Additional Effect of Subthreshold Micropulse Laser to Intravitreous Injection of Bevacizumab on Diabetic Macular Edema

Shahid Beheshti University of Medical Sciences

Status and phase: Active, not recruiting; Phase 3; Phase 2

Conditions: Diabetic Macular Edema

Treatments: Drug: Intravitreal bevacizumab injection alone; Combination Product: Intravitreal bevacizumab injection with subthreshold micropulse laser

Study type: Interventional

Funder types: Other

Identifiers

NCT05582577

14016 (Other Identifier)

Details and patient eligibility

About

In this study, all eyes with diabetic macular edema who meet the inclusion criteria and do not meet the exclusion criteria will be included. 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 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• > 18 years diabetic patients
• Center-involved diabetic macular edema
• Mean central subfield thickness >300 micrometers
• Best-corrected visual acuity between 20/40 and 20/400

Exclusion criteria

• hemoglobin A1c > 8
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Simultaneous intravitreal bevacizumab injection with subthreshold micropulse laser

Experimental group

Description:

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.

Treatment:

Combination Product: Intravitreal bevacizumab injection with subthreshold micropulse laser

Intravitreal bevacizumab injection alone

Active Comparator group

Description:

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.

Treatment:

Drug: Intravitreal bevacizumab injection alone