A Pilot Study of Laser Photocoagulation for Diabetic Macular Edema

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Diabetic Retinopathy Clinical Research Network
ClinicalTrials.gov Identifier:
NCT00071773
First received: October 30, 2003
Last updated: March 18, 2011
Last verified: March 2011
  Purpose

This pilot study will compare the use of current laser treatment for diabetic macular edema with a similar laser treatment that is milder in intensity, but more extensive.


Condition Intervention Phase
Diabetic Macular Edema
Procedure: modified-ETDRS photocoagulation
Procedure: Mild Macular Grid photocoagulation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Study of Laser Photocoagulation for Diabetic Macular Edema

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change in the central subfield of the ETDRS grid measured by OCT. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in visual acuity [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
  • Change in area of retinal thickening on fundus photographs [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Enrollment: 263
Study Start Date: July 2003
Study Completion Date: February 2008
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Modified Early Treatment Diabetic Retinopathy Study (ETDRS)
modified-ETDRS
Procedure: modified-ETDRS photocoagulation
A treatment session can be given in single or multiple sittings at the investigator's discretion, as long as the entire treatment session is completed within 6 weeks. Retreatment in Phase 1 of the study should only occur at the 3.5 and 8 month visits.
Other Name: focal/grid photocoagulation
Active Comparator: Mild Macular Grid (MMG)
MMG technique
Procedure: Mild Macular Grid photocoagulation
A treatment session can be given in single or multiple sittings at the investigator's discretion, as long as the entire treatment session is completed within 6 weeks. Retreatment in Phase 1 of the study should only occur at the 3.5 and 8 month visits.
Other Name: mmg photocoagulation

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >= 18 years. Patients <18 years old are not being included because diabetic macular edema (DME) is so rare in this age group that the diagnosis of DME may be questionable.
  • Diagnosis of diabetes mellitus (type 1 or type 2)
  • Any one of the following will be considered to be sufficient evidence that diabetes is present:

Current regular use of insulin for the treatment of diabetes; Current regular use of oral antihyperglycemia agents for the treatment of diabetes; Documented diabetes by ADA guidelines (see DRCR.net Procedures Manual).

  • No history of renal failure requiring dialysis or renal transplant.
  • No condition that in the opinion of the investigator would preclude participation in the study (e.g., unstable medical status including blood pressure and glycemic control; Patients in poor glycemic control who recently initiated intensive insulin treatment (a pump or multiple daily injections) or plan to do so in the next 3 months should not be enrolled.
  • Ability and willingness to provide informed consent.
  • No expectation that subject will be moving out of the area of the clinical center to an area not covered by another clinical center during the next 12 months.

Study Eye Criteria:

At least one eye must meet all of the following criteria:

  • Best corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity score >= 19 letters (approximately 20/400 or better).
  • Definite retinal thickening due to diabetic macular edema based on clinical exam at or within 500 microns of the macular center for which the investigator believes laser photocoagulation is indicated.
  • A thickness of 250 microns or more in the central subfield OR a thickness of 300 microns or more in any one of the four subfields directly adjacent to the central subfield on optical coherence tomography (OCT).
  • No prior focal/grid laser photocoagulation in the macula.
  • No prior medical treatment for DME (e.g., intravitreal/peribulbar steroids).
  • No panretinal scatter photocoagulation (PRP) within prior 4 months.
  • No anticipated need for PRP within next 4 months.
  • No major ocular surgery (including cataract extraction, any other intraocular surgery, scleral buckle, glaucoma filter, cornea transplant, etc.) within prior 6 months.
  • No Nd:YAG laser capsulotomy within prior 2 months.
  • Macular edema is not considered to be due to a cause other than diabetic macular edema. An eye should not be considered eligible (1) if the macular edema is considered to be related to cataract extraction or (2) clinical exam and/or OCT suggests that vitreoretinal interface disease (eg. vitreo-retinal traction or epriretinal membrane) is the primary cause of the macular edema.
  • Media clarity, pupillary dilation, and patient cooperation sufficient for adequate fundus photos.
  • No ocular condition (other than diabetes) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the first 12 months of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass Syndrome).
  • Glaucoma per se is not an exclusion.

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)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00071773

Sponsors and Collaborators
Diabetic Retinopathy Clinical Research Network
Investigators
Study Chair: Donald S. Fong, MD, PhD Kaiser Permanente Southern California
  More Information

Publications:

Responsible Party: Roy W. Beck, M.D., Ph.D., Director, Jaeb Center for Health Research (DRCR.net)
ClinicalTrials.gov Identifier: NCT00071773     History of Changes
Other Study ID Numbers: NEI-113, U10EY018817-03, U10EY014229-07, U10EY014231-09
Study First Received: October 30, 2003
Last Updated: March 18, 2011
Health Authority: United States: Federal Government

Keywords provided by Diabetic Retinopathy Clinical Research Network:
diabetic macular edema
laser photocoagulation
etdrs
macular grid photocoagulation
DME

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on October 19, 2014