Additional Effect of Subthreshold Micropulse Laser to Intravitreous Injection of Bevacizumab on Diabetic Macular Edema
NCT ID: NCT05582577
Last Updated: 2022-10-17
Study Results
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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UNKNOWN
PHASE2/PHASE3
30 participants
INTERVENTIONAL
2022-10-15
2023-12-15
Brief Summary
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A subthreshold micropulse laser will be performed after the third injection in group A and a sham laser will be performed after the third injection in group B. Then, the intravitreal injection of Bevacizumab will be continued if the central thickness of the macula is equal to or greater than 300 microns.
The follow-up will be performed 2, 3, 4, 6, 8, 10, and 12 months after the first injection. In each follow-up (except for the first month), ophthalmological examinations and Optical Coherence Tomography will be performed.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Simultaneous intravitreal bevacizumab injection with subthreshold micropulse laser
After the eye examination, the eyes will be randomly divided into 2 groups {group A: intravitreal interjection of Bevacizumab and subthreshold micropulse laser, and group B: intravitreal injection of Bevacizumab alone}. For both groups, 3 intravitreal injections of bevacizumab with a dose of 1.25 mg will be performed, in sterile conditions at 1-month intervals as a loading dose.
A subthreshold micropulse laser will be performed after the third injection in group A. Then, the intravitreal injection of Bevacizumab will be continued if the central thickness of the macula is equal to or greater than 300 microns.
The follow-up will be performed 2, 3, 4, 6, 8, 10, and 12 months after the first injection. In each follow-up (except for the first month), ophthalmological examinations and Optical Coherence Tomography will be performed.
Intravitreal bevacizumab injection with subthreshold micropulse laser
Group A: intravitreal interjection of Bevacizumab and subthreshold micropulse laser
Intravitreal bevacizumab injection alone
After the eye examination, the eyes will be randomly divided into 2 groups {group A: intravitreal interjection of Bevacizumab and subthreshold micropulse laser, and group B: intravitreal injection of Bevacizumab alone}. For both groups, 3 intravitreal injections of bevacizumab with a dose of 1.25 mg will be performed, in sterile conditions at 1-month intervals as a loading dose.
A sham laser will be performed after the third injection in group B. Then, the intravitreal injection of Bevacizumab will be continued if the central thickness of the macula is equal to or greater than 300 microns.
The follow-up will be performed 2, 3, 4, 6, 8, 10, and 12 months after the first injection. In each follow-up (except for the first month), ophthalmological examinations and Optical Coherence Tomography will be performed.
Intravitreal bevacizumab injection alone
Group B: Intravitreal injection of Bevacizumab alone
Interventions
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Intravitreal bevacizumab injection with subthreshold micropulse laser
Group A: intravitreal interjection of Bevacizumab and subthreshold micropulse laser
Intravitreal bevacizumab injection alone
Group B: Intravitreal injection of Bevacizumab alone
Eligibility Criteria
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Inclusion Criteria
* Center-involved diabetic macular edema
* Mean central subfield thickness \>300 micrometers
* Best-corrected visual acuity between 20/40 and 20/400
Exclusion Criteria
* High-risk proliferative diabetic retinopathy
* Prior treatment with intravitreal or peribulbar injections within the preceding 3 months
* History of panretinal photocoagulation within the former 4 months
* History of macular photocoagulation
* Hx of Intraocular surgery (except cataract extraction)
* cataract extraction less than 6 months ago
* Macular edema due to a cause other than diabetic retinopathy
* Any other ocular condition that visual acuity would not improve from the resolution of the edema (eg, foveal atrophy)
* Substantial cataract estimated to have reduced visual acuity by \>3 lines
* uveitis, neovascular glaucoma, exudative age-related macular degeneration, high risk proliferative diabetic retinopathy
* vitreomacular traction or epiretinal membrane
* uncontrolled glaucoma ( \> 30 millimeters of mercury with anti-glaucoma medications)
* Not having: Media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus photographs
18 Years
40 Years
ALL
No
Sponsors
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Shahid Beheshti University of Medical Sciences
OTHER
Responsible Party
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Zahra Rabbani Khah
Head of Ophthalmic Research Center
Principal Investigators
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Alireza Ramezani
Role: PRINCIPAL_INVESTIGATOR
Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences
Locations
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Ophthalmic Research Center
Tehran, , Iran
Countries
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Other Identifiers
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14016
Identifier Type: -
Identifier Source: org_study_id
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