Epiretinal Membrane in Patients With DR.

Epiretinal Membrane in Patients With Diabetic Retinopathy.

To report the prevalence of ERM among patients with diabetic retinopathy, and the possible associated risk factors.

Study Overview

• Status: Not yet recruiting
• Conditions: Epiretinal Membrane
• Intervention / Treatment: Radiation: OCT

Detailed Description

Epiretinal membrane (ERM) can be defined as pre-retinal proliferation of myofibroblastic cells associated with extracellular matrix (ECM). Various aetiologies can lead to this final common pathway. Current imaging modalities are excellent at identifying and grading severity of ERMs, but do not yet differentiate histopathological variations which suggest that this is a heterogeneous group of diseases.

The prevalence of epiretinal membrane (ERM) is 7% to 11.8%, with increasing age being the most important risk factor. Although most ERM is idiopathic, common secondary causes include cataract surgery, retinal vascular disease, uveitis and retinal tears. Anti-VEGF injections are identified as a significant risk factor for ERM formation especially in patients with diabetes. The myofibroblastic pre-retinal cells are thought to transdifferentiate from glial and retinal pigment epithelial cells that reach the retinal surface via defects in the internal limiting membrane (ILM) or from the vitreous cavity. Grading schemes have evolved from clinical signs to ocular coherence tomography (OCT) based classification with associated features such as the cotton ball sign. Features predictive of better prognosis include absence of ectopic inner foveal layers, cystoid macular oedema, acquired vitelliform lesions and ellipsoid and cone outer segment termination defects. OCT-angiography shows reduced size of the foveal avascular zone.

The presence of continuous ectopic inner foveal layers was significantly associated with lower visual acuity. ERMs are divided into 4 stages. Stage 1 ERMs are mild and thin and a foveal depression was present. Stage 2 ERMs are associated with widening of the outer nuclear layer and loss of the foveal depression.

Stage 3 ERMs are associated with continuous ectopic inner foveal layers crossing the entire foveal area. In stages 1, 2, and 3 all retinal layers were clearly defined on OCT. Stage 4 ERMs are thick and associated with continuous ectopic inner foveal layers. In addition, retinal layers were disrupted.

Vitrectomy with membrane peeling remains the mainstay of treatment for symptomatic ERMs. Additional ILM peeling reduces recurrence but is associated with anatomical changes including inner retinal dimpling.

• Study Type: Observational
• Enrollment (Estimated): 225

Contacts and Locations

• Study Contact: Name: merna maged, resident doctor; Phone Number: +201284143158; Email: mernamaged1@gmail.com
• Study Contact Backup: Name: salma kedwany, MD; Phone Number: +201062330885; Email: salmakedwany@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

diabetic patients above 18 years of age.

Description

Inclusion Criteria:

• Patients aged 18 years or older.
• Patients with ERM confirmed by OCT images.
• Patients with DM with varying severity of diabetic retinopathy.

Exclusion Criteria:

• • History of previous eye trauma or surgery other than uneventful cataract surgery, uveitis, history of retinal detachment, media opacity impairing the quality OCT images, high myopia, macular or retinal diseases disease affecting the visual acuity other than diabetic retinopathy, e.g. macular hole, retinitis pigmentosa, AMD, CRVO.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
frequency of ERM among patients presented with diabetic retinopathy	one year

Secondary Outcome Measures

Outcome Measure	Time Frame
detection of possible associated risk factors including age, gender, type and duration and control of diabetes, hypertension, IHD, diabetic nephropathy, severity of diabetic retinopathy.	two years

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Bu SC, Kuijer R, Li XR, Hooymans JM, Los LI. Idiopathic epiretinal membrane. Retina. 2014 Dec;34(12):2317-35. doi: 10.1097/IAE.0000000000000349.
• Kakihara S, AbdelSalam M, Zhuang K, Fawzi AA. Epiretinal Membrane Is Associated with Diabetic Retinopathy Severity and Cumulative Anti-VEGF Injections. Ophthalmol Sci. 2025 Feb 7;5(3):100733. doi: 10.1016/j.xops.2025.100733. eCollection 2025 May-Jun.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 21, 2025

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: oct
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Metabolic Diseases; Eye Diseases; Genetic Diseases, X-Linked; Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Amino Acid Metabolism, Inborn Errors; Retinal Diseases; Urea Cycle Disorders, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nutritional and Metabolic Diseases; Ornithine Carbamoyltransferase Deficiency Disease; Epiretinal Membrane
• Other Study ID Numbers: epiretinal membrane in OCT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No