Journal List > J Korean Ophthalmol Soc > v.57(10) > 1010428

Kim, Kim, Kwak, and Yu: Long-term Outcomes of Diabetic Macular Edema Following Initial Intravitreal Ranibizumab Injection Based on Morphologic Pattern

Abstract

Purpose

To evaluate the 3-year visual and morphological outcomes of diabetic macular edema (DME) based on the morphological pattern observed on optical coherence tomography (OCT) after intravitreal ranibizumab injections.

Methods

Thirty-two eyes of 32 patients with DME were classified according to the following OCT features: diffuse retinal thickening (DRT), cystoid macular edema (CME), and serous retinal detachment (SRD). All patients received 3 consecutive monthly intravitreal injections of 0.5 mg ranibizumab. After 3 injections, patients received ranibizumab or dexamethasone implantation as needed. The primary outcome was the number of treatments received based on the DME type over 36 months. Best-corrected visual acuity (BCVA), central subfoveal thickness, and macular volume changes were also evaluated.

Results

The eyes were classified as DRT (n = 16), CME (6), or SRD (10). The mean number of injections over 3 years was significantly different among the groups: DRT (4.25), CME (7.5), SRD (7.6; p = 0.048). The number of patients who did not need additional treatment after the initial 3 injections was 13 with DRT (81.3%), 2 with CME (33.3%), and 5 with SRD (50%; p = 0.045). BCVA at 36 months significantly improved from baseline in the DRT group (p = 0.003). The CME group showed the worst BCVA among the groups (p = 0.023). Six patients who received intravitreal dexamethasone implantation showed no significant improvement of BCVA but significant decrease in macular volume from 12 to 36 months.

Conclusions

Clinical courses varied according to the morphological pattern of DME after intravitreal ranibizumab injection, and patients with DRT maintained visual and anatomical improvement with fewer injections over 36 months. Additional dexamethasone implantation showed limited effect in reducing macular edema with persistent macular cystic change, but no significant improvement in visual acuity.

