Pilot Study of Laser Photocoagulation Therapy for Diabetic Macular Edema
|First Received Date ICMJE||September 13, 2003|
|Last Updated Date||September 26, 2015|
|Start Date ICMJE||September 2003|
|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 NCT00069056 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||Pilot Study of Laser Photocoagulation Therapy for Diabetic Macular Edema|
|Official Title ICMJE||A Pilot Study of Laser Photocoagulation for 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 and cause 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. A different laser technique, the mild macular grid, uses lighter laser burns through the macula and may be less damaging to the eye, but this is not known. This study will compare the two techniques and the information on side effects will be used to design a larger study of whether one laser is more effective than the other.
Patients 18 years of age and older with type 1 or type 2 diabetes and macular edema may be eligible for this study. Candidates will be screened with the following tests and procedures:
Participants will be randomly assigned to one of the two laser therapies in the eye with macula edema. (Patients with macular edema in both eyes will receive both treatments-one in each eye.) 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 number of treatments depends on how well they are working. Patients will return for follow-up visits 4, 8, and 12 months after the first treatment, and then every year until year 3. During the follow-up visits, the response to treatment will be evaluated with repeat tests of several of the screening exams.
The Diabetic Retinopathy Clinical Research Network (DRCRnet) was formed to conduct clinical trials and epidemiological studies for diabetic retinopathy.
As part of the establishment of the network, it is necessary to standardize data collection methods, testing procedures, and treatment techniques for use in the anticipated multiple protocols to be conducted by the network. One of the treatment techniques requiring standardization is laser photocoagulation treatment of diabetic macular edema. To accomplish this goal, a protocol has been developed to enroll patients with diabetic macular edema who require laser treatment. Procedures to be conducted by standardized protocols include refraction, visual acuity testing, fundus photography, fluorescein angiography, optical coherence tomography (OCT) and laser photocoagulation. One of the benefits from having a structured protocol will be that the outcome data using the standardized techniques can be used for sample size estimations in future protocols. This is particularly true for OCT for which we need to develop standard methods to assess changes in groups of patients and for which there are limited longitudinal data, especially in groups of patients.
The conduct of this study provides the opportunity not only to collect data on a standardized laser protocol commonly used in current clinical practice but also to collect pilot data evaluating a new laser technique. The 'current practice' laser protocol, modified from the ETDRS treatment protocol, involves focal/grid photocoagulation to areas of macular thickening with leaking MA, diffuse leakage or nonperfusion (modified-ETDRS technique). There is extensive evidence supporting the efficacy of ETDRS laser photocoagulation technique for the treatment of macular edema. The alternative technique, called mild macular grid (MMG) photocoagulation, provides mild grid treatment using small, widely separated burns to the retina from 500 to 3000 microns (3500 microns temporally) from the macular center. This technique may potentially have fewer side effects, different edema resolution rate or prevention of future development of macular edema as discussed below. The study will use randomization to assign each patient to receive one of the two treatment methods.
For this protocol, participation will be open to all clinical sites that have the requisite equipment needed for the study and to all ophthalmologists who meet criteria to be a DRCR.net investigator. The sample size for the study will be dictated by the number of participating sites, with each site limited to the enrollment of a maximum of four patients or one patient per certified investigator, whichever is greater.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 1|
|Study Design ICMJE||Primary Purpose: Treatment|
|Condition ICMJE||Diabetic Retinopathy|
|Intervention ICMJE||Procedure: Laser Treatment|
|Study Arms||Not Provided|
|Publications *||Photocoagulation for diabetic macular edema. Early Treatment Diabetic Retinopathy Study report number 1. Early Treatment Diabetic Retinopathy Study research group. Arch Ophthalmol. 1985 Dec;103(12):1796-806.|
* 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||August 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
INCLUSION AND EXCLUSION CRITERIA - STUDY EYE:
At least one eye must meet all of the following criteria:
A patient may have two "study eyes" only if both are eligible at the time of randomization. An eye that becomes eligible after randomization will not be considered a study eye for purposes of data analyses or treatment decisions although information is being gathered on all 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||NCT00069056|
|Other Study ID Numbers ICMJE||030291, 03-EI-0291|
|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||August 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP