Original articleRanibizumab for Macular Edema Due to Retinal Vein Occlusions: Long-term Follow-up in the HORIZON Trial
Section snippets
Study Design and Patient Population
HORIZON (ClinicalTrials.gov identifier: NCT00379795) was an open-label, single-arm, multicenter extension trial that was conducted in accordance with the Declaration of Helsinki, applicable US Food and Drug Administration (FDA) regulations, and the Health Insurance Portability and Accountability Act. The study protocol was approved by the respective institutional review boards before study initiation, and all participating patients provided informed consent. Patients with RVO were eligible for
Patient Characteristics and Disposition
The RVO cohort of HORIZON enrolled 608 patients (Fig 1, available at http://aaojournal.org). Approximately 85% of patients who completed BRAVO (n = 304; sham/0.5 mg = 97; 0.3/0.5 mg [defined as patients who received 0.3 mg in BRAVO or CRUISE and received 0.5 mg during HORIZON] = 103; 0.5 mg = 104) and 87% of patients who completed CRUISE (n = 304; sham/0.5 mg = 98; 0.3/0.5 mg = 107; 0.5 mg = 99) participated in HORIZON. Patient demographics and baseline characteristics for the study eye by
Discussion
Overall, this study found that long-term use of intravitreal injections of 0.5 mg ranibizumab administered on an as-needed basis were well-tolerated in patients with macular edema secondary to RVO. These results are consistent with previous findings.5, 6 No new safety events were identified.
Among patients who have had a BRVO or CRVO for <12 months, on average, injections of ranibizumab every month for 6 months resulted in marked improvement in BCVA and macular edema compared with sham
Acknowledgments
This study was funded by Genentech, Inc. Support for third-party writing assistance for this manuscript, provided by Rebecca Jarvis, PhD, of Envision Scientific Solutions, was provided by Genentech, Inc.
References (16)
- et al.
Retinal vein occlusion: beyond the acute event
Surv Ophthalmol
(2011) - et al.
Ranibizumab for macular edema due to retinal vein occlusions: implication of VEGF as a critical stimulator
Mol Ther
(2008) - et al.
Sustained benefits from ranibizumab for macular edema following branch retinal vein occlusion: 12-month outcomes of a phase III study
Ophthalmology
(2011) - et al.
Sustained benefits from ranibizumab for macular edema following central retinal vein occlusion: twelve-month outcomes of a phase III study
Ophthalmology
(2011) - et al.
Monitoring ocular drug therapy by analysis of aqueous samples
Ophthalmology
(2009) - et al.
Treatment of macular edema due to retinal vein occlusions
Clin Ophthalmol
(2011) - et al.
Vitreous inflammatory factors in macular edema with central retinal vein occlusion
Jpn J Ophthalmol
(2011) - et al.
Ranibizumab for macular edema following branch retinal vein occlusion: six-month primary end point results of a phase III study
Ophthalmology
(2010)
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Manuscript no. 2011-983.
Financial Disclosure(s): The author have made the following disclosures: Jeffrey S. Heier - Consultant - Acucela, Alcon, Allergan, Forsight Labs, Fovea, Genentech, Genzyme, GlaxoSmithKline, Neovista, Notal, Oraya, Paloma, Pfizer, Regeneron, and Sequenom; Research funding - Alimera, Alcon, Allergan, Genentech, Genzyme, GlaxoSmithKline, Molecular Partners, Neovista, Notal, Novartis, Ophthotech, Paloma, Pfizer, Regeneron. Peter A. Campochiaro - Consultant - Allergan, Amira, Genentech, Inc, GlaxoSmithKline, LPath; Research fundingGlaxoSmithKline, LPath - Alcon Laboratories, Alimera, Allergan, Amira, GlaxoSmithKline, and Lpath. Linda Yau - Employee - Genentech. Zhengrong Li - Employee - Genentech. Namrata Saroj - Employee - Genentech. Roman Rubio - Employee - Genentech. Phillip Lai - Employee - Genentech. Genentech, Inc., South San Francisco, CA, provided support for the study, participated in study design, conducted the study, and provided data collection, management, and interpretation.