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Sponsored by: |
National Eye Institute (NEI) |
Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00105404 |
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:
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.
Condition | Intervention | Phase |
Diabetic Retinopathy Diabetic Macular Edema DME |
Drug: Triamcinolone Acetonide |
Phase III |
Genetics Home Reference related topics: | X-linked juvenile retinoschisis |
MedlinePlus related topics: | Diabetic Eye Problems Edema Retinal Disorders |
ChemIDplus related topics: | Triamcinolone acetonide Triamcinolone Triamcinolone diacetate Triamcinolone hexacetonide |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Randomized Trial Comparing Intravitreal Triamcinolone Acetonide and Laser Photocoagulation for Diabetic Macular Edema |
Estimated Enrollment: | 5 |
Study Start Date: | March 2005 |
Estimated Study Completion Date: | October 2006 |
Diabetic retinopathy is a major cause of visual impairment in the United States. Diabetic Macular edema (DME) is a manifestation of diabetic retinopathy that produces loss of central vision. Data from the Wisconsin Epidemiologic Study of Diabetic Retinopathy (WESDR) estimate that after 15 years of known diabetes, the prevalence of diabetic macular edema is approximately 20% in patients with type 1 diabetes mellitus (DM), 25% in patients with type 2 DM who are taking insulin, and 14% in patients with type 2 DM who do not take insulin.
In a review of three early studies concerning the natural history of diabetic macular edema, Ferris and Patz found that 53% of 135 eyes with diabetic macular edema, presumably all involving the center of the macula, lost two or more lines of visual acuity over a two year period. In the Early Treatment Diabetic Retinopathy Study (ETDRS), 33% of 221 untreated eyes available for follow-up at the 3-year visit, all with edema involving the center of the macula at baseline, had experienced a 15 or more letter decrease in visual acuity score (equivalent to a doubling of the visual angle, e.g., 20/25 to 20/50, and termed moderate visual loss).
The frequency of an unsatisfactory outcome following laser photocoagulation in some eyes with diabetic macular edema has prompted interest in other treatment modalities. One such treatment is pars plana vitrectomy. These studies suggest that vitreomacular traction, or the vitreous itself, may play a role in increased retinal vascular permeability. Removal of the vitreous or relief of mechanical traction with vitrectomy and membrane stripping may be followed by substantial resolution of macular edema and corresponding improvement in visual acuity. However, this treatment may be applicable only to a specific subset of eyes with diabetic macular edema. It also requires a complex surgical intervention with its inherent risks, recovery time, and expense. Other treatment modalities such as pharmacologic therapy with oral protein kinase C inhibitors and antibodies targeted at vascular endothelial growth factor (VEGF) are under investigation. The use of intravitreal corticosteroids is another treatment modality that has generated recent interest.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
(Subject-Level Inclusion Criteria:)
To be eligible, the following inclusion criteria (1-6) must be met:
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:
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).
(Subject-Level Exclusion Criteria:)
A patient is not eligible if any of the following exclusion criteria (7-13) are present:
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.
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.
(Study Eye Inclusion Criteria:)
The patient must have at least one eye meeting all of the inclusion criteria (a-d) and none of the exclusion criteria (e-x) listed.
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.
Media clarity, pupillary dilation, and patient cooperation sufficient for adequate fundus photographs.
(Study Eye Exclusion Criteria:)
Macular edema is considered to be due to a cause other than diabetic macular edema.
- An eye should not be considered eligible: (1) if the macular edema is considered to be related to cataract extraction or (2) clinical exam and/or OCT suggests that vitreoretinal interface disease (e.g., a taut posterior hyaloid or epiretinal membrane) is the primary cause of the macular edema.
History of focal/grid macular photocoagulation within 15 weeks (3.5 months) prior to randomization.
History of open-angle glaucoma (either primary open-angle glaucoma or other cause of open-angle glaucoma; note: angle-closure glaucoma is not an exclusion).
(Fellow Eye Inclusion Criteria:)
In patients with only one eye meeting criteria to be a study eye at the time of randomization, the fellow eye must meet the following criteria:
No history of open-angle glaucoma (either primary open -angle glaucoma or other cause of open-angle glaucoma; note: angle-closure glaucoma is not an exclusion).
Study ID Numbers: | 050107, 05-EI-0107 |
First Received: | March 11, 2005 |
Last Updated: | February 24, 2007 |
ClinicalTrials.gov Identifier: | NCT00105404 |
Health Authority: | United States: Federal Government |
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