HORIZON: an open-label extension trial of ranibizumab for choroidal neovascularization secondary to age-related macular degeneration
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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In the HORIZON cohort, participants had better visual acuity and lesion characteristics than non-participants.
“Comparison of participants to non-participants in this cohort showed that visual acuity and lesion characteristics were better for participants”
From Five-Year Outcomes with Anti–Vascular Endothelial Growth Factor Treatment of Neovascular Age-Related Macular Degeneration (2016) · cites this paper as [19]
Only 388 (65%) of the 600 selected HORIZON participants had 4-year follow-up.
“only 388 (65%) of these selected 600 participants had 4-year follow-up.”
From Five-Year Outcomes with Anti–Vascular Endothelial Growth Factor Treatment of Neovascular Age-Related Macular Degeneration (2016) · cites this paper as [19]
In HORIZON, patients were eligible only if their ophthalmologist thought continued ranibizumab beyond the 2-year trial would help.
“participants were eligible for the HORIZON study only if their ophthalmologist believed that further treatment with ranibizumab beyond the 2-year clinical trial period would be beneficial.19”
From Five-Year Outcomes with Anti–Vascular Endothelial Growth Factor Treatment of Neovascular Age-Related Macular Degeneration (2016) · cites this paper as [19]
In HORIZON, mean visual acuity fell 7 letters to 20/80, with an average of 4 injections over the 2 years after leaving the formal trials.
“Similarly, in HORIZON, mean visual acuity declined by 7 letters to 20/80 with total 4 injections on average during the 2 years following exit from the formal clinical trials.19”
From Five-Year Outcomes with Anti–Vascular Endothelial Growth Factor Treatment of Neovascular Age-Related Macular Degeneration (2016) · cites this paper as [19]
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- 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.
- Venue
- Ophthalmology
- Publisher
- Elsevier BV
- Published
- 2012-06
- Volume
- 119
- Issue
- 6
- Pages
- 1175-1183
- ISSN
- 0161-6420 (ISSN-L)
- 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
- Locations
- Ophthalmology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Ophthalmology › Retinal Diseases and Treatments
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › 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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