The SECURE Study: Long-Term Safety of Ranibizumab 0.5 mg in Neovascular Age-related Macular Degeneration

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• 作者：Rufino Silva ; MD ; PhD¹ ; ^{rufino.silva@oftalmologia.co.pt} ; Ruth Axer-Siegel ; MD² ; Bora Eldem ; MD³ ; Robyn Guymer ; MD ; PhD⁴ ; Bernd Kirchhof ; MD⁵ ; Andras Papp ; MD ; PhD⁶ ; Andras Seres ; MD⁷ ; Margarita Gekkieva ; MD⁸ ; Annette Nieweg ; PhD⁸ ; Stefan Pilz ; PhD⁸ ; SECURE Study Group
• 刊名：Ophthalmology
• 出版年：2013
• 出版时间：January, 2013
• 年：2013
• 卷：120
• 期：1
• 页码：130-139
• 全文大小：1761 K

文摘

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Objective

To evaluate long-term safety of intravitreal ranibizumab 0.5-mg injections in neovascular age-related macular degeneration (nAMD).

Design

Twenty-four-month, open-label, multicenter, phase IV extension study.

Participants

Two hundred thirty-four patients previously treated with ranibizumab for 12 months in the EXCITE/SUSTAIN study.

Methods

Ranibizumab 0.5 mg administered at the investigator's discretion as per the European summary of product characteristics 2007 (SmPC, i.e., ranibizumab was administered if a patient experienced a best-corrected visual acuity [BCVA] loss of >5 Early Treatment Diabetic Retinopathy Study letters measured against the highest visual acuity [VA] value obtained in SECURE or previous studies [EXCITE and SUSTAIN], attributable to the presence or progression of active nAMD in the investigator's opinion).

Main Outcome Measures

Incidence of ocular or nonocular adverse events (AEs) and serious AEs, mean change in BCVA from baseline over time, and the number of injections.

Results

Of 234 enrolled patients, 210 (89.7 % ) completed the study. Patients received 6.1 (mean) ranibizumab injections over 24 months. Approximately 42 % of patients had 7 or more visits at which ranibizumab was not administered, although they had experienced a VA loss of more than 5 letters, indicating either an undertreatment or that factors other than VA loss were considered for retreatment decision by the investigator. The most frequent ocular AEs (study eye) were retinal hemorrhage (12.8 % ; 1 event related to study drug), cataract (11.5 % ; 1 event related to treatment procedure), and increased intraocular pressure (6.4 % ; 1 event related to study drug). Cataract reported as serious due to hospitalization for cataract surgery occurred in 2.6 % of patients; none was suspected to be related to study drug or procedure. Main nonocular AEs were hypertension and nasopharyngitis (9.0 % each). Arterial thromboembolic events were reported in 5.6 % of the patients. Five (2.1 % ) deaths occurred during the study, none related to the study drug or procedure. At month 24, mean BCVA declined by 4.3 letters from the SECURE baseline.

Conclusions

The SECURE study showed that ranibizumab administered as per a VA-guided flexible dosing regimen recommended in the European ranibizumab SmPC at the investigator's discretion was well tolerated over 2 years. No new safety signals were identified in patients who received ranibizumab for a total of 3 years. On average, patients lost BCVA from the SECURE study baseline, which may be the result of disease progression or possible undertreatment.

Financial Disclosure(s)

Proprietary or commercial disclosure may be found after the references.