Primary End Point (Six Months) Results of the Ranibizumab for Edema of the mAcula in diabetes (READ-2) study.
OBJECTIVE
To compare ranibizumab with focal/grid laser or a combination of both in diabetic macular edema (DME).


METHODS
Prospective, randomized, interventional, multicenter clinical trial.


METHODS
A total of 126 patients with DME.


METHODS
Subjects were randomized 1:1:1 to receive 0.5 mg of ranibizumab at baseline and months 1, 3, and 5 (group 1, 42 patients), focal/grid laser photocoagulation at baseline and month 3 if needed (group 2, 42 patients), or a combination of 0.5 mg of ranibizumab and focal/grid laser at baseline and month 3 (group 3, 42 patients).


METHODS
The primary end point was the change from baseline in best-corrected visual acuity (BCVA) at month 6.


RESULTS
At month 6, the mean gain in BCVA was significantly greater in group 1 (+7.24 letters, P = 0.01, analysis of variance) compared with group 2 (-0.43 letters), and group 3 (+3.80 letters) was not statistically different from groups 1 or 2. For patients with data available at 6 months, improvement of 3 lines or more occurred in 8 of 37 (22%) in group 1 compared with 0 of 38 (0%) in group 2 (P = 0.002, Fisher exact test) and 3 of 40 (8%) in group 3. Excess foveal thickness was reduced by 50%, 33%, and 45% in groups 1, 2, and 3, respectively.


CONCLUSIONS
During a span of 6 months, ranibizumab injections by the current protocol had a significantly better visual outcome than focal/grid laser treatment in patients with DME.
Nguyen
Quan Dong
QD
Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland 21287-9277, USA.
Shah
Syed Mahmood
SM
Heier
Jeffery S
JS
Do
Diana V
DV
Lim
Jennifer
J
Boyer
David
D
Abraham
Prema
P
Campochiaro
Peter A
PA
D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D061067:Antibodies, Monoclonal, Humanized; D003131:Combined Modality Therapy; D003930:Diabetic Retinopathy / Q000188:drug therapy / Q000503:physiopathology / Q000601:surgery / Q000628:therapy*; D023381:Endpoint Determination; D005260:Female; D006801:Humans; D007267:Injections; D017075:Laser Coagulation; D008269:Macular Edema / Q000188:drug therapy / Q000503:physiopathology / Q000601:surgery / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D000069579:Ranibizumab; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology; D014822:Vitreous Body
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000069579:Ranibizumab