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. 2025 Apr 18;17(4):e82520.
doi: 10.7759/cureus.82520. eCollection 2025 Apr.

A Study of Visual Outcomes and Spectral Domain Optical Coherence Tomography (SD-OCT) Biomarker Changes in Patients Treated With Ranibizumab for Diabetic Macular Edema in a Tertiary Hospital

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A Study of Visual Outcomes and Spectral Domain Optical Coherence Tomography (SD-OCT) Biomarker Changes in Patients Treated With Ranibizumab for Diabetic Macular Edema in a Tertiary Hospital

Rashmitha Somagani et al. Cureus. .

Abstract

Introduction: Diabetic macular edema (DME) is a leading cause of vision impairment in diabetes mellitus. Spectral-domain optical coherence tomography (SD-OCT) provides valuable biomarkers for assessing disease severity and treatment response. This study evaluates the visual outcomes and SD-OCT biomarker changes in patients treated with intravitreal ranibizumab at a tertiary hospital.

Materials and methods: A prospective cohort study was conducted on 50 Type 2 diabetes mellitus patients with center-involving DME at Employees' State Insurance Corporation (ESIC) Medical College and Hospital, Hyderabad, from July 2022 to December 2023. Inclusion criteria were best-corrected visual acuity (BCVA) <6/9 and central retinal thickness (CRT) ≥280 µm. Exclusion criteria included other retinal diseases, vision-impairing cataracts, or glaucoma. Patients received three monthly intravitreal ranibizumab injections and were followed up at one, two, three, and six months. BCVA, CRT, and SD-OCT biomarkers such as hyperreflective foci (HRF), subretinal neuroretinal detachment (SND), intraretinal cyst (IRC) size, disorganization of retinal inner layers (DRIL), ellipsoid zone (EZ) disruption, and external limiting membrane (ELM) disruption were assessed. Statistical analysis was performed using SPSS software, version 26 (IBM Corp., Armonk, NY).

Results: BCVA improved from 0.76±0.39 at baseline to 0.37±0.29 at six months (p<0.00001). CRT reduced from 473.66±111.65 µm to 326.64±71.37 µm (p<0.00001). HRF, SND, and IRC size showed significant regression. DRIL, EZ, and ELM disruption improved significantly (p<0.00001). There was no statistically significant association between OCT biomarker features and BCVA improvement of more than three lines.

Conclusion: Intravitreal ranibizumab significantly improves visual acuity and reduces retinal thickness in DME patients. SD-OCT biomarkers are valuable in monitoring treatment response and disease progression.

Keywords: diabetic macular edema; ranibizumab; retinal biomarkers; spectral-domain oct; visual acuity.

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Conflict of interest statement

Human subjects: Consent for treatment and open access publication was obtained or waived by all participants in this study. Institutional Ethics Committee, Employee's State Insurance Corporation (ESIC) Medical College and Hospital, Hyderabad issued approval 799/U/IEC/ESICMC/S0167/07/2022. Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work.

Figures

Figure 1
Figure 1. Consort flow diagram

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