Treatment of Diabetic Macular Edema with Intravitreal Antivascular Endothelial Growth Factor and Prompt versus Deferred Focal Laser during Long-Term Follow-Up and Identification of Prognostic Retinal Markers

Abstract

Purpose Long-term follow-up of patients with diabetic macular edema (DME) treated with intravitreal antivascular endothelial growth factor (anti-VEGF) combined focal laser and identification of prognostic morphological characteristics. Methods Prospective clinical trial (50 treatment-naive eyes) with DME randomized 1 : 1 receiving intravitreal ranibizumab (0.5 mg/0.05 ml) and prompt grid laser compared with ranibizumab and deferred laser. Morphological characteristics potentially relevant for prognosis were assessed at baseline, month 6, month 9, and years 1, 2, 3, 4, and 5 of follow-up. Results Although functional results were slightly higher in the prompt group at week 12 (0.5; 20/40 Snellen (SD = 0.04, 0.3 logMAR) versus 0.4; 20/50 Snellen (SD = 0.04, logMAR: 0.4), p=0.4) and month 9 (prompt group: 0.5; 20/40 Snellen (SD = 0.03, 0.3 logMAR) versus deferred group: 0.4; 20/50 Snellen (SD = 0.04, 0.4 logMAR), p=0.4), these were statistically insignificant. There was no significant benefit regarding functionality during long-term follow-up in the prompt group compared to the deferred group. BCVA in the eyes with clusters of hyperreflective foci in the central macular region was inferior compared with the eyes without these alterations at year 5 (0.39; 20/50 Snellen, (SD = 0.25, 0.4 logMAR) versus 0.63; 20/80 Snellen (SD = 0.22, 0.2 logMAR), p < 0.01). Conclusion Grid laser and ranibizumab therapy are effective in DME management during the long-term follow-up. Intraretinal hyperreflective material in SD-OCT is negatively related to BCVA.

Response of OCT Biomarkers Based on New Diabetic Macular Edema Classification TCED-HFV to Anti-VEGF Therapy and Its Prognostic Role in Vision Benefits

“…In our study, a signi cantly decreased HF could be found under adequate anti-VEGF treatment. This result is consistent with the results observed in previous studies that hyperre ective foci or spots decreased after anti-VEGF treatment [18,14,10]. The exact formation mechanism of HF remains still unclear despite several theories have attempt to explain the special marker.…”

“…Similar progress has been made in patients with DME because OCT has been able to identify various pathologies in these patients, such as CMT, HF, SF, EZ/ELM irregularity and DRIL, and these ndings have begun to clarify the pathogenesis and prognosis of the disease. A large number of studies have been conducted on DME patients receiving anti-VEGF injections, and it has been con rmed that the microstructural changes seen at the baseline by OCT scans can predict the treatment response [14,10,15]. The TCED-HFV classi cation, as a non-invasive diagnostic method, had shown its potential for early diagnosis of DME and could quantitatively response the therapeutic effect to anti-VEGF treatment.…”

Significance of Hyperreflective Foci as an Optical Coherence Tomography Biomarker in Retinal Diseases: Characterization and Clinical Implications

“…DME with HRF has been associated with a poorer visual outcome following treatment with intravitreal steroid and anti-VEGF agents [14]. Clusters of HRF occupying the central macular area was associated with worse visual acuity than eyes without HRF clusters before any treatment, and the functional difference was maintained following intravitreal ranibizumab and focal laser therapy for up to 5 years [50].…”

Diabetic Macular Edema in Diabetological Practices

“…Wichtige Parameter sind der Visus, die Dicke der Netzhaut im Makulabereich, die Fläche des diabetischen Makulaödems und der klinische Verlauf. In der Regel besteht dann ein "klinisch relevantes diabetisches Makulaödem mit Notwendigkeit einer Therapie", wenn mit einer Fluoreszenzangiografie oder mittels SD-OCT (Spectral-Domain-OCT) ein diffuses Makulaödem mit zentraler Netzhautdicke (CRT) ≥ 300 μm im Zentrum der Makula nachgewiesen wurde und ein Visus schlechter 0,8 besteht [5]. In der VISTA-Studie war die Indikation für eine intravitreale Anti-VEGF-Injektion eine Verdickung der Netzhaut innerhalb des zentralen 1-mm-Teilfeldes und ein Visus schlechter 0,5.…”