Intravitreal Triamcinolone Acetonide Versus Laser for Diabetic Macular Edema

Completed · Phase 3

Conditions studied: Diabetic Macular Edema

In brief

The study involves the enrollment of patients over 18 years of age with diabetic macular edema(DME). Patients with one study eye will be randomly assigned (stratified by visual acuity and prior laser) with equal probability to one of the three treatment groups: 1. Laser photocoagulation 2. 1mg intravitreal triamcinolone acetonide injection 3. 4mg intravitreal triamcinolone acetonide injection For patients with two study eyes (both eyes eligible at the time of randomization), the right eye (stratified by visual acuity and prior laser) will be randomly assigned with equal probabilities to one of the three treatment groups listed above. The left eye will be assigned to the alternative treatment (laser or triamcinolone). If the left eye is assigned to triamcinolone, then the dose (1mg or 4 mg) will be randomly assigned to the left eye with equal probability (stratified by visual acuity and prior laser). The study drug, triamcinolone acetonide, has been manufactured as a sterile intravitreal injectable by Allergan. Study eyes assigned to an intravitreal triamcinolone injection will receive a dose of either 1mg or 4mg. There is no indication of which treatment regimen will be better. Patients enrolled into the study will be followed for three years and will have study visits every 4 months after receiving their assigned study treatment. In addition, standard of care post-treatment visits will be performed at 4 weeks after each intravitreal injection.

Key facts

Study ID

NCT00367133

Run by

Jaeb Center for Health Research

People needed

840

Starts

2004-07-01

Expected to finish

2008-10-01

Last updated by the study team

2016-08-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• A patient is not eligible if any of the following exclusion criteria are present:
• 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). Note: Patients in poor glycemic 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 > 180/110 (systolic above 180 OR diastolic above 110). Note: If blood pressure is brought below 180/110 by anti-hypertensive treatment, patient can become eligible.
• Study Eye Eligibility
• Inclusion
• Best corrected Electronic-Early Treatment Diabetic Retinopathy Study (e-ETDRS) visual acuity score of ≥ 24 letters (i.e., 20/320 or better) and ≤73 letters (i.e., 20/40 or worse).
• Definite retinal thickening due to diabetic macular edema based on clinical exam involving the center of the macula.
• Mean retinal thickness on two Optical Coherence Tomography (OCT) measurements ≥250 microns in the central subfield.
• Media clarity, pupillary dilation, and patient cooperation sufficient for adequate fundus photographs.
• Exclusion
• Macular edema is considered to be due to a cause other than diabetic macular edema.
• An ocular condition is present such that, in the opinion of the investigator, visual acuity would not improve from resolution of macular edema (e.g., foveal atrophy, pigmentary changes, dense subfoveal hard exudates, nonretinal condition).
• An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass Syndrome, etc.)
• Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (i.e., cataract would be reducing acuity to 20/40 or worse if eye was otherwise normal).
• History of prior treatment with intravitreal corticosteroids.
• History of peribulbar steroid injection within 6 months prior to randomization.
• History of focal/grid macular photocoagulation within 15 weeks (3.5 months) prior to randomization.Note: Patients are not required to have had prior macular photocoagulation to be enrolled. If prior macular photocoagulation has been performed, the investigator should believe that the patient may possibly benefit from additional photocoagulation.
• History of panretinal scatter photocoagulation (PRP) within 4 months prior to randomization.
• Anticipated need for PRP in the 4 months following randomization.
• History of prior pars plana vitrectomy.

Where it is running

• SCPMG Regional Offices - Kaiser Permanente — Baldwin Park, California, United States
• Retina-Vitreous Associates Medical Group — Beverly Hills, California, United States
• University of California, Irvine — Irvine, California, United States
• Loma Linda University Health Care, Dept. of Ophthalmology — Loma Linda, California, United States
• Doheny Eye Institute — Los Angeles, California, United States
• Jules Stein Eye Institute — Los Angeles, California, United States
• Southern California Desert Retina Consultants, MC — Palm Springs, California, United States
• West Coast Retina Medical Group, Inc. — San Francisco, California, United States
• Orange County Retina Medical Group — Santa Ana, California, United States
• California Retina Consultants — Santa Barbara, California, United States
• Bay Area Retina Associates — Walnut Creek, California, United States
• Denver Health Medical Center — Denver, Colorado, United States
• Eldorado Retina Associates, P.C. — Louisville, Colorado, United States
• Connecticut Retina Consultants — New Haven, Connecticut, United States
• Connecticut Retina Consultants — New Haven, Connecticut, United States
• Retina Group of Florida — Fort Lauderdale, Florida, United States
• National Ophthalmic Research Institute — Fort Myers, Florida, United States
• Central Florida Retina Institute — Lakeland, Florida, United States
• Florida Retina Consultants — Lakeland, Florida, United States
• Sarasota Retina Institute — Sarasota, Florida, United States
• International Eye Center — Tampa, Florida, United States
• Southeast Retina Center, P.C. — Augusta, Georgia, United States
• Retina Associates of Hawaii, Inc. — Honolulu, Hawaii, United States
• Retina Consultants of Hawaii, Inc. — ‘Aiea, Hawaii, United States
• Jones Eye Institute/University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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