History of chronic renal failure requiring dialysis or kidney transplant.
• A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure and glycemic control).
• \- Patients in poor gylcemic control who, within the last 4 months, initiated intensive insulin treatment (a pump or multiple daily injections) or plan to do so in the next 4 months should not be enrolled.
• Participation in an investigational trial within 30 days of study entry that involved treatment with any drug that has not received regulatory approval at the time of study entry.
• Known allergy to any corticosteroid or any component of the delivery vehicle.
• History of systemic (e.g., oral, IV, IM, epidural, bursal) corticosteroids within 4 months prior to randomization or topical, rectal,or inhaled corticosteroids in current use more than 2 times per week.
• Patient is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the 3 years of the study.
• Blood pressure greater than 180/110 (systolic above 180 or diastolic above 110).
• \- If blood pressure is brought below 180/110 by anti-hypertensive treatment, patient can become eligible.
• A patient may have two study eyes only if both are eligible at the time of randomization.
• The eligibility criteria for a study eye are as follows:
• Best corrected E-ETDRS visual acuity score of greater than or equal to 24 letters (i.e., 20/320 or better) and less than or equal to 68 letters (i.e., worse than 20/40).
• \- There will be an enrollment limit of approximately 10% of eyes with visual acuity of 64 to 68 letters.
• Definite retinal thickening due to diabetic macular edema based on clinical exam involving the center of the macula.
• Mean retinal thickness on two OCT measurements greater than or equal to 250 microns in the central subfield.

Sponsors & Collaborators

• National Eye Institute (NEI): lead

Study Sites (1)

National Eye Institute (NEI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• Moss SE, Klein R, Klein BE. The 14-year incidence of visual loss in a diabetic population. Ophthalmology. 1998 Jun;105(6):998-1003. doi: 10.1016/S0161-6420(98)96025-0.

  PMID: 9627648 BACKGROUND

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: March 11, 2005
• First Posted: March 14, 2005
• Study Start: March 9, 2005
• Study Completion: October 30, 2006
• Last Updated: July 2, 2017

Record last verified: 2006-10-30

Locations

US (1)