Main finding: Ranibizumab monotherapy and combined with laser provided superior visual acuity gain over standard laser in patients with DME.
Purpose: To demonstrate superiority of ranibizumab 0.5 mg monotherapy or combined with laser over laser alone in BCVA over 12 months in diabetic macular edema
Study type: Randomized controlled trial
Condition: Diabetic Macular Edema
Participants: Type 1 or 2 DM, DME, BCVA 20/32–20/160
n=345
Intervention:
Group 1: Ranibizumab (with sham laser)
Group 2: Ranibizumab + laser
Group 3: Laser (with sham injections)
Outcomes
RAN
RAN + laser
Laser
Mean BCVA letter score change at 12 months
+6.1
+5.9
+0.8
Proportion with BCVA ≥ 20/40
53%
44.9%
23.6%
May 1, 2014
Clinical trial
Three-year outcomes of individualized ranibizumab treatment in patients with diabetic macular edema: the RESTORE extension study.
Schmidt-Erfurth U, Lang GE, Holz FG, Schlingemann RO, Lanzetta P, Massin P, Gerstner O, Bouazza AS, Shen H, Osborne A, Mitchell P.
Main finding: Ranibizumab monotherapy and combined with laser provided superior visual acuity gain over standard laser in patients with DME.
Purpose: To demonstrate superiority of ranibizumab 0.5 mg monotherapy or combined with laser over laser alone in BCVA over 12 months in diabetic macular edema
Study type: Extension study of Randomized controlled trial
Condition: Diabetic Macular Edema
Participants: Type 1 or 2 DM, DME, BCVA 20/32–20/160
n=345
Intervention:
Group 1: Ranibizumab (with sham laser)
Group 2: Ranibizumab + laser
Group 3: Laser (with sham injections)
Ranibizumab was effective in improving and maintaining BCVA and CRST outcomes with a progressively declining number of injections.
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