Intraocular pressure in eyes receiving monthly ranibizumab in 2 pivotal
age-related macular degeneration clinical trials.
Author(s): Bakri SJ(1), Moshfeghi DM(2), Francom S(3), Rundle AC(3), Reshef DS(3), Lee
PP(4), Schaeffer C(3), Rubio RG(3), Lai P(3).
Affiliation(s): Author information:
(1)Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota. Electronic
address: bakri.sophie@mayo.edu.
(2)Horngren Family Vitreoretinal Center, Department of Ophthalmology, Byers Eye
Institute at Stanford University, Stanford University School of Medicine, Palo
Alto, California.
(3)Genentech, Inc., South San Francisco, California.
(4)Kellogg Eye Center, Department of Ophthalmology and Visual Sciences, University
of Michigan, Ann Arbor, Michigan.
Publication date & source: 2014, Ophthalmology. , 121(5):1102-8
PURPOSE: To characterize preinjection intraocular pressure (IOP) in eyes
receiving monthly ranibizumab versus sham or verteporfin photodynamic therapy
(PDT) for age-related macular degeneration (AMD).
DESIGN: Post hoc analysis of IOP data from 2 phase 3 clinical trials, the
Minimally Classic/Occult Trial of the Anti-VEGF Antibody Ranibizumab in the
Treatment of Neovascular AMD (MARINA) and the Anti-VEGF Antibody for the
Treatment of Predominantly Classic Choroidal Neovascularization in AMD (ANCHOR)
trial.
PARTICIPANTS: All safety-evaluable patients who received 1 or more injections of
sham or PDT or of ranibizumab and had 1 or more postbaseline IOP measurements
recorded for the study eye.
METHODS: Preinjection IOP measurements for study eyes (n = 1125) and fellow eyes
in MARINA and ANCHOR at baseline and at each monthly visit through month 24 were
analyzed.
MAIN OUTCOME MEASURES: End points evaluated were maximum preinjection IOP during
the 24-month treatment period; any occurrence of absolute preinjection IOP of 21
mmHg or more, 25 mmHg or more, or 30 mmHg or more; any occurrence of IOP increase
of 6 mmHg or more, 8 mmHg or more, or 10 mmHg or more from baseline; any
combination of IOP increase of 6 mmHg or more or 8 mmHg or more from baseline
with concurrent absolute preinjection IOP of 21 mmHg or more or 25 mmHg or more;
glaucoma-related adverse events; new glaucoma medications used for 45 days or
more; and glaucoma filtration or laser surgeries.
RESULTS: Across treatment groups, 60.1% to 70.9% of study eyes had a maximum
preinjection IOP of less than 21 mmHg. Comparing ranibizumab 0.5 mg versus sham
or PTD treatment, respectively: 39.9% versus 29.1% and 10.9% versus 5.1% had
maximum preinjection IOPs of 21 mmHg or more or 25 mmHg or more, respectively;
44.1% versus 29.9% and 24.2% versus 13.6% had IOP increases from baseline of 6
mmHg or more or 8 mmHg or more, respectively; 26.1% versus 13.6% and 16.8% versus
9.0% had 1 or more IOP increase from baseline of 6 mmHg or more or 8 mmHg or
more, respectively, with a concurrent IOP of 21 mmHg or more; 9.6% versus 3.7%
and 7.5% versus 2.4% had 1 or more IOP increase from baseline of 6 mmHg or more
or 8 mmHg or more, respectively, with a concurrent IOP of 25 mmHg or more. No
differences were observed in fellow eyes.
CONCLUSIONS: Most ranibizumab-treated eyes did not experience sustained
preinjection IOP of 21 mmHg or more (>2 consecutive visits) over 24 months. When
evaluating the combined IOP end point, more ranibizumab-treated eyes had 1 or
more IOP increase from baseline of 6 mmHg or more or 8 mmHg or more, with
concurrent highest IOPs of 21 mmHg or more and 25 mmHg or more versus sham or
PDT. Intraocular pressure should be monitored in eyes receiving ranibizumab.
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