Eyes and Vision - The Royal Wolverhampton NHS Trust Library ...

Volume1, Issue 9
October, 2012
Latest Updates for Eyes
and Vision...
NHS Trust
Welcome to
Ophthalmology
The latest Evidence
Newsletter...
Inside this Issue:
page2 Intravitreal
aflibercept (VEGF
Trap eye) in wet agerelated
macular degeneration
Page2 NEWS...Library
blog and website
Page3 FDA approves
first “non-surgical
treatment” for vitreomacular
adhesion
Page3 PPV safe for
irradiated uveal
melanoma
Page3 Updated topics
on UpToDate
Page4
Specialties
Page4 Latest news
in Ophthalmology
Evidence Update
Antibiotics versus
placebo for acute
bacterial conjunctivitis
(Cochrane database
systematic review)
Link
NICE publishes new draft guidance on ranibizumab
for diabetic macular oedema after rapid review
Draft guidance from NICE has recommended ranibizumab as an option for treating visual
impairment caused by diabetic macular oedema (DMO). NICE conducted a rapid review of the
original guidance, published in November 2011, because the manufacturer submitted a revised
Patient Access Scheme, together with updated analyses including the drug's superior relative
effect among a sub-group of people with DMO.
The appraisal consultation document (ACD) makes the following recommendations:
1. Ranibizumab is recommended as an option for treating visual impairment due to diabetic
macular oedema only if:
the person has a central retinal thickness of 400 micrometres or more and
the manufacturer provides ranibizumab with the discount agreed as part of the patient access
scheme (as revised in 2012).
2. People currently receiving ranibizumab who do not have a central retinal thickness of 400
micrometres or more should be able to continue treatment until they and their clinician consider it
appropriate to stop.
In the press release, the Health Technology Evaluation Centre Director at NICE said: "Our current
guidance on the use of ranibizumab for treating visual impairment caused by diabetic macular
oedema, published in November 2011, does not recommend the drug as an effective use of NHS
resources. However, following the submission of a revised patient access scheme, we have
conducted a rapid review of the original guidance. The manufacturer included updated analyses
showing that ranibizumab could be expected to have a superior relative effect among people with
central retinal thickness greater than 400 micrometres. This draft guidance recommending
ranibizumab for some patients with diabetic macular oedema is now available for consultation."
(Summary by Devika Sennik,NeLM)
Link to press release
Draft Guidance ACD
Current NICE guidance on ranibizumab for DMO—November 2011 (TA237)
Long term safety of ranibizumab in neovascular
age-related macular degeneration: SECURE Study
Abstract:
Participants
Two hundred thirty-four patients previously treated with ranibizumab for 12 months in the EXCITE/
SUSTAIN study.
Methods
Ranibizumab 0.5 mg administered at the investigator's discretion as per the European summary of
product characteristics 2007 (SmPC, i.e., ranibizumab was administered if a patient experienced a
best-corrected visual acuity [BCVA] loss of >5 Early Treatment Diabetic Retinopathy Study letters
measured against the highest visual acuity [VA] value obtained in SECURE or previous studies
[EXCITE and SUSTAIN], attributable to the presence or progression of active nAMD in the
investigator's opinion).
Main Outcome Measures
Incidence of ocular or nonocular adverse events (AEs) and serious AEs, mean change in BCVA
from baseline over time, and the number of injections.
(continued over page)

Results
Of 234 enrolled patients, 210 (89.7%) completed the study. Patients received 6.1 (mean) ranibizumab injections over 24 months.
Approximately 42% of patients had 7 or more visits at which ranibizumab was not administered, although they had experienced a
VA loss of more than 5 letters, indicating either an undertreatment or that factors other than VA loss were considered for
retreatment decision by the investigator. The most frequent ocular AEs (study eye) were retinal hemorrhage (12.8%; 1 event
related to study drug), cataract (11.5%; 1 event related to treatment procedure), and increased intraocular pressure (6.4%; 1
event related to study drug). Cataract reported as serious due to hospitalization for cataract surgery occurred in 2.6% of patients;
none was suspected to be related to study drug or procedure. Main nonocular AEs were hypertension and nasopharyngitis (9.0%
each). Arterial thromboembolic events were reported in 5.6% of the patients. Five (2.1%) deaths occurred during the study, none
related to the study drug or procedure. At month 24, mean BCVA declined by 4.3 letters from the SECURE baseline.
Conclusions
The SECURE study showed that ranibizumab administered as per a VA-guided flexible dosing regimen recommended in the
European ranibizumab SmPC at the investigator's discretion was well tolerated over 2 years. No new safety signals were
identified in patients who received ranibizumab for a total of 3 years. On average, patients lost BCVA from the SECURE study
baseline, which may be the result of disease progression or possible undertreatment.
