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Ophthalmology. 2013 Jan;120(1):130-9. doi: 10.1016/j.ophtha.2012.07.026. Epub 2012 Sep 25.

The SECURE study: long-term safety of ranibizumab 0.5 mg in neovascular age-related macular degeneration.

Author information

1
Department of Ophthalmology, Coimbra University Hospital, Faculty of Medicine, University of Coimbra, and Association for Innovation and Biomedical Research on Light and Image (AIBILI), Coimbra, Portugal. rufino.silva@oftalmologia.co.pt

Abstract

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00504959.

PMID:
23021093
DOI:
10.1016/j.ophtha.2012.07.026
[Indexed for MEDLINE]

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