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Prospective, Randomized Clinical Trial Comparing Macular Photocoagulation With or Without Intravitreal Bevacizumab or Triamcinolone for the Treatment of Diabetic Macular Edema

NCT ID: NCT02310295

Last Updated: 2014-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2012-12-31

Brief Summary

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Purpose: To compare the effects of macular photocoagulation with or without intravitreal bevacizumab (IVB) or triamcinolone (IVTA) for the treatment of diabetic macular edema (DME). Casuistic and Methods: 58 eyes of 44 patients with diffuse DME were randomized to receive either IVB + focal/grid laser (IVB-Laser, n=19), IVTA + focal/grid laser (IVTA-Laser, n=16) or focal/grid laser alone (Laser, n=23). Ophthalmic evaluation, including best-corrected visual acuity (BCVA), intraocular pressure (IOP) and central macular thickness (CMT) were performed at baseline and monthly for 12 months.

Detailed Description

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Conditions

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Diabetic Macular Edema

Keywords

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Diabetic retinopathy Macular edema Anti-VEGF Triamcinolone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IVB-Laser

Intravitreal Bevacizumab combined with focal laser therapy

Group Type ACTIVE_COMPARATOR

Laser

Intervention Type DEVICE

focal macular laser therapy

Bevacizumab

Intervention Type DRUG

Intravitreal injection of Bevacizumab

IVTA-Laser

Intravitreal Triamcinolone combined with focal laser therapy

Group Type ACTIVE_COMPARATOR

Laser

Intervention Type DEVICE

focal macular laser therapy

Triamcinolone Acetonide

Intervention Type DRUG

Intravitreal injection of Triamcinolone Acetonide

Laser

focal laser therapy

Group Type ACTIVE_COMPARATOR

Laser

Intervention Type DEVICE

focal macular laser therapy

Interventions

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Laser

focal macular laser therapy

Intervention Type DEVICE

Bevacizumab

Intravitreal injection of Bevacizumab

Intervention Type DRUG

Triamcinolone Acetonide

Intravitreal injection of Triamcinolone Acetonide

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. clinically significant diabetic macular edema (DME) with diffuse leakage involving the center of the fovea, with DME greater than 275 microns in OCT examination
2. BCVA between 0.3 LogMAR (logarithm of smaller angle of visual resolution) (20/40) and 1.6 LogMAR (20/800)
3. signed of inform Consent.

Exclusion Criteria

1. HbA1c levels greater than 10%
2. thromboembolic event history (including myocardial infarction and stroke)
3. vitreo-macular traction on OCT
4. coagulation disorders
5. macular ischemia on fluorescein angiography examination
6. proliferative diabetic retinopathy that required treatment
7. eye surgery
8. history of ocular hypertension or glaucoma
9. any ocular pathology which in the opinion of the investigator, could macular edema or change the visual acuity during the study period (for example, retinal vascular occlusion, uveitis or other inflammatory eye disease, neovascular glaucoma)
10. systemic corticosteroid therapy
11. any conditions that could affect the documentation
12. any previous treatment for diabetic macular edema.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Andre Messias

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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12029-2008

Identifier Type: -

Identifier Source: org_study_id