Link to Full Text ( Original article available on-line 25.09.2012 via Science Direct Athens log in required)
Intravitreal aflibercept (VEGF Trap-Eye) in wet age-related macular
degeneration
Reference: Ophthalmology, published early online on 17 October 2012
Abstract:
Objective
Two similarly designed, phase-3 studies (VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD [VIEW 1, VIEW 2]) of
neovascular age-related macular degeneration (AMD) compared monthly and every-2-month dosing of intravitreal aflibercept
injection (VEGF Trap-Eye; Regeneron, Tarrytown, NY, and Bayer HealthCare, Berlin, Germany) with monthly ranibizumab.
Design
Double-masked, multicenter, parallel-group, active-controlled, randomized trials.
Participants
Patients (n = 2419) with active, subfoveal, choroidal neovascularization (CNV) lesions (or juxtafoveal lesions with leakage
affecting the fovea) secondary to AMD.
Intervention
Patients were randomized to intravitreal aflibercept 0.5 mg monthly (0.5q4), 2 mg monthly (2q4), 2 mg every 2 months after 3
initial monthly doses (2q8), or ranibizumab 0.5 mg monthly (Rq4).
Main Outcome Measures
The primary end point was noninferiority (margin of 10%) of the aflibercept regimens to ranibizumab in the proportion of patients
maintaining vision at week 52 (losing

FDA approves 'first nonsurgical
treatment' for
vitreomacular adhesion
The US Food and Drug Administration (FDA) reports the
approval of ocriplasmin for the treatment of symptomatic
vitreomacular adhesion (VMA).
The safety and efficacy of the drug have been previously
assessed in two randomized controlled trials published in the
New England Journal of Medicine, which involved over 600
patients with the condition, and showed a significantly higher
rate of VMA resolution after ocriplasmin versus placebo.
(abstract to this trial was referred to in August’s Newsletter)
Link to abstract
Edward Cox, director of the Office of Antimicrobial Products
in the FDA’s Centre for Drug Evaluation and Research said,
"Today's approval represents a significant advancement in
treatment for patients with symptomatic VMA. Those with
this sight-threatening disease now have a non-surgical
treatment option."
"Ocriplasmin is a recombinant protease with activity against
fibronectin and laminin, components of the vitreoretinal
interface," explain Julia Haller (Willis Eye Institute,
Philadelphia, Pennsylvania) and colleagues, authors of the
clinical trials.
The alternative treatment for VMA is vitrectomy, notes the
FDA statement, a surgical procedure that involves cutting
the vitreous gel in the eye and sucking it out.
In Haller et al's study, vitreomacular adhesion resolved in
26.5% of 464 VMA patients treated with a single injection of
ocriplasmin, compared with 10.1% of 188 placebo-injected
patients. In addition, the research team found that total
posterior vitreous detachment was significantly more
frequent among patients who had received ocriplasmin than
those who had received placebo, at 13.4% versus 3.7%.
However, the researchers report a higher rate of ocular
adverse events in ocriplasmin-treated eyes over the 6-month
follow-up period, including vitreous floaters, photopsia
(flashes of light), injection-related eye pain, blurred or
unclear vision, and conjunctival bleeding. Despite this, the
rate of serious adverse events was similar in both groups.
"Intravitreal injection of ocriplasmin was superior to injection
of placebo in altering the vitreoretinal interface of affected
eyes, although it was accompanied by some, mainly
transient, ocular adverse events," conclude Haller and coinvestigators.
New major UK eye care institution joins
Map of Medicine
The College of Optometrists will join
the Royal College of Ophthalmologists,
to accredit National Eye Care Pathways.
The first joint accreditations are
expected early next year.
PPV safe for irradiated uveal
melanoma
Ophthalmology Times Europe…...
Pars plana vitrectomy is safe to use on patients with plaqueirradiated
uveal melanoma, according to a study in the
Archives of Ophthalmology.
The retrospective case series, headed by Dr Alok S. Bansal,
Department of Immunology, St Helier Hospital, Carshalton,
Surrey, UK, included 47 eyes of 47 patients with plaqueirradiated
posterior uveal melanoma who underwent PPV for
vitreous haemorrhage.
The primary outcome measures included rates of intraocular
melanoma dissemination, extrascleral extension of
melanoma, local melanoma recurrence and systemic
melanoma metastasis after PPV.
