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Cited by 356Retinal Diseases and TreatmentsRetinal and Macular SurgeryOcular Diseases and Behçet’s Syndrome

The DOI matches its Crossref record; 14 of the 14 references it cites were found in a registry or an index.

HORIZON: An Open-Label Extension Trial of Ranibizumab for Choroidal Neovascularization Secondary to Age-Related Macular Degeneration

Singer, Michael A., Awh, Carl C., Sadda, SriniVas, Freeman, William R., Antoszyk, Andrew N., Wong, Pamela, Tuomi, Lisa·2012·Ophthalmology
DOI 10.1016/j.ophtha.2011.12.016
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Abstract

Objective To evaluate the long-term safety and efficacy of multiple intravitreal ranibizumab injections (Lucentis, Genentech, Inc., South San Francisco, CA) administered at the investigator's discretion in patients with choroidal neovascularization secondary to age-related macular degeneration.Design An open-label, multicenter, extension study.Participants Patients who completed the controlled treatment phase of 1 of 3 prospective, randomized, 2-year clinical trials of ranibizumab were eligible for enrollment. Analyses were performed for 3 groups: (1) patients treated with ranibizumab in the initial study (ranibizumab treated-initial; n = 600); (2) patients randomized to control who crossed over to receive ranibizumab (ranibizumab treated-XO; n = 190); and (3) ranibizumab-naïve patients (ranibizumab untreated; n = 63).Methods Ranibizumab 0.5 mg was administered at the investigator's discretion. Adverse events (AEs) and Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) assessments were conducted at study visits every 3 to 6 months.Main outcome measures Incidence and severity of AEs.Results There was 1 occurrence of mild endophthalmitis per 3552 HORIZON injections in the ranibizumab treated-initial/ranibizumab treated-XO groups. There were no serious AE reports of lens damage, retinal tears, or rhegmatogenous retinal detachments in the study eyes. The proportion of patients with any single postdose intraocular pressure ≥30 mmHg was 9.2%, 6.6%, and 0%, and the proportion of patients with glaucoma was 3.2%, 4.2%, and 3.2% in the ranibizumab treated-initial, ranibizumab treated-XO, and ranibizumab untreated groups, respectively. Cataract AEs were less frequent in the ranibizumab untreated group: 6.3% versus 12.5% and 12.1% in the ranibizumab treated-initial and ranibizumab treated-XO groups, respectively. The proportion of patients with arterial thromboembolic events as defined by the Antiplatelet Trialists' Collaboration was 5.3% in the ranibizumab treated-initial and ranibizumab treated-XO groups, and 3.2% in the ranibizumab untreated group. At month 48 (2 years of HORIZON), the mean change in BCVA (ETDRS letters) relative to the initial study baseline was 2.0 in the ranibizumab treated-initial group versus -11.8 in the pooled ranibizumab treated-XO and ranibizumab untreated groups.Conclusions Multiple ranibizumab injections were well tolerated for ≥4 years. With less frequent follow-up leading to less treatment, there was an incremental decline of the visual acuity (VA) gains achieved with monthly treatment.Financial disclosure(s) Proprietary or commercial disclosure may be found after the references.

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Metadata

Authors
Singer, M. A., Awh, C. C., Sadda, S., Freeman, W. R., Antoszyk, A. N., Wong, P., & Tuomi, L.
Affiliations
  • Medical Center Ophthalmology Associates (US)
  • Tennessee Retina (US)
  • Doheny Eye Institute (US)
  • University of California San Diego (US)
  • Charlotte Eye Ear Nose & Throat Associates (US)
  • Genentech (US)
Corresponding author
Singer, Michael A.
ORCID
Venue
Ophthalmology
Publisher
Elsevier BV
Published
2012-06
Volume
119
Issue
6
Pages
1175-1183
ISSN
0161-6420 (ISSN-L)
DOI
10.1016/j.ophtha.2011.12.016
OpenAlex
W2011393181
Cited by
356
References
14
Citations by year
2026: 6 · 2025: 9 · 2024: 17 · 2023: 10 · 2022: 24 · 2021: 27 · 2020: 37 · 2019: 32 · 2018: 23 · 2017: 34 · 2016: 30 · 2015: 31 · 2014: 36 · 2013: 29 · 2012: 10
FWCI
31.69
Type
journal article
Language
en
Open access
closed
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations
  • Ophthalmology (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Ophthalmology › Retinal Diseases and Treatments
  • Health Sciences › Medicine › Ophthalmology › Retinal and Macular Surgery
  • Health Sciences › Medicine › Ophthalmology › Ocular Diseases and Behçet’s Syndrome
Keywords
ranibizumab, choroidal neovascularization, age-related macular degeneration, intravitreal injection, long-term safety, adverse events, endophthalmitis, intraocular pressure, glaucoma, cataract, visual acuity, anti-VEGF therapy, HORIZON trial, lens damage, retinal tears, retinal detachment
MeSH terms
Ranibizumab, Aged, Female, Follow-Up Studies, Humans, Macular Degeneration, Male, Visual Acuity, Treatment Outcome, Choroidal Neovascularization, Angiogenesis Inhibitors, Vascular Endothelial Growth Factor A, Intravitreal Injections, Antibodies, Monoclonal, Humanized

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