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NICE publishes new draft guidance on ranibizumab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Draft guidance from NICE has recommended ranibizumab as an option for treating visual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 This draft guidance recommending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)

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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

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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