Full Text View
Tabular View
No Study Results Posted
Related Studies
The Course of Response to Focal Photocoagulation for DME (Laser Resp)
This study has been completed.

First Received on February 27, 2007.   Last Updated on March 18, 2011   History of Changes
Sponsor: Diabetic Retinopathy Clinical Research Network
Collaborator: National Eye Institute (NEI)
Information provided by: Diabetic Retinopathy Clinical Research Network
ClinicalTrials.gov Identifier: NCT00442156
  Purpose

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.


Condition Intervention
Diabetic Retinopathy
Diabetic Macular Edema
Procedure: Laser photocoagulation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Course of Response to Focal Photocoagulation for Diabetic Macular Edema

Resource links provided by NLM:


Further study details as provided by Diabetic Retinopathy Clinical Research Network:

Primary Outcome Measures:
  • OCT-measured retinal thickness and visual acuity [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 122
Study Start Date: January 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Laser
People with diabetic macular edema involving the center of the macula (OCT central subfield thickness >250 microns), who were already intended to receive focal photocoagulation
Procedure: Laser photocoagulation
modified ETDRS focal photocoagulation generally completed in a single sitting on the day of enrollment, but if little or no improvement, may be repeated at 16 weeks
Other Name: Laser

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Diabetics within the United States who are at least 18 years old and have DME treatable with laser photocoagulation.

Criteria

Inclusion Criteria

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

Exclusion Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00442156

  Show 32 Study Locations
Sponsors and Collaborators
Diabetic Retinopathy Clinical Research Network
Investigators
Study Chair: David Browning, M.D. Charlotte Eye, Ear, Nose and Throat Assoc., PA
  More Information

Additional Information:
Publications:
Responsible Party: Roy W. Beck, M.D., Ph.D., Director, Jaeb Center for Health Research (DRCR.net)
ClinicalTrials.gov Identifier: NCT00442156     History of Changes
Other Study ID Numbers: NEI-131, U10EY018817-03, U10EY014229-07, U10EY014231-09
Study First Received: February 27, 2007
Last Updated: March 18, 2011
Health Authority: United States: Federal Government

Keywords provided by Diabetic Retinopathy Clinical Research Network:
Laser photocoagulation

Additional relevant MeSH terms:
Diabetic Retinopathy
Edema
Macular Edema
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Signs and Symptoms
Macular Degeneration
Retinal Degeneration

ClinicalTrials.gov processed this record on February 09, 2012