The Course of Response to Focal Photocoagulation for DME

Completed

Conditions studied: Diabetic Retinopathy, Diabetic Macular Edema

In brief

The study objective is to determine the course of changes in OCT measured macular thickness and visual acuity following a single session of focal photocoagulation for center-involved DME. The response will be evaluated separately in eyes with and without prior focal photocoagulation for DME. The purpose is to determine the proportion of eyes that continue to improve at least 5 letters in visual acuity or at least 10% in central retinal thickness after a session of focal photocoagulation. In addition, the study will explore whether any baseline factors can be identified that are predictive of the response. All subjects will have follow-up visits 8 weeks and 16 weeks post treatment. At the 16-week visit, study eyes are evaluated for change in retinal thickness and visual acuity from baseline. * Treatment is to be deferred and follow up continued if visual acuity letter score has improved by \>5 or OCT central subfield thickness has decreased by \>10% compared with baseline. * If visual acuity letter score has not improved by at least 5 and OCT central subfield thickness has not decreased by at least 10%, then the eye is classified as 'not improved' and the investigator may provide additional treatment. Follow up ends for eyes that receive additional treatment at this visit. However, if the investigator and participant elect to defer additional treatment (even if deferral criteria are not met), then follow up will continue until the study eye receives additional treatment for DME. * Eyes continuing in follow up have visits every 8 weeks (+1week) as long as there has been continued improvement in visual acuity (letter score improved \>5 ) or retinal thickness (central subfield thickness decreased by \>10%) compared with the visit 16 weeks earlier. The longest follow-up time will be 48 weeks. By providing information on the length of time during which clinically meaningful improvement occurs following focal photocoagulation, clinicians will be better able to determine when further photocoagulation or other treatments should be considered for persistent DME. Depending on the results of this study, a future randomized clinical trial will be considered comparing the more aggressive retreatment photocoagulation regimen currently serving as the standard DRCR Network approach to focal photocoagulation for macular edema with the less aggressive regimen evaluated in this protocol.

Key facts

Study ID: NCT00442156
Run by: Jaeb Center for Health Research
People needed: 122
Starts: 2007-01-01
Expected to finish: 2008-06-01
Last updated by the study team: 2016-08-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

To be eligible, the following inclusion criteria must be met:
Age >= 18 years
Diagnosis of diabetes mellitus (type 1 or type 2.
At least one eye meets the study eye criteria.
Able and willing to provide informed consent.
The subject must have one eye meeting all of the inclusion criteria and none of the exclusion criteria listed below. If both eyes are eligible, the study eye is selected by the investigator and subject.
Best corrected E-ETDRS visual acuity letter score >= 24 (i.e., 20/320 or better) within 8 days of enrollment.
On clinical exam, definite retinal thickening due to diabetic macular edema involving the center of the macula.
OCT central subfield >=250 microns within 8 days of enrollment.
Media clarity, pupillary dilation, and subject cooperation sufficient for adequate OCT.
Investigator believes that focal photocoagulation is the most appropriate treatment for the DME.
Study Eye Exclusion Criteria

You may not qualify if…

A subject is not eligible if any of the following exclusion criteria are present:
Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
Blood pressure > 180/110 (systolic above 180 OR diastolic above 110).
Participation in an investigational trial within 30 days of enrollment that involved treatment with any drug that has not received regulatory approval at the time of study entry.
Subject is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the next 6 months.
The following exclusions apply to the study eye only (i.e., they may be present for the nonstudy eye):
Macular edema is considered to be due to a cause other than diabetic macular edema.
An ocular condition is present such that, in the opinion of the investigator, visual acuity loss would not improve from resolution of macular edema (e.g., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, significant macular ischemia, nonretinal condition).
An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, etc.).
Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (i.e., cataract would be reducing acuity to 20/40 or worse if eye was otherwise normal).
History of treatment for DME at any time in the past 4 months (such as focal/grid macular photocoagulation, intravitreal or peribulbar corticosteroids, anti-VEGF drugs, or any other treatment).
History of panretinal (scatter) photocoagulation (PRP) within 4 months prior to enrollment or anticipated to be performed within next 6 months.
History of major ocular surgery (including vitrectomy, cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months.
History of YAG capsulotomy performed within 2 months prior to enrollment

Where it is running

Southern California Desert Retina Consultants, MC — Palm Springs, California, United States
Retina Vitreous Consultants — Fort Lauderdale, Florida, United States
Retina Consultants of Southwest Florida — Fort Myers, Florida, United States
Central Florida Retina Institute — Lakeland, Florida, United States
Southeast Retina Center, P.C. — Augusta, Georgia, United States
Retina Associates of Hawaii, Inc. — Honolulu, Hawaii, United States
Raj K. Maturi, M.D., P.C. — Indianapolis, Indiana, United States
American Eye Institute — New Albany, Indiana, United States
Retina and Vitreous Associates of Kentucky — Lexington, Kentucky, United States
Paducah Retinal Center — Paducah, Kentucky, United States
Maine Vitreoretinal Consultants — Bangor, Maine, United States
Elman Retina Group, P.A. — Baltimore, Maryland, United States
Southern New England Retina Associates — Attleboro, Massachusetts, United States
Ophthalmic Consultants of Boston — Boston, Massachusetts, United States
Joslin Diabetes Center — Boston, Massachusetts, United States
Vitreo-Retinal Associates — Grand Rapids, Michigan, United States
Associated Retina Consultants — Williamsburg, Michigan, United States
Delaware Valley Retina Associates — Lawrenceville, New Jersey, United States
University of Rochester — Rochester, New York, United States
Retina-Vitreous Surgeons of Central New York, PC — Syracuse, New York, United States
University of North Carolina, Dept. of Ophthalmology — Chapel Hill, North Carolina, United States
Charlotte Eye, Ear, Nose and Throat Assoc., PA — Charlotte, North Carolina, United States
Retina Associates of Cleveland, Inc. — Beachwood, Ohio, United States
Casey Eye Institute — Portland, Oregon, United States
Palmetto Retina Center — Columbia, South Carolina, United States

Full record on ClinicalTrials.gov

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