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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravitreal bevacizumab injection with subthreshold micropulse laser | Combination Product | Group A: intravitreal interjection of Bevacizumab and subthreshold micropulse laser |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline visual acuity at 2 months | Change from baseline best-corrected visual acuity at 2 months | Change from baseline to 2 months |
| Change from 2 months visual acuity at 3 months | Change from 2 months best-corrected visual acuity at 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alireza Ramezani | Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ophthalmic Research Center | Tehran | Iran |
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| Intravitreal bevacizumab injection alone | Drug | Group B: Intravitreal injection of Bevacizumab alone |
|
| Change from 10 months to 12 months |
| Change from 2 months to 3 months |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |