Laser and Medical Treatment of Diabetic Macular Edema
Raktažodžiai
Santrauka
apibūdinimas
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.
Using a factorial design, this study will compare (1) diode (micropulse) laser photocoagulation to mild ETDRS style focal photocoagulation and, (2) treatment with a COX-2 inhibitor (celecoxib), or placebo prior to and following laser photocoagulation. The primary outcomes are a visual acuity drop or increase of 15 letters or more from baseline to year 3. The secondary outcome is a significant reduction in macular edema, defined as a 50% reduction in thickening as measured by Optical Coherence Tomography (OCT), a two step reduction in macular thickness compared to standard stereoscopic fundus photographs, and a 50% reduction in the area of leakage as measured by fluorescein angiography. The University of Wisconsin Fundus Photography Reading Center will grade OCT, photographs, and angiograms and will be masked to treatment assignment. Other secondary outcomes will include the timing of the first required laser treatment, changes in visual acuity throughout the study, and the number of laser treatments required during the course of the study. In addition, all adverse events and abnormal laboratory values will be collected and tabulated. Specific objectives 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 celecoxib may inhibit or induce 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?
The 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 lipid levels. Change vision and retinal thickness will be compared across three groups; (1) patients without elevated serum lipids at baseline, (2) patients with elevated lipid levels at baseline and receive standard of care treatment, and (3) patients with elevated lipid levels at baseline and are aggressively treated pharmacologically.
Datos
Paskutinį kartą patikrinta: | 06/30/2006 |
Pirmasis pateikimas: | 12/08/2002 |
Numatytas registravimas pateiktas: | 12/08/2002 |
Pirmas paskelbtas: | 12/09/2002 |
Paskutinis atnaujinimas pateiktas: | 07/17/2006 |
Paskutinis atnaujinimas paskelbtas: | 07/18/2006 |
Faktinė studijų pradžios data: | 11/30/2002 |
Numatoma studijų užbaigimo data: | 06/30/2006 |
Būklė ar liga
Intervencija / gydymas
Drug: Celecoxib (Celebrex)
Fazė
Tinkamumo kriterijai
Amžius, tinkami studijuoti | 18 Years Į 18 Years |
Tinkamos studijoms lytys | All |
Priima sveikus savanorius | Taip |
Kriterijai | - INCLUSION CRITERIA: To be eligible for the study each participant must have at least one eye, which satisfies all ocular inclusion criteria: 1. Participants with type 1 or 2 diabetes. 2. Participants with clinically significant macular edema in at least one eye that requires laser treatment, but in the opinion of the Investigator, can be delayed for up to at least 3 months. 3. 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 they 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, however, both eyes will be eligible for treatment. 4. May have had proliferative diabetic retinopathy but scatter photocoagulation must have been performed more than four months ago. 5. Ocular media sufficiently clear to allow for quality fundus photography. 6. If aphakic or pseudophakic, lens removal must have occurred at least 6 months prior to enrollment. 7. Documented hemoglobin A1C 12% or less within one month of baseline. 8. Willingness to accept randomization for diet or drug therapy for lowering of elevated lipid levels (for sites participating in the Lipid Lowering study option). 9. Understand and sign the informed consent. 10. Participants 18 years of age and older since the population of interest is primarily adults. EXCLUSION CRITERIA: To be eligible for the study, each participant must not satisfy an ocular exclusion cirterion in both eyes. 1. Retinopathy that requires scatter photocoagulation immediately. 2. Ocular disease other than diabetic retinopathy that may confound the outcome of the study (e.g. age-related macular degeneration, drug toxicity, uveitis, etc.). 3. Prior of current macular detachment in the eligible eye(s). 4. Use of an investigational drug within 30 days of enrollment. 5. Malaborsorption syndrome. 6. Concurrent administration of the anti-obesity drug orlistat (Xenical). 7. Positive serum pregnancy test or currently lactating for women of childbearing potential. 8. Chronic requirement (e.g., greater than or equal to 4 weeks at a time) for ocular medication for diseases that, in the judgement of the examining physician, are vision thereateniong or may affect the primary outcome (artificial tears are permitted). 9. History of cancer and prognosis of survival of less than 3 years. 10. Participants whose diabetic macular edema, in the opinion of the Principal Investigator, cannot benefit from laser treatments, including those with subretinal fibrosis, severe macular non-perfusion, or parafoveal leakage in oth eyes. 11. Participants that have a history of focal laser treatment, and in the opinion of the investigator are thought to be refractory (e.g., > 50 micron burns or equivalent) to laser treatment or wwere treated within 3 months of baseline. 12. Participants with clear vireal-retinal tracion wiich in the opinion of the investigator needs to be treated as a contributor macular edema. 13. Participants requiriing herapy with topaical ophthalmic prostaglandin analogues. 14. Laboratory values outside normal limits and considered clinically significant by the investigator. 15. Past or current liver disease, which precludes the use of the lipid-lowering drugs. 16. Used Celebrex [Registered Trademark] or any other COX-2 inhibitor, NSAIDs, or ocular topical NSAID use great than 3 days per week for a period of 4 weeks or more within 6 months prior to enrollment, or likely need during the study (Aspirin dose of 325 mg per day is permitted). 17. Concurrent warfarin therapy or known bleeding diathesis. 18. Concurrent lithium therapy. 19. History of peptic ulcer disease within 1 year prior to enrollment. 20. History of kidney disease (serum creatinine greater than 2.5 mg/dL, or need for dialysis). 21. Allergy to sulfa- containing compounds, NSAIDs, or demonstrtion of the aspirin triad. 22. History of inflammatory bowel disease. 23. History of mycardial infarction within 2 years prior to enrollment. |