Epiretinal Membrane in Patients With DR.

NCT ID: NCT07241845

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 225 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2028-10-31

Brief Summary

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

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.

Conditions

Epiretinal Membrane

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Interventions

OCT

All the patients will undergo OCT imaging using NIDEK RS-330 Retina scan duo 2 (SD-OCT)(CO-LTD made in Japan 2017) with scan speed 70.000 axial scans per second and wavelength of 880 nm. A three-dimensional scan protocol will be used for macular measurements. Macular scans will be performed with axial scanning protocols covering a 9 × 9 mm area centered on the fovea.

OCT images will be evaluated by a trained ophthalmologist for the following:

• Stage of ERM will be classified by Govetto et al system into stage 1,2,3 or 4.

Stage 1: ERMs were mild and thin. Foveal depression is present. Stage 2: ERMs with a widening of the outer nuclear layer and loss of the foveal depression.

Stage 3: ERMs with continuous ectopic inner foveal layers crossing the entire foveal area.

Stage 4: ERMs were thick with continuous ectopic inner foveal layers and disrupted retinal layers.

• central macular thickness CMT

Intervention Type: RADIATION

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Merna Maged Monir Aziz

resident doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

merna maged, resident doctor

Role: CONTACT

mernamaged1@gmail.com

+201284143158

salma kedwany, MD

Role: CONTACT

salmakedwany@aun.edu.eg

+201062330885

References

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.

Reference Type: BACKGROUND

PMID: 40161463 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25360790 (View on PubMed)

Other Identifiers

epiretinal membrane in OCT

Identifier Type: -

Identifier Source: org_study_id