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Figure 1.
Morphologic patterns of diabetic macular edema by optical coherence tomography. (A) Diffuse retinal thickening type looks as a sponge-like swelling area with reduced retinal reflectivity. (B) Cystoid macular edema type shows intraretinal cystoid spaces. (C) Serous retinal detachment exhibits elevation of retina and fluid is accumulated between retina and retinal pigment epithelium.
jkos-57-1604f1.tif
Figure 2.
Change in the mean best-corrected visual acuity (BCVA) over time after intravitreal Ranibizumab injection. In diffuse retinal thickening (DRT) type, significant improvement of BCVA was maintained from 3 to 36 months. In cystoid macular edema (CME) type, BCVA significantly improved over 12 months, but there was no significant difference with baseline from 18 to 36 months. serous retinal detachment (SRD) type showed significant BCVA improvement at 3 and 18months, which were not maintained over 36 months. SRD type showed poorer BCVA at 6, 12 months, and CME type showed poorer BCVA from 18 to 36 months than the other types. Error bar indicates 95% confidence interval.
jkos-57-1604f2.tif
Figure 3.
Change in the mean central subfoveal thickness (CST) over time after intravitreal Ranibizumab injection. In diffuse retinal thickening (DRT) and serous retinal detachment (SRD) types, CST significantly improved from the baseline through 36 months, except 18 months of SRD type. In cystoid macular edema (CME) type, significant improvement of CST was not maintained after 6 months. There was no difference in the CST between the individual types. Error bar indicates 95% confidence interval.
jkos-57-1604f3.tif
Figure 4.
Change in the mean macular volume over time after intravitreal Ranibizumab injection. In diffuse retinal thickening (DRT) type, macular volume significantly improved from the baseline until 18 months. In cystoid macular edema (CME) and serous retinal detachment (SRD) types, macular volume significantly deceased at 3 months after treatment, then aggravated until 18 months. However both types showed significant reduction of macular volume at 36 months compared to baseline. Error bar indicates 95% confidence interval.
jkos-57-1604f4.tif
Figure 5.
Change in the mean best-corrected visual acuity (BCVA), central subfoveal thickness (CST), and macular volume over time in Dexamethasone implantation added patients. (A) Mean BCVA was aggravated at 36 months (0.6) compared to 12 months, which was not significant (0.48) (p = 0.322). (B) Mean CST did not showed significant difference between 12 and 36 months (p = 0.833). (C) Mean macular volume significantly decreased from 12 months (12.1 mm3) to 36 months (11.38 mm3) (p = 0.001). Error bar indicates 95% confidence interval.
jkos-57-1604f5.tif
Table 1.
Baseline characteristics of eyes and optical coherence tomography findings
  DRT CME SRD p-value
Eyes (n, %) 16 (50) 6 (18.8) 10 (31.2)  
Mean Age (years) 59.81 ±11.02 61.17 ± 8.38 61.30 ± 10.94 0.979*
Mean HbA1C (%) 7.86 ± 1.59 8.10 ± 1.66 8.67 ± 1.60 0.353*
Diabetic retinopathy severity (n, %)        
   PDR 5 (31.3) 2 (33.3) 3 (30) 1.000
   NPDR 11 (68.7) 4 (66.7) 7 (70)  
Insulin treatment (n, %) 7 (43.8) 2 (33.3) 7 (70) 0.370
Mean time since diagnosis of diabetes (years) 15.00 ± 6.90 12.17 ± 4.62 13.40 ± 5.21 0.581*
Mean time since diagnosis of DME (years) 1.30 ± 1.11 1.92 ± 1.85 1.91 ± 1.08 0.431*
Mean BCVA (log MAR) 0.52 ± 0.16 0.64 ± 0.29 0.60 ± 0.23 0.062*
Mean CST (μ m) 338.44 ± 49.20 365.67 ± 126.2 380.6 ± 96.81 0.277*
Mean macular volume (mm3) 10.84 ± 0.90 11.72 ± 1.15 12.43 ± 2.09 0.058*

Values are presented as mean ± SD or n (%) unless otherwise indicated.

DRT = diffuse retinal thickening; CME = cystoid macular edema; SRD = serous retinal detachment; PDR = proliferative diabetic retinopathy; NPDR = nonproliferative diabetic retinopathy; DME = diabetic macular edema; BCVA = best-corrected visual acuity; log MAR = logarithm of the minimum angle of resolution; CST = central subfoveal thickness.

* Kruskal– Wallis test, statistical significance at 5% level

Fisher exact test, statistical significance at 5% level.

Table 2.
Mean number of intravitreal treatments received over 3 years
  DRT CME SRD p-value
Mean number of Ranibizumab treatments (n) 4.68 ± 0.95 7.50 ± 2.88 7.60 ± 3.98 0.048*
   (Day 1– Month 36)        
Mean number of Ranibizumab treatments (n) 3.50 ± 0.73 5.16 ± 1.94 4.90 ± 2.28 0.074*
   (Day 1– Month 12)        
Mean number of Ranibizumab treatments (n) 1.19 ± 0.73 2.33 ± 0.49 2.70 ± 0.68 0.037*
   (Month 12– Month 36)        
Eyes, no additional injections (n) 13 (81.3%) 2 (33.3%) 5 (50%) 0.045
   (Month 12– Month 36)        
Eyes, received Dexamethasone implantation (n) 1 (5.95%) 2 (33.3%) 3 (30%) 0.222
   (Month 12– Month 36)        
Mean number of Dexamethasone implantation (n) 1 1.5 1.67  
   (Month 12– Month 36)        

Values are presented as mean ± SD or n (%) unless otherwise indicated.

DRT = diffuse retinal thickening; CME = cystoid macular edema; SRD = serous retinal detachment.

* Kruskal– Wallis test, statistical significance at 5% level

Fisher exact test, statistical significance at 5% level.

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