Clinical trial NCT05582577: 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
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Diabetic Macular Edema
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2022-10-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change from baseline central macular thickness at 2 months
timeFrame: Change from baseline to 2 months
measure: Change from 2 months central macular thickness at 3 months
timeFrame: Change from 2 months to 3 months
measure: Change from 3 months central macular thickness at 4 months
timeFrame: Change from 3 months to 4 months
measure: Change from 4 months central macular thickness at 6 months
timeFrame: Change from 4 months to 6 months
measure: Change from 6 months central macular thickness at 8 months
timeFrame: Change from 6 months to 8 months
measure: Change from 8 months central macular thickness at 10 months
timeFrame: Change from 8 months to 10 months
measure: Change from 10 months central macular thickness at 12 months
timeFrame: Change from 10 months to 12 months
Secondary outcomes:
measure: Change from baseline visual acuity at 2 months
timeFrame: Change from baseline to 2 months
measure: Change from 2 months visual acuity at 3 months
timeFrame: Change from 2 months to 3 months
measure: Change from 3 months visual acuity at 4 months
timeFrame: Change from 3 months to 4 months
measure: Change from 4 months visual acuity at 6 months
timeFrame: Change from 4 months to 6 months
measure: Change from 6 months visual acuity at 8 months
timeFrame: Change from 6 months to 8 months
measure: Change from 8 months visual acuity at 10 months
timeFrame: Change from 8 months to 10 months
measure: Change from 10 months visual acuity at 12 months
timeFrame: Change from 10 months to 12 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Ophthalmic Research Center
Study officials:
affiliation: Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences
name: Alireza Ramezani
role: PRINCIPAL_INVESTIGATOR
References: