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

Primary Purpose

Diabetic Macular Edema

Status

Active

Phase

Phase 2

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Intravitreal bevacizumab injection with subthreshold micropulse laser

Intravitreal bevacizumab injection alone

About this trial

This is an interventional treatment trial for Diabetic Macular Edema

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept 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

Sites / Locations

Ophthalmic Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Simultaneous intravitreal bevacizumab injection with subthreshold micropulse laser

Intravitreal bevacizumab injection alone

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change from baseline central macular thickness at 2 months

Change from baseline central macular thickness at 2 months using Optical Coherence Tomography

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 3 months central macular thickness at 4 months

Change from 3 months central macular thickness at 4 months using Optical Coherence Tomography

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 6 months central macular thickness at 8 months

Change from 6 months central macular thickness at 8 months using Optical Coherence Tomography

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 10 months central macular thickness at 12 months

Change from 10 months central macular thickness at 12 months using Optical Coherence Tomography

Secondary Outcome Measures

Change from baseline visual acuity at 2 months

Change from baseline best-corrected visual acuity at 2 months

Change from 2 months visual acuity at 3 months

Change from 2 months best-corrected visual acuity at 3 months

Change from 3 months visual acuity at 4 months

Change from 3 months best-corrected visual acuity at 4 months

Change from 4 months visual acuity at 6 months

Change from 4 months best-corrected visual acuity at 6 months

Change from 6 months visual acuity at 8 months

Change from 6 months best-corrected visual acuity at 8 month

Change from 8 months visual acuity at 10 months

Change from 8 months best-corrected visual acuity at 10 months

Change from 10 months visual acuity at 12 months

Change from 10 months best-corrected visual acuity at 12 months

Full Information

NCT ID

NCT05582577

First Posted

September 10, 2022

Last Updated

October 14, 2022

Sponsor

Shahid Beheshti University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT05582577

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 15, 2022 (Actual)

Primary Completion Date

October 15, 2023 (Anticipated)

Study Completion Date

December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shahid Beheshti University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Macular Edema

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Simultaneous intravitreal bevacizumab injection with subthreshold micropulse laser

Arm Type

Experimental

Arm Description

Arm Title

Intravitreal bevacizumab injection alone

Arm Type

Active Comparator

Arm 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.

Intervention Type

Combination Product

Intervention Name(s)

Intravitreal bevacizumab injection with subthreshold micropulse laser

Intervention Description

Group A: intravitreal interjection of Bevacizumab and subthreshold micropulse laser

Intervention Type

Drug

Intervention Name(s)

Intravitreal bevacizumab injection alone

Intervention Description

Group B: Intravitreal injection of Bevacizumab alone

Primary Outcome Measure Information:

Title

Change from baseline central macular thickness at 2 months

Description

Change from baseline central macular thickness at 2 months using Optical Coherence Tomography

Time Frame

Change from baseline to 2 months

Title

Change from 2 months central macular thickness at 3 months

Description

Change from 2 months central macular thickness at 3 months using Optical Coherence Tomography

Time Frame

Change from 2 months to 3 months

Title

Change from 3 months central macular thickness at 4 months

Description

Change from 3 months central macular thickness at 4 months using Optical Coherence Tomography

Time Frame

Change from 3 months to 4 months

Title

Change from 4 months central macular thickness at 6 months

Description

Change from 4 months central macular thickness at 6 months using Optical Coherence Tomography

Time Frame

Change from 4 months to 6 months

Title

Change from 6 months central macular thickness at 8 months

Description

Change from 6 months central macular thickness at 8 months using Optical Coherence Tomography

Time Frame

Change from 6 months to 8 months

Title

Change from 8 months central macular thickness at 10 months

Description

Change from 8 months central macular thickness at 10 months using Optical Coherence Tomography

Time Frame

Change from 8 months to 10 months

Title

Change from 10 months central macular thickness at 12 months

Description

Change from 10 months central macular thickness at 12 months using Optical Coherence Tomography

Time Frame

Change from 10 months to 12 months

Secondary Outcome Measure Information:

Title

Change from baseline visual acuity at 2 months

Description

Change from baseline best-corrected visual acuity at 2 months

Time Frame

Change from baseline to 2 months

Title

Change from 2 months visual acuity at 3 months

Description

Change from 2 months best-corrected visual acuity at 3 months

Time Frame

Change from 2 months to 3 months

Title

Change from 3 months visual acuity at 4 months

Description

Change from 3 months best-corrected visual acuity at 4 months

Time Frame

Change from 3 months to 4 months

Title

Change from 4 months visual acuity at 6 months

Description

Change from 4 months best-corrected visual acuity at 6 months

Time Frame

Change from 4 months to 6 months

Title

Change from 6 months visual acuity at 8 months

Description

Change from 6 months best-corrected visual acuity at 8 month

Time Frame

Change from 6 months to 8 months

Title

Change from 8 months visual acuity at 10 months

Description

Change from 8 months best-corrected visual acuity at 10 months

Time Frame

Change from 8 months to 10 months

Title

Change from 10 months visual acuity at 12 months

Description

Change from 10 months best-corrected visual acuity at 12 months

Time Frame

Change from 10 months to 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alireza Ramezani

Organizational Affiliation

Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ophthalmic Research Center

City

Tehran

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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