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

Diabetic Macular Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00552435
• Other study ID #: MP-001
• Status: Recruiting
• Phase: Phase 2
• First received: October 31, 2007
• Last updated: May 6, 2008
• Start date: March 2007
• Est. completion date: November 2008

Study information

• Verified date: May 2008
• Source: Federal University of São Paulo
• Contact: Daniel Lavinsky
• Phone: 55-11-7658-8669
• Email: lavinsky[@]via-rs.net
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in ResearchBrazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Device:
• Laser photocoagulation
Laser therapy is applied using a slit lamp and specific laser contact lens.

Locations

Country	Name	City	State
Brazil	Vision Institute, Federal University of Sao Paulo	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Macular thickness measured by optical coherence tomography (OCT)		12 months	No
Secondary	Safety profile		12 months	Yes
Secondary	Selectivity of laser therapy (autofluorescence and mfERG)		12 months	Yes