185
Anti-VEGF in the treatment of AMD
myocardial infraction regardless of treatment.
Any potential safety concerns remain unknown and
waiting for randomized and controlled clinical trials.
5.4 Discussion
The initial results of intravitreal bevacizumab for exuda-
tive AMD led to the acceptance of this off-label therapy
by ophthalmologists around the world, assuming, based
on case series evidence, that bevacizumab is at least
almost as good as ranibizumab with respect to efficacy
and safety. Some ophthalmologists might recommend
bevacizumab instead of ranibizumab, even when it is
available and affordable to the patient, because of the
concerns regarding the treatment costs
(84, 92)
.
Intravitreal bevacizumab accounts for more than 50% of
all anti-VEGF therapy delivered for exudative AMD in
the United States
(109)
.
The National Eye Institute is sponsoring a clinical trial
to compare the safety and efficacy betwen bevacizumab
and ranibizumab for the treatment of exudative AMD –
CATT
study. This study and other prospective, controlled
and randomized trials in several countries (
IVAN
-UK,
VIBERA
-Germany,
MANTA
-Austria,
LUCAS
-Norway,
GEFAL
-France) will provide the best level of evidence
regarding the efficacy and safety of bevacizumab. Some
of these ongoing studies can give consistent information
about the necessary dose-ranging and dosing-frequency
to control AMD neovascularization.
6. Nice recommendations
(57)
(National Institute for Health and Clinical
Excellence; April 2008)
According to
NICE
, ranibizumab is the only anti-
VEGF recommended for the treatment of Age-related
Macular Degeneration (as per the
NICE
Guidelines,
published in 2008).
Differences are clear when comparing the outcomes
of clinical programs for both drugs (ranibizumab and
pegaptanib). In clinical trials with ranibizumab, the
percentage of patients who gained 15 letters or more
was substantially higher, whereas in clinical trials with
pegaptanib few patients gained 15 letters or more com-
pared to the control group.
Regarding visual acuity outcomes (expressed as the aver-
age number of letters lost or gained by both treatment
groups versus the control group), the observed results
revealed that ranibizumab leads to statistically signifi-
cant average gains, whereas pegaptanib only leads to a
decrease in the average loss, i.e., ranibizumab is more
effective than pegaptanib regarding improvements in
visual acuity. Additionally, no benefits were observed in
patients whose treatment with pegaptanib was discon-
tinued after the first year, when compared to patients
in the placebo group (
VISION
study results, published
in 2006).
According to
NICE
, both drugs (ranibizumab and
pegaptanib) have demonstrated clinical efficacy in the
treatment of exudative AMD, although ranibizumab
leads to increased clinical benefits and pegaptanib fails to
represent a cost-effective example of healthcare resource
use, thus not being recommended in the treatment of
AMD. On the contrary, ranibizumab is referred as an
option in the treatment of this condition, providing the
following are observed for the treated eye:
- visual acuity between 6/12 and 6/96
- no permanent structural damage to the central
fovea
- lesion size less than or equal to 12 disc areas in its
greatest linear dimension
- evidence of recent disease progression (vessel pro
liferation, observed in fluorescein angiography, or
recent changes in visual acuity).
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