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

NCT05582577 | Unknown Phase 2

• 1 other identifier: 14016
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (7)

• Change from baseline visual acuity at 2 months

  Change from baseline to 2 months

• Change from 2 months visual acuity at 3 months

  Change from 2 months to 3 months

• Change from 3 months visual acuity at 4 months

  Change from 3 months to 4 months

• Change from 4 months visual acuity at 6 months

  Change from 4 months to 6 months

• Change from 6 months visual acuity at 8 months

  Change from 6 months to 8 months

Study Arms (2)

Simultaneous intravitreal bevacizumab injection with subthreshold micropulse laser

EXPERIMENTAL

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.

Combination Product: Intravitreal bevacizumab injection with subthreshold micropulse laser

Intravitreal bevacizumab injection alone

ACTIVE COMPARATOR

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.

Drug: Intravitreal bevacizumab injection alone

Interventions

Intravitreal bevacizumab injection with subthreshold micropulse laser COMBINATION_PRODUCT

Group A: intravitreal interjection of Bevacizumab and subthreshold micropulse laser

Simultaneous intravitreal bevacizumab injection with subthreshold micropulse laser

Intravitreal bevacizumab injection alone DRUG

Group B: Intravitreal injection of Bevacizumab alone

Intravitreal bevacizumab injection alone

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \> 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

Ophthalmic Research Center

Tehran, Iran

Location

Study Officials

• Alireza Ramezani

  Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Ophthalmic Research Center

Study Record Dates

• First Submitted: September 10, 2022
• First Posted: October 17, 2022
• Study Start: October 15, 2022
• Primary Completion: October 15, 2023
• Study Completion: December 15, 2023
• Last Updated: October 17, 2022

Record last verified: 2022-10

Locations

IR (1)