UnknownPhase 2/3

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

Iran30 participantsStarted 2022-10-15

Plain-language 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.

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from baseline central macular thickness at 2 months

Timeframe: Change from baseline to 2 months

Change from 2 months central macular thickness at 3 months

Timeframe: Change from 2 months to 3 months

Change from 3 months central macular thickness at 4 months

Timeframe: Change from 3 months to 4 months

Change from 4 months central macular thickness at 6 months

Timeframe: Change from 4 months to 6 months

Change from 6 months central macular thickness at 8 months

Timeframe: Change from 6 months to 8 months

Change from 8 months central macular thickness at 10 months

Timeframe: Change from 8 months to 10 months

Change from 10 months central macular thickness at 12 months

Timeframe: Change from 10 months to 12 months

Trial details

NCT IDNCT05582577

SponsorShahid Beheshti University of Medical Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-15

View on ClinicalTrials.gov More Diabetic Macular Edema trials