No cases of intraocular melanoma dissemination or
extrascleral extension of melanoma were found. Local
choroidal melanoma recurrence was found in one patient
and was successfully managed with transpupillary
thermotherapy.
After a mean interval of five years after plaque radiotherapy,
four patients experienced systemic melanoma metastasis.
The management of vitreous haemorrhage using PPV is
safe and doesn’t increase the risk of intraocular, local, orbital
or systemic dissemination of the tumour in patients with
uveal melanoma
Link to abstract of study in Archives of Ophthalmology
(full text available to read in Eye Library)
UpToDate
The following topics have recently been updated on
UpToDate!
Select the titles to access full topic (only available via Royal
Wolverhampton Internet)
Allergic Conjunctivitis (updated 04/10/2012)
Traumatic Hyphema: Clinical Features and
Management (updated 07/09/2012)
Tubulointerstital nephritis and Uveitis (TINU
Syndrome) (Updated 08/09/2012)
Open angle glaucoma: Treatment
(updated 25/09/2012)
Clinical Features and diagnosis of Fabry Disease
(updated 26/09/2012)
Retinal vasculitis associated with Systematic
Disorders and Infections (updated 29/08/2012)
Etiology and Evaluation of Microcephaly in Infants
and young Children (updated 10/09/2012)
Visual Development and Visual Assessment in
Infants and Children (updated 07/08/2012)

Specialties
Glaucoma…
Macular scan OCT could be used for glaucoma and
should be considered as a tool for the diagnosis and management
of glaucoma, due to the predictable and significant structural
relationship between macular thickness and VF defects.
Abstract available in Journal of Glaucoma
Anti-glaucoma eye drops linked to meibomian gland
changes The long-term use of anti-glaucoma eye drops is
linked to changes in meibomian gland morphology and function,
according to a paper published in the journal Cornea.
Link to abstract
Cataract…
Corneal astigmatism and HOAs affect IOL performance
Uncorrected corneal astigmatism and higher-order aberrations
(HOAs) in pseudophakic eyes significantly affects
through-focus performance of presbyopia-correcting IOLs.
Abstract available in
Journal of Cataract and Refractive Surgery
Dexamethasone protects against membrane formation
Dexamethasone protects against anterior membrane formation
and doesn’t increase glaucoma risk.
Abstract available in
Journal of Cataract and Refractive Surgery
Cornea….
Pranoprofen benefits dry eyes Topical pranoprofen 0.1%
reduces the ocular signs and symptoms of dry eyes and decreases
inflammatory markers of conjunctival epithelial cells,
according to a study in the latest journal of Cornea
Link to abstract
DALK with hydrops is safe and effective Deep anterior
lamellar keratoplasty (DALK) is a safe and effective procedure
in keratoconic eyes with previous hydrops.
This study can be found in the
British Journal of Ophthalmology
Retina…
Prophylactic treatment of retinal breaks reduces RD risk
Prophylactic treatment of retinal breaks during vitrectomy
appears to reduce the risk of postoperative retinal detachment
(RD), states a paper in Retina.
Link to article
Latest News
Repetitive probing identifies nasolacrimal duct
obstructions Repetitive probing with intranasal endoscopic
imaging provides information about congenital
nasolacrimal duct obstructions, claims a paper in the
European Journal of Ophthalmology.
Link to abstract
(full text will be available in December)
Instrument-Based Vision Screening Best in 3-5year
olds NEW YORK (Reuters Health) Oct 30 - A new policy
statement from the American Academy of Pediatrics published
Monday recommends photoscreening and handheld
autorefraction as an alternative to visual acuity screening
with vision charts in children aged three to five years old.
Link to full policy statement in Pediatrics
Simple eye tests accurately identify schizophrenia
Using a series of simple eye tests to identify abnormal eye
movements may help clinicians to distinguish patients with
schizophrenia from those without, new research suggests.
Link to abstract
UK Lacks Pathways Through Social and Clinical Care
for Eye Patients
UK study results reveal that emotional and family support
is lacking for individuals with visual impairment.
The survey of clinical and rehabilitation staff working at
eye clinics and in the community showed discrepancies in
opinions over what constitutes essential services for visually
impaired patients, and which type of personnel provides
such services.
Eye 2012; 26: 1302‐1309
Link to Abstract
Gas Superior to Air Tamponade in Lower Quadrant
Vitrectomy
Gas and air are suitable tamponading agents for use during
vitrectomy for rhegmatogenous retinal detachment (RRD),
however air tamponade should only be used in cases that
are restricted to the superior quadrants, study findings
show.
Advance on-line publication –British J. of Ophth. 2012
Link to full text