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Ranibizumab monotherapy or combined with laser versus laser monotherapy for diabetic macular edema (RESTORE)

The RESTORE study: ranibizumab monotherapy or combined with laser versus laser monotherapy for diabetic macular edema.

Mitchell P, Bandello F, Schmidt-Erfurth U, Lang GE, Massin P, Schlingemann RO, Sutter F, Simader C, Burian G, Gerstner O, Weichselberger A.

Ophthalmology. 2011 Apr;118(4):615-25
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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

Intervention:

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%

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.

Ophthalmology. 2014 May;121(5):1045-53.
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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:

Ranibizumab was effective in improving and maintaining BCVA and CRST outcomes with a progressively declining number of injections.

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