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

Diabetic Macular Edema Clinical Trial

Official title:

Additional Effect of Sub-threshold Micro-pulse Laser to Intra-vitreous Injection of Bevacizumab on Diabetic Macular Edema: A Randomized Double-blinded Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05582577
• Other study ID #: 14016
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: October 15, 2022
• Est. completion date: December 15, 2023

Study information

• Verified date: October 2022
• Source: Shahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 15, 2023
• Est. primary completion date: October 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Combination Product:
• Intravitreal bevacizumab injection with subthreshold micropulse laser
Group A: intravitreal interjection of Bevacizumab and subthreshold micropulse laser

Drug:
• Intravitreal bevacizumab injection alone
Group B: Intravitreal injection of Bevacizumab alone

Locations

Country	Name	City	State
Iran, Islamic Republic of	Ophthalmic Research Center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline central macular thickness at 2 months	Change from baseline central macular thickness at 2 months using Optical Coherence Tomography	Change from baseline to 2 months
Primary	Change from 2 months central macular thickness at 3 months	Change from 2 months central macular thickness at 3 months using Optical Coherence Tomography	Change from 2 months to 3 months
Primary	Change from 3 months central macular thickness at 4 months	Change from 3 months central macular thickness at 4 months using Optical Coherence Tomography	Change from 3 months to 4 months
Primary	Change from 4 months central macular thickness at 6 months	Change from 4 months central macular thickness at 6 months using Optical Coherence Tomography	Change from 4 months to 6 months
Primary	Change from 6 months central macular thickness at 8 months	Change from 6 months central macular thickness at 8 months using Optical Coherence Tomography	Change from 6 months to 8 months
Primary	Change from 8 months central macular thickness at 10 months	Change from 8 months central macular thickness at 10 months using Optical Coherence Tomography	Change from 8 months to 10 months
Primary	Change from 10 months central macular thickness at 12 months	Change from 10 months central macular thickness at 12 months using Optical Coherence Tomography	Change from 10 months to 12 months
Secondary	Change from baseline visual acuity at 2 months	Change from baseline best-corrected visual acuity at 2 months	Change from baseline to 2 months
Secondary	Change from 2 months visual acuity at 3 months	Change from 2 months best-corrected visual acuity at 3 months	Change from 2 months to 3 months
Secondary	Change from 3 months visual acuity at 4 months	Change from 3 months best-corrected visual acuity at 4 months	Change from 3 months to 4 months
Secondary	Change from 4 months visual acuity at 6 months	Change from 4 months best-corrected visual acuity at 6 months	Change from 4 months to 6 months
Secondary	Change from 6 months visual acuity at 8 months	Change from 6 months best-corrected visual acuity at 8 month	Change from 6 months to 8 months
Secondary	Change from 8 months visual acuity at 10 months	Change from 8 months best-corrected visual acuity at 10 months	Change from 8 months to 10 months
Secondary	Change from 10 months visual acuity at 12 months	Change from 10 months best-corrected visual acuity at 12 months	Change from 10 months to 12 months