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Clinical Trials in Egypt / NCT06841250
Enrolling by invitation Observational

Early Changes in OCT Biomarkers After the First Intravitreal Anti-VEGF Injection in Treatment-naïve DME

NCT06841250 · tracked via the Priya Life Science Egypt tracker
Sponsor
Sohag University
Phase
Observational
Started
2025-01-16
Last updated
2025-02-24

Condition(s) studied

Early OCT Biomarker Changes in Response to Anti-VEGF

Investigational drug(s) / intervention(s)

intravitreal injection of anti-VEGF

intravitreal injection of anti-VEGF: Ranibizumab is injected into the vitreous under aseptic conditions as part of routine DME treatment

Study summary

A retrospective, observational, hospital-based study which will be conducted in the Department of Ophthalmology, Sohag University Hospital, Egypt.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Diabetic patients with centre-involving DME (CI-DME) who are treatment-naïve. * Central macular thickness (CMT) of 300 microns or more will be accepted as DME. Exclusion Criteria: * Media opacities affecting OCT imaging (corneal pathologies, dense cataracts, vitreous opacities, etc). * Patients with any other retinal vascular diseases (retinal vein occlusion, central serrous chorioretinopathy, age-related macular degeneration, etc). * Patients who have had previous intravitreal injections or Laser treatment. * Patients who underwent previous vitreoretinal surgeries. * Patients with recent history of undergoing cataract surgery. * Patients with uncontrolled glaucoma or ocular inflammations (eg: vitritis).

Primary outcome measure(s)

  • Visual acuity — one month
    Visual acuity assessment pre and post injection will be recorded
  • Central subfield thickness — one month
    Central subfield thickness assessment pre and post injection will be recorded
  • Intraretinal cystoid spaces — one month
    Intraretinal cystoid space location, size and bridging will be recorded pre and post injection
  • Subfoveal neuroretinal detatchment — one month
    Presence and extent of Subfoveal neuroretinal detatchment assessed pre and post injection will be recorded
  • Hyperreflective foci — one month
    number and locatio of Hyperreflective foci assessed pre and post injection will be recorded
  • Outer retinal layer integrity — one month
    Outer retinal layer integrity assessment pre and post injection will be recorded
  • Disorganised inner retinal layers — one month
    Disorganised inner retinal layers assessment pre and post injection will be recorded

Trial sites (1)

FacilityCityRegionStatus
Sohag University Sohag Egypt

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06841250 on ClinicalTrials.gov ↗ ← All trials in Egypt