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HORIZON: an open-label extension trial of ranibizumab for choroidal neovascularization secondary to age-related macular degeneration.

Publication ,  Journal Article
Singer, MA; Awh, CC; Sadda, S; Freeman, WR; Antoszyk, AN; Wong, P; Tuomi, L
Published in: Ophthalmology
June 2012

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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Published In

Ophthalmology

DOI

EISSN

1549-4713

Publication Date

June 2012

Volume

119

Issue

6

Start / End Page

1175 / 1183

Location

United States

Related Subject Headings

  • Visual Acuity
  • Vascular Endothelial Growth Factor A
  • Treatment Outcome
  • Ranibizumab
  • Ophthalmology & Optometry
  • Male
  • Macular Degeneration
  • Intravitreal Injections
  • Humans
  • Follow-Up Studies
 

Citation

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Singer, M. A., Awh, C. C., Sadda, S., Freeman, W. R., Antoszyk, A. N., Wong, P., & Tuomi, L. (2012). HORIZON: an open-label extension trial of ranibizumab for choroidal neovascularization secondary to age-related macular degeneration. Ophthalmology, 119(6), 1175–1183. https://doi.org/10.1016/j.ophtha.2011.12.016
Singer, Michael A., Carl C. Awh, SriniVas Sadda, William R. Freeman, Andrew N. Antoszyk, Pamela Wong, and Lisa Tuomi. “HORIZON: an open-label extension trial of ranibizumab for choroidal neovascularization secondary to age-related macular degeneration.Ophthalmology 119, no. 6 (June 2012): 1175–83. https://doi.org/10.1016/j.ophtha.2011.12.016.
Singer MA, Awh CC, Sadda S, Freeman WR, Antoszyk AN, Wong P, et al. HORIZON: an open-label extension trial of ranibizumab for choroidal neovascularization secondary to age-related macular degeneration. Ophthalmology. 2012 Jun;119(6):1175–83.
Singer, Michael A., et al. “HORIZON: an open-label extension trial of ranibizumab for choroidal neovascularization secondary to age-related macular degeneration.Ophthalmology, vol. 119, no. 6, June 2012, pp. 1175–83. Pubmed, doi:10.1016/j.ophtha.2011.12.016.
Singer MA, Awh CC, Sadda S, Freeman WR, Antoszyk AN, Wong P, Tuomi L. HORIZON: an open-label extension trial of ranibizumab for choroidal neovascularization secondary to age-related macular degeneration. Ophthalmology. 2012 Jun;119(6):1175–1183.
Journal cover image

Published In

Ophthalmology

DOI

EISSN

1549-4713

Publication Date

June 2012

Volume

119

Issue

6

Start / End Page

1175 / 1183

Location

United States

Related Subject Headings

  • Visual Acuity
  • Vascular Endothelial Growth Factor A
  • Treatment Outcome
  • Ranibizumab
  • Ophthalmology & Optometry
  • Male
  • Macular Degeneration
  • Intravitreal Injections
  • Humans
  • Follow-Up Studies