Micropulse 810 Nanomolar (nm), Diode Laser for Diffuse Diabetic Macular Edema

May 6, 2008 updated by: Federal University of São Paulo

Phase 2 Study of Micropulse 810nm Diode Laser Photocoagulation for Treatment of Diffuse Diabetic Macular Edema

Objective: To compare micropulse 810nm diode laser photocoagulation versus argon laser photocoagulation for treatment of diabetic macular edema. Micropulse laser technique will be determined by an initial clinical trial comparing single versus double density laser photocoagulation techniques for treatment of diabetic macular edema.The single density is based on the Early Treatment Diabetic Retinopathy Study (ETDRS) grid photocoagulation technique and the double density increases the number of spots.

Methods: Patients with diabetic macular edema will be assigned to receive either micropulse 810nm diode laser photocoagulation or argon laser photocoagulation therapy. First, in a smaller clinical trial, patients will be assigned to single or double density micropulse 810nm diode laser to determine best strategy for this therapy. Visual acuity, fundus photographs and fluorescein angiography, and optical coherence tomography measurements , autofluorescence and mfERG were obtained at baseline and at 1, 3 and 6 months and 12 months.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil
        • Recruiting
        • Vision Institute, Federal University of Sao Paulo
        • Contact:
          • Daniel Lavinsky, MD
          • Phone Number: 55-11-7658-8669
        • Principal Investigator:
          • Jose A Cardillo
        • Principal Investigator:
          • Michel E Farah
        • Sub-Investigator:
          • Paulo Hilarião
        • Sub-Investigator:
          • Leonardo Castro
        • Sub-Investigator:
          • Daniel Lavinsky

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diabetes mellitus (type 1 or 2)
  • Diabetic macular edema in study eye associated to diabetic retinopathy
  • Diffuse macular edema defined as macular thickening determined by biomicroscopy and fluorescein angiography.
  • Best corrected visual acuity between 34 (20/200) and 68 letters (20/50).
  • Macular thickness greater than 300 mcm on OCT.

Exclusion Criteria:

  • Uncontrolled systemic disease
  • Start of medical therapy for diabetes or change in treatment from oral to insulin four months before initial visit.
  • HbA1c levels greater than 10%
  • Presence of retinal venous occlusion, cystoid macular edema,or other condition that would contribute to macular edema.
  • Presence of epiretinal membrane
  • Presence of vitreomacular traction in the study eye.
  • Neovascularization of disc or elsewhere in the study eye.
  • History or presence of choroidal neovascularization in the study eye.
  • Presence of rubeosis irides in the study eye.
  • Eye opacity that interfere with clinical documentation and photography.
  • Intra-ocular surgery 90 days before initial visit.
  • Scheduled surgery for study eye.
  • Patients with known allergies to fluorescein.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Micropulse 810nm diode laser
Device: Laser photocoagulation
Laser therapy is applied using a slit lamp and specific laser contact lens.
Active Comparator: 2
Argon laser photocoagulation
Device: Laser photocoagulation
Laser therapy is applied using a slit lamp and specific laser contact lens.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Macular thickness measured by optical coherence tomography (OCT)
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety profile
Time Frame: 12 months
12 months
Selectivity of laser therapy (autofluorescence and mfERG)
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Investigators

  • Principal Investigator: Jose A Cardillo, Federal University of Sao Paulo- Department of Ophthalmology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Anticipated)

November 1, 2008

Study Completion (Anticipated)

November 1, 2008

Study Registration Dates

First Submitted

October 31, 2007

First Submitted That Met QC Criteria

October 31, 2007

First Posted (Estimate)

November 2, 2007

Study Record Updates

Last Update Posted (Estimate)

May 7, 2008

Last Update Submitted That Met QC Criteria

May 6, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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