Micropulse laser treatment for new and refractory center-involved diabetic macular edema
Official title: Comparative Evaluation of Micropulse Laser in Treatment of Initial and Refractory Cases of Center-Involved Diabetic Macular Edema
Run by The General Authority for Teaching Hospitals and Institutes · NCT07295704 · Data updated 2026-11-12
This project will test whether a subthreshold 577 nm micropulse laser helps adults with new or treatment-resistant center-involved diabetic macular edema reduce retinal swelling and improve vision.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | The General Authority for Teaching Hospitals and Institutes Research network |
| Locations | 1 site (Cairo) |
| Status | Recruiting |
| Started | October 15, 2025 |
| Main results expected | March 30, 2026 |
| Study ends | March 30, 2026 |
| Registry record updated | December 22, 2025 |
| Trial ID | NCT07295704 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with type 1 or 2 diabetes, center-involved DME (CMT >250 and <700 µm) and BCVA ≥20/400, without active high-risk proliferative disease or recent ocular surgery, are ideal candidates.
✕Probably not a fit
Patients with vitreomacular traction, epiretinal membrane, monocular eyes, high-risk proliferative diabetic retinopathy, severe glaucoma, recent intraocular surgery, or very poor systemic control (HbA1c >10%) are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational protocol follows adults with center-involved diabetic macular edema who receive subthreshold 577 nm micropulse laser photocoagulation, comparing outcomes in initial versus refractory cases. Treatment uses short duty-cycle pulses to deliver energy below the visible thermal endpoint, aiming to limit tissue heating while stimulating retinal repair. Key outcomes include changes in central macular thickness measured by spectral-domain OCT and best-corrected visual acuity over scheduled follow-up visits. Eligible patients have CMT between 250 and 700 µm and BCVA of 20/400 or better, with exclusions for tractional causes or recent intraocular surgery.
Why it matters
Potential benefit: If successful, the approach could reduce macular swelling and improve or stabilize vision with less retinal thermal damage than conventional laser.
How similar studies have gone: Previous studies of subthreshold micropulse laser for DME have reported modest reductions in retinal thickness and occasional vision gains, though results have been mixed and evidence is less robust for refractory cases.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years. * Both sexes. * Patients with type 1 or 2 diabetes mellitus (DM), best-corrected visual acuity (BCVA) of 20/400 or better, and center-involved DME \[defined as a central macular thickness (CMT) of \>250 but \<700µm measured by spectral-domain optical coherence tomography\]. * Patients with any level of non-proliferative diabetic retinopathy or proliferative diabetic retinopathy with adequate panretinal photocoagulation (PRP) and no signs of disease activity determined by fluorescein angiography (FA). Exclusion Criteria: * Monocular eyes. * Chronic renal failure or renal transplant because of diabetic nephropathy. * Glycated hemoglobin (HbA1c) of more than 10%. * Vitreomacular traction syndrome. * Epiretinal membrane. * PRP within 4months before the treatment. * Intraocular surgery within 6months, including cataract or vitreoretinal operation. * Rubeosis iridis. * Severe glaucoma. * High-risk proliferative diabetic retinopathy. * Poor dilation. * Increased foveal avascular zone. * Any condition that could interfere with optical coherence tomography (OCT) measurement or visual acuity.
Where it's running
-
the General Authority for Teaching Hospitals and Institutes
Cairo, Egypt Recruiting
Study contacts
- Study coordinator: Hossam A Hassan, MD
- Email: Dr.hossameabdalfataah@gothi.gov.eg
- Phone: 00201026808348
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.