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Ophthalmology. 2015 Dec;122(12):2497-503. doi: 10.1016/j.ophtha.2015.08.014. Epub 2015 Oct 21.

Scheduled versus Pro Re Nata Dosing in the VIEW Trials.

Author information

1
Department of Ophthalmology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. Electronic address: richard@uke.de.
2
Institut de la Macula i de la Retina, Hospital Quiron Teknon, Barcelona, Spain, and Barcelona Macula Foundation, Barcelona, Spain.
3
Department of Ophthalmology, University Hospital Bern, Inselspital, University of Bern, Bern, Switzerland.
4
Service d'Ophtalmologie, Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France; Institut de Santé Publique, d'Epidémiologie et de Développement, Université de Bordeaux, Bordeaux, France; Centre Epidemiologie-Biostatistique, Institut National de la Santé et de la Recherche Médicale, Bordeaux, France.
5
Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, University of Melbourne, Melbourne, Australia.
6
Tel Aviv Medical Center, Tel Aviv, Israel, and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
7
Bayer Pharma AG, Berlin, Germany.
8
Bayer Pharma AG, Berlin, Germany; Department of Neurology, Heinrich-Heine University, Düsseldorf, Germany.
9
Department of Ophthalmology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Bayer Pharma AG, Berlin, Germany.

Abstract

PURPOSE:

To analyze visual acuity (VA) outcomes before and after preplanned treatment regimen change in the VIEW studies at week 52 (W52).

DESIGN:

Multiple post hoc analyses for retrospectively defined subgroups in 2 multicenter, multinational, double-masked trials.

PARTICIPANTS:

Two thousand four hundred fifty-seven neovascular age-related macular degeneration (AMD) patients.

METHODS:

Patients were randomized to treatment with 0.5 mg ranibizumab given monthly, a 0.5-mg or 2-mg intravitreal aflibercept injection given monthly, or 2 mg intravitreal aflibercept given every other month, after 3 initial monthly doses, up to W52. From W52 through W96, patients received their original dosing assignment using a capped pro re nata (PRN) regimen, with defined retreatment criteria based on VA and morphologic signs of disease activity and mandatory dosing at least every 12 weeks.

MAIN OUTCOME MEASURES:

Best-corrected VA (BCVA) and optical coherence tomography assessments were mandatory at all visits from baseline to W96. Outcomes were changes in BCVA and central retinal thickness. Outcomes were evaluated in all patients who completed 2 years of the VIEW studies using the last observation carried forward method for missing data at interim visits.

RESULTS:

After W52, approximately 20% of patients lost 5 Early Treatment Diabetic Retinopathy Study (ETDRS) letters or more across all treatment arms with PRN treatment. Patients who met the retreatment criterion of loss of 5 ETDRS letters or more in the first quarter of the PRN dosing phase did not recover; mean final VA loss across the 4 study arms was -4.4 to -5.8 letters. Outcomes of these patients up to W52 were indistinguishable from those of the overall population. There were no differences between groups in serious ocular adverse events or Anti-Platelet Trialists' Collaboration arterial thromboembolic events through W96.

CONCLUSIONS:

These analyses suggest that there are subgroups of patients for whom VA outcomes in the second year of the VIEW studies were less stable than in the first year and for whom W52 seems to be an important inflection point. Although alternate reasons specific to the nature of the underlying AMD cannot be fully excluded, the switch in treatment regimen at W52 is a plausible explanation.

PMID:
26477840
DOI:
10.1016/j.ophtha.2015.08.014
[Indexed for MEDLINE]

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