Laser and Medical Treatment of Diabetic Macular Edema
|First Received Date ICMJE||December 9, 2002|
|Last Updated Date||July 18, 2006|
|Start Date ICMJE||December 2002|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00050479 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Laser and Medical Treatment of Diabetic Macular Edema|
|Official Title ICMJE||Preliminary Multi-Center Assessment of Laser and Medical Treatment of Diabetic Macular Edema|
This study will compare the side effects of two laser treatments for diabetic macular edema, a common condition in patients with diabetes. In macular edema, blood vessels in the retina, a thin layer of tissue that lines the back of the eye become leaky and the retina swells. The macula, the center part of the retina that is responsible for fine vision may also swell, causing vision loss. Traditional laser treatment (argon blue or green or yellow) for macular swelling, or edema, causes scarring that can expand and possibly lead to more loss of vision. Studies with a different type of laser (diode) may be less damaging. The results of this study on side effects of the treatments will be used to design a larger study of effectiveness. This study will also examine whether celecoxib (Celebrex® (Registered Trademark)), an anti-arthritis drug that reduces inflammation and swelling, can reduce inflammation and swelling of the retina. Patients with elevated cholesterol levels will be invited to participate in a cholesterol reduction part of the study to compare normal-pace cholesterol reduction with accelerated reduction.
Patients 18 years of age and older with type 1 or type 2 diabetes and macular edema that requires laser treatment may be eligible for this study. Candidates will be screened with the following tests and procedures:
Participants will be randomly assigned to take celecoxib or placebo (an inactive, look-alike pill). Participants who have elevated cholesterol levels may return for a brief visit after 1 month. All patients will return for follow-up visits at 3, 6, and 12 months. Patients who require laser treatment will be randomly assigned to one of the two laser treatments. For these procedures, eye drops are put in the eye to numb the surface and a contact lens is placed on the eye during the laser beam application. Several visits may be required for additional laser treatments. The maximum number of treatments depends on how well the treatment is working. Patients who respond well to the study medication may receive no laser treatments. After the first year, patients will be followed every 6 months until either the patient returns for a 3-year visit, the last enrolled patient returns for the 1-year visit, or the patient requests to leave the study. During the follow-up visits, patients' response to treatment will be evaluated with repeat tests of several of the screening exams.
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:
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.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Primary Purpose: Treatment|
|Condition ICMJE||Macular Degeneration|
|Intervention ICMJE||Drug: Celecoxib (Celebrex)|
|Study Arms||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Completion Date||July 2006|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
To be eligible for the study each participant must have at least one eye, which satisfies all ocular inclusion criteria:
To be eligible for the study, each participant must not satisfy an ocular exclusion cirterion in both eyes.
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00050479|
|Other Study ID Numbers ICMJE||030065
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Eye Institute (NEI)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||July 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP