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

Primary Purpose

Diabetic Macular Edema

Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Laser photocoagulation
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Vision Institute, Federal University of Sao PauloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Micropulse 810nm diode laser

Argon laser photocoagulation

Outcomes

Primary Outcome Measures

Macular thickness measured by optical coherence tomography (OCT)

Secondary Outcome Measures

Safety profile
Selectivity of laser therapy (autofluorescence and mfERG)

Full Information

First Posted
October 31, 2007
Last Updated
May 6, 2008
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT00552435
Brief Title
Micropulse 810 Nanomolar (nm), Diode Laser for Diffuse Diabetic Macular Edema
Official Title
Phase 2 Study of Micropulse 810nm Diode Laser Photocoagulation for Treatment of Diffuse Diabetic Macular Edema
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Unknown status
Study Start Date
March 2007 (undefined)
Primary Completion Date
November 2008 (Anticipated)
Study Completion Date
November 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Federal University of São Paulo

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Micropulse 810nm diode laser
Arm Title
2
Arm Type
Active Comparator
Arm Description
Argon laser photocoagulation
Intervention Type
Device
Intervention Name(s)
Laser photocoagulation
Intervention Description
Laser therapy is applied using a slit lamp and specific laser contact lens.
Primary Outcome Measure Information:
Title
Macular thickness measured by optical coherence tomography (OCT)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Safety profile
Time Frame
12 months
Title
Selectivity of laser therapy (autofluorescence and mfERG)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Lavinsky
Phone
55-11-7658-8669
Email
lavinsky@via-rs.net
First Name & Middle Initial & Last Name or Official Title & Degree
Jose A Cardillo
Phone
55-16-8115-1000
Email
hospitaldeolhos@uol.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose A Cardillo
Organizational Affiliation
Federal University of Sao Paulo- Department of Ophthalmology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vision Institute, Federal University of Sao Paulo
City
Sao Paulo
State/Province
SP
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Lavinsky, MD
Phone
55-11-7658-8669
First Name & Middle Initial & Last Name & Degree
Jose A Cardillo
First Name & Middle Initial & Last Name & Degree
Michel E Farah
First Name & Middle Initial & Last Name & Degree
Paulo Hilarião
First Name & Middle Initial & Last Name & Degree
Leonardo Castro
First Name & Middle Initial & Last Name & Degree
Daniel Lavinsky

12. IPD Sharing Statement

Citations:
PubMed Identifier
21345996
Citation
Lavinsky D, Cardillo JA, Melo LA Jr, Dare A, Farah ME, Belfort R Jr. Randomized clinical trial evaluating mETDRS versus normal or high-density micropulse photocoagulation for diabetic macular edema. Invest Ophthalmol Vis Sci. 2011 Jun 17;52(7):4314-23. doi: 10.1167/iovs.10-6828.
Results Reference
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Micropulse 810 Nanomolar (nm), Diode Laser for Diffuse Diabetic Macular Edema

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