Efficacy and Safety of Ranibizumab 0.5 mg for the Treatment of Macular Edema Resulting from Uncommon Causes: Twelve-Month Findings from PROMETHEUS.

Staurenghi, Giovanni; Lai, Timothy Y Y; Mitchell, Paul; Wolf, Sebastian; Wenzel, Andreas; Li, Jun; Bhaumik, Amitabha; Hykin, Philip G (2018). Efficacy and Safety of Ranibizumab 0.5 mg for the Treatment of Macular Edema Resulting from Uncommon Causes: Twelve-Month Findings from PROMETHEUS. Ophthalmology, 125(6), pp. 850-862. Elsevier 10.1016/j.ophtha.2017.12.002

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PURPOSE To evaluate the efficacy and safety of ranibizumab 0.5 mg in adult patients with macular edema (ME) resulting from any cause other than diabetes, retinal vein occlusion, or neovascular age-related macular degeneration. DESIGN A phase 3, 12-month, double-masked, randomized, sham-controlled, multicenter study. PARTICIPANTS One hundred seventy-eight eligible patients aged ≥18 years. METHODS Patients were randomized 2:1 to receive either ranibizumab 0.5 mg (n = 118) or sham (n = 60) at baseline and month 1. From month 2, patients in both arms received open-label individualized ranibizumab treatment based on disease activity. A preplanned subgroup analysis was conducted on the primary end point on 5 predefined baseline ME etiologies (inflammatory/post-uveitis, pseudophakic or aphakic, central serous chorioretinopathy, idiopathic, and miscellaneous). MAIN OUTCOME MEASURES Changes in best-corrected visual acuity (BCVA; Early Treatment Diabetic Retinopathy Study letters) from baseline to month 2 (primary end point) and month 12 and safety over 12 months. RESULTS Overall, 156 patients (87.6%) completed the study. The baseline characteristics were well balanced between the treatment arms. Overall, ranibizumab showed superior efficacy versus sham from baseline to month 2 (least squares mean BCVA, +5.7 letters vs. +2.9 letters; 1-sided P = 0.0111), that is, a treatment effect (TE) of +2.8 letters. The mean BCVA gain from baseline to month 12 was 9.6 letters with ranibizumab. The TE at month 2 was variable in the 5 predefined etiology subgroups, ranging from >5-letter gain to 0.5-letter loss. The safety findings were consistent with the well-established safety profile of ranibizumab. CONCLUSIONS The primary end point was met and ranibizumab showed superiority in BCVA gain over sham in treating ME due to uncommon causes, with a TE of +2.8 letters versus sham at month 2. At month 12, the mean BCVA gain was high (9.6 letters) in the ranibizumab arm; however, the TE was observed to be variable across the different etiology subgroups, reaching a >1-line TE in BCVA in patients with ME resulting from inflammatory conditions/post-uveitis or after cataract surgery. Overall, ranibizumab was well tolerated with no new safety findings up to month 12.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Head Organs and Neurology (DKNS) > Clinic of Ophthalmology

UniBE Contributor:

Wolf, Sebastian

Subjects:

600 Technology > 610 Medicine & health

ISSN:

0161-6420

Publisher:

Elsevier

Language:

English

Submitter:

Sebastian Wolf

Date Deposited:

27 Feb 2018 13:22

Last Modified:

24 May 2018 01:31

Publisher DOI:

10.1016/j.ophtha.2017.12.002

PubMed ID:

29371007

BORIS DOI:

10.7892/boris.110413

URI:

https://boris.unibe.ch/id/eprint/110413

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