Laser and Medical Treatment of Diabetic Macular Edema
Maneno muhimu
Kikemikali
Maelezo
This randomized pilot study is an important first step in planning a large multi-center clinical trial to evaluate medical and laser approaches that could improve the visual outcome for patients with diabetic retinopathy. This study will provide preliminary safety data on these therapies as well as allow for assessment of the performance of ocular outcomes and study design for use in subsequent trials. If there are no safety concerns, the results of this pilot will be helpful in the design of a large multicenter clinical trial by providing data on estimates of expected treatment effects. A larger trial will proceed regardless of whether or not this study identifies statistically significant main effects.
Using a partial factorial design, this study will compare (1) diode (micropulse) laser photocoagulation to mild ETDRS style focal photocoagulation and, (2) treatment with Vitamin E, a COX-2 inhibitor (celecoxib), or placebo prior to and following laser photocoagulation. The primary safety outcome is a visual acuity drop of 15 letters or more from baseline one year following initial laser treatment. The primary efficacy outcome will be reduction of the retinal thickening defined as an improvement by at least two steps (on standard fundus photos) combined with a 50% reduction in the area of fluorescein leakage one year after the initial laser compared to baseline. A secondary outcome will be the change in macular height as measured (OCT). These outcomes will be assessed for potential use in future trials. Concerns regarding safety and efficacy follow:
Safety
Is the risk of visual loss in patients with clinically significant diabetic macular edema potentially different across treatment groups?
Preliminary Assessment of Potential Outcomes
Is there evidence that any treatment combinations could be effective in reducing retinal thickening?
Is there evidence that Vitamin E may affect the ability of either photocoagulation method to reduce retinal thickening, or vice versa?
Is there evidence that celecoxib may inhibit retinal thickening?
What are the estimated treatment effects on vision?
Is the number of laser treatments required to achieve a reduction in retinal thickening similar across treatment groups?
A tertiary objective of this study will be to examine the effects of dramatically reducing low-density lipoproteins cholesterol in patients with diabetic macular edema and elevated serum lipids. Change vision and retinal thickness will be compared across three groups; (1) patients without elevated serum lipids at baseline, (2) patients with elevated lipids at baseline and receive standard of care treatment, and (3) patients with elevated lipids at baseline and are aggressively treated pharmacologically.
Tarehe
| Imethibitishwa Mwisho: | 11/30/2002 |
| Iliyowasilishwa Kwanza: | 11/28/2001 |
| Uandikishaji uliokadiriwa Uliwasilishwa: | 11/28/2001 |
| Iliyotumwa Kwanza: | 11/29/2001 |
| Sasisho la Mwisho Liliwasilishwa: | 03/02/2008 |
| Sasisho la Mwisho Lilichapishwa: | 03/03/2008 |
| Tarehe halisi ya kuanza kwa masomo: | 10/31/2001 |
| Tarehe ya Kukamilisha Utafiti: | 11/30/2002 |
Hali au ugonjwa
Uingiliaji / matibabu
Drug: Vitamin E
Awamu
Vigezo vya Kustahiki
| Jinsia Inastahiki Kujifunza | All |
| Hupokea Wajitolea wa Afya | Ndio |
| Vigezo | INCLUSION CRITERIA: Patients with type 1 or 2 diabetes. Patients with clinically significant macular edema in at least one eye. Best corrected visual acuity 20/400 or better as measured on an ETDRS chart in the eye with clinically significant macular edema; this eye will be considered the study eye. If both eyes have clinically significant macular edema and best corrected visual acuity greater than or equal to 20/400, the right eye will be considered the study eye. May have had proliferative diabetic retinopathy but scatter photocoagulation must be performed more than six months ago. Ocular media sufficiently clear to allow for quality fundus photography. If Aphakic or pseudophakic, lens removal must have occurred at least 6 months prior to enrollment. Clinical diagnosis of diabetes based on any one of the criteria (determined by medical physician): Documented history of plasma glucose value greater than 210 mg/dl on 3 different occasions. Fasting blood sugar greater than 150 mg/dl on 3 different occasions. Documented history of ketoacidosis. Insulin dependency. Documented history of abnormal glucose tolerance test. Patient's medical status must include a likelihood of survival for 5 years. Hemoglobin A1C 12 percent or less. Willingness to accept randomization for diet or drug therapy for lowering of elevated lipid levels. Understand and sign the informed consent. Patients over 18 years of age since the population of interest is primarily older than 18. A negative urine pregnancy test for women of childbearing potential. EXCLUSION CRITERIA: Retinopathy that requires scatter photocoagulation immediately. Ocular disease other than diabetic retinopathy that may confound the outcome of the study (e.g. age-related macular degeneration, drug toxicity, uveitis, etc.). Had previous focal laser photocoagulation for diabetic macular edema. Poor survival due to other systemic diseases (separate from diabetes) Poor glycemic control with hemoglobin A1C greater than 12 percent. Past or current liver disease, which precludes the use of the lipid-lowering drugs. Vitamin E supplementation over and above the amount in a multivitamin (30 IU/day) one month prior to entry into the study. History of hypersensitivity to fluorescein. History of intra-cranial bleeds. Evidence of other ocular diseases that may confound the assessment of treatment of diabetic macular edema. Prior or current macular detachment in the affected eye(s). Concurrent celebrex or any other COX-2 inhibitor within 7 days prior to baseline. Concurrent coumadin therapy or known bleeding diathesis. Concurrent treatment with a new investigational drug. Concurrent lithium therapy Malabsorption syndrome. Concurrent administration of anti-cholesterol resin medications (e.g. cholestyramine) Concurrent administration of the anti-obesity drug orlistat (Xenical). Concurrent administration of other NSAIDs. Allergy to sulphonomides, NSAIDs, or exhibit the aspirin triad. Pregnant or lactating women. Chronic requirement for any ocular medication for other diseases such as glacoma. Current history of malignancy (except patients having a basal cell carcinoma that was treated successfully, or other malignancy operated on and in remission for 5 years prior to inclusion in the trial). |
