COMMENTARY

Ranibizumab vs Laser in Diabetic Macular Edema

Kanish Mirchia, MBBS; Sophie J. Bakri, MD

Disclosures

August 06, 2014

Study Findings

At the end of the study, although not statistically significant (P = .083), the mean BCVA increased by 6 ETDRS letters in the ranibizumab arm and decreased by 0.9 letters in the laser treatment arm. The changes in OCT-measured central subfield thickness were also not statistically significant (P = .06) but did show a trend toward a greater reduction in the ranibizumab group (132 µm vs 103 µm). Functional endpoints are summarized in Table 1.

Table 1. Findings on Functional Endpoints

Endpoint Ranibizumab Laser
BCVA (ETDRS letters)
Baseline 70.4 (± 4.9) 63.8 (± 5.7)
48 weeks 76.4 (± 8.5) 62.8 (± 10.6)
Change (P = .083) 6 -0.9
Microperimetry 4° (dB)
Baseline 10.8 (± 3.7) 10.2 (± 3.8)
48 weeks 14.0 (± 4.2) 12.1 (± 3.4)
Change 3.2 1.9
Microperimetry 12° (dB)
Baseline 13.3 (± 2.7) 13.4 (± 2.5)
48 weeks 15.7 (± 2.8) 14.5 (± 2.0)
Change 2.4 1.1
Protan sensitivity (%)(a)
Baseline 21.4 (± 22.5) 22.9 (± 22.8)
48 weeks 18.0 (± 16.9) 31.0 (± 35.0)
Change +3.4% -8.1%
Tritan sensitivity (%)(a)
Baseline 80.7 (± 29.6) 88.9 (± 20.7)
48 weeks 69.9 (± 34.5) 85.8 (± 25.0)
Change +10.8% +3.1%
Pattern ERG (P50(b))
Change 0.04 μv (↑ 2.9%) -0.13 μv (↓ 10.5%)
Multifocal ERG
Central macular function ↑ in 34% patients ↑ in 18% patients
  ↓ in 14% patients ↓ in 27% patients

BCVA = best correct visual acuity; ERG = electroretinography; ETDRS = Early Treatment Diabetic Retinopathy Study. (a)A lower threshold value indicated higher sensitivity. (b)Positive component of waveform at 50 ms.

Subjective evaluation of fundus photographs, OCT scans, and fluorescein angiograms revealed that subretinal fluid was reduced in the ranibizumab-treated individuals but not in the laser-treated group. In addition, the ranibizumab group had a statistically significant (P = .01) lower prevalence of interruption in the external limiting membrane and a nonsignificant (P = 0.14) reduction in the prevalence of interrupted inner segment/outer segment junction. Arguably, these changes could also have been a result of better fundus visualization after treatment.

Structural and safety endpoints are summarized in Table 2.

Table 2. Findings on Structural and Safety Endpoints

Structural Endpoints Ranibizumab Laser P Value
OCT central subfield thickness (μm)
Baseline 455 (± 79) 488 (± 96)  
48 weeks 324 (± 78) 385 (± 98)  
Change ↓ 132 (± 98) ↓ 103 (± 88) .06
OCT total macular volume (mm3)
Baseline 10.53 (± 1.62) 10.47 (± 1.69)  
48 weeks 8.96 (± 0.81) 9.77 (± 1.15)  
Change ↓ 1.57 (± 0.98) ↓ 0.69 (± 0.82) .03
Diabetic retinopathy grade (n of patients)
Improved 2 grades 2    
Improved 1 grades 7 4  
No change 10 6  
Worsened 1 grade 2    
Worsened 3 grade 1    
Safety Endpoints Ranibizumab Laser P Value
Ocular AEs (n) 19 1  
Nonocular AEs (n) 44 17  
Deaths(a) (n) 1 1  
Foveal avascular zone (mm2)
Baseline 0.255 0.346  
48 weeks 0.321 0.432  
Change     .476
Perifoveal capillary loss
Change No difference in score between groups .65

AE = adverse events; OCT = optical coherence tomography. (a)Unrelated to drug.

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