Ribeiro Luisa, Bandello Francesco, Tejerina Amparo Navea, Vujosevic Stela, Varano Monica, Egan Catherine, Sivaprasad Sobha, Menon Geeta, Massin Pascale, Verbraak Frank D, Lund-Andersen Henrik, Martinez Jose P, Jürgens Ignasi, Smets Erica, Coriat Caroline, Wiedemann Peter, Ágoas Victor, Querques Giuseppe, Holz Frank G, Nunes Sandrina, Neves Catarina, Cunha-Vaz José
Association for Innovation and Biomedical Research on Light and Image (AIBILI) Coimbra, Portugal.
Department of Ophthalmology, University Vita Salute-Scientific Institute of San Raffael, Milan, Italy.
Invest Ophthalmol Vis Sci. 2015 Aug;56(9):5698-705. doi: 10.1167/iovs.15-16708.
To identify eyes of patients with diabetes type 2 that show progression of retinal disease within a 1-year period using noninvasive techniques.
Three hundred seventy-four type 2 diabetic patients with mild nonproliferative diabetic retinopathy (Early Treatment Diabetic Retinopathy Study [ETDRS] level 20 or 35) were included in a 12-month prospective observational study to identify retinopathy progression. Four visits were scheduled at 0, 3, 6, and 12 months. Microaneurysm (MA) activity using the RetmarkerDR and retinal thickness using spectral-domain optical coherence tomography (SD-OCT) were assessed by a central reading center at all visits and ETDRS severity level in the first and last visits.
Three hundred thirty-one eyes/patients completed the study. Microaneurysm formation rate greater than or equal to 2 was present in 68.1% of the eyes and MA turnover greater than or equal to 6 in 54.0% at month 6. Higher MA turnover values were registered in eyes that showed progression in ETDRS severity level (P < 0.03). There were also significant correlations between increased microaneurysm activity and increases in retinal thickness. Spectral-domain OCT identified clinical macular edema in 24 eyes/patients (6.7%) and subclinical macular edema in 104 eyes/patients (28.9%) at baseline. Progression of retinal thickening was registered in eyes that had either subclinical or clinical macular edema at baseline.
Changes in MA activity measured with RetmarkerDR and in central retinal thickness in eyes with mild nonproliferative diabetic retinopathy and diabetes type 2 are able to identify eyes at risk of progression. These eyes/patients should be selected for inclusion in future clinical trials of drugs targeted to prevent diabetic retinopathy progression to vision-threatening complications. (ClinicalTrials.gov number, NCT01145599.)
使用非侵入性技术识别2型糖尿病患者中在1年内出现视网膜疾病进展的眼睛。
374例患有轻度非增殖性糖尿病视网膜病变（早期治疗糖尿病视网膜病变研究[ETDRS] 20级或35级）的2型糖尿病患者纳入一项为期12个月的前瞻性观察研究，以确定视网膜病变进展情况。在0、3、6和12个月安排了4次就诊。所有就诊时均由中央阅片中心评估使用RetmarkerDR的微动脉瘤（MA）活性以及使用光谱域光学相干断层扫描（SD-OCT）的视网膜厚度，并在首次和末次就诊时评估ETDRS严重程度级别。
331只眼/患者完成了研究。6个月时，68.1%的眼睛微动脉瘤形成率大于或等于2，54.0%的眼睛MA周转率大于或等于6。ETDRS严重程度级别出现进展的眼睛中MA周转率值更高（P < 0.03）。微动脉瘤活性增加与视网膜厚度增加之间也存在显著相关性。光谱域OCT在基线时识别出24只眼/患者（6.7%）有临床黄斑水肿，104只眼/患者（28.9%）有亚临床黄斑水肿。基线时有亚临床或临床黄斑水肿的眼睛出现了视网膜增厚进展。
使用RetmarkerDR测量的MA活性变化以及患有轻度非增殖性糖尿病视网膜病变和2型糖尿病的眼睛的中央视网膜厚度变化能够识别有进展风险的眼睛。这些眼睛/患者应被选入未来旨在预防糖尿病视网膜病变进展为威胁视力并发症的药物临床试验。（ClinicalTrials.gov编号，NCT01145599。）
