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HKC-LUC-L379-1012b
Understanding
Retina
Dry AMD
Iris
Anterior chamber
Macula
Lens
Vitreous gel
Optic nerve
Pupil
Cornea
Ciliary body
Wet AMD
Abnormal blood vessel growth
Blood and fluid leak into the retina,
causing distortion of vision
This form causes severe vision loss
Age
Your risk of macular degeneration increases
with age. About one third of adults aged 75
years or older are affected by AMD
Gender
Women are more likely to develop AMD
than men
Smoking
Smoking increases an individuals chance
of developing AMD by two- to five-fold
High blood pressure
High blood pressure leads to narrowing of
the blood vessels that nourish the retina
High cholesterol
An elevated cholesterol level in blood is
associated with increased risk of AMD
Obesity
Severely overweight individuals are more likely to
be affected by AMD
Prolonged sun exposure
High exposure to sunlight and ultraviolet light is a
risk factor of AMD
3
Intravitreal injections1
Mechanism: Intravitreal injection blocks vascular endothelial
growth factor (VEGF) which leads to the growth of abnormal blood
vessels
Procedure:
Sterilization and anaesthesia of the eyes
Direct injection of an anti-VEGF drug into the eyes
Injection is performed once a month until vision
becomes stable
Consult your ophthalmologist for details
Lucentis (Ranibizumab)
Efficacy 3,7
More than 90% of
patients maintain and
improve vision
Efficacy can be
maintained for up to two
years
Improves vision-related
quality of life
Safety 3,8*
Multiple intravitreal
injections of ranibizumab
were well tolerated for
4 or more years
Only a small number of
patients suffered from
adverse events
* Please refer to the product information for
details on drug safety
Number of letters
0
-5
-10
-15
+6.6
Control group
21.5
letters
difference
Lucentis -treated
group
MARINA Study
10
5
-14.9
VISUDYNE
Presentation: Verteporfin: 15 mg, powder for solution for infusion.
Indications:
Visudyne is used for the treatment of
Patients with exudative (wet) age-related macular degeneration (AMD) with
predominantly classic subfoveal choroidal neovascularisation (CNV) or
Patient with subfoveal choroidal neovascularisation secondary to pathological myopia
Dosage: Visudyne therapy is a two-step process. The first step is a 10-minute intravenous infusion of Visudyne at a dose of 6 mg/m2 body surface area,
diluted in 30ml infusion. The second step is the light activation of Visudyne
at 15 minutes after the start of the infusion. For this, a diode laser generating non-thermal red light (wavelength 689 nm 3 nm is used via a slit lamp
mounted fibre optic device and a suitable contact lens, At the recommended
light intensity 600 mW/cm2 , it takes 83 seconds to deliver the required light
dose of 50J/cm2.
Patients should be re-evaluated every 3 months and receive an additional
treatment in the event of recurrent CNV leakage.
Contraindications: Visudyne is contraindicated for patients with porphyria
or a known hypersensitivity to verteporfin or to any of the excipients of Visudyne.
Precautions/Warnings: Patients who receive Visudyne will become photosensitive for up to 48 hours after the infusion. Caution should be exercised
in patients with moderate to severe hepatic impairment or biliary obstruction.
Patients who experience a severe decrease of vision (equivalent to 4 lines
or more) within one week after treatment should not receive another treatment, at least until their vision completely recovers to pre-treatment level.
Avoid extravasation. Patients should be under medical supervision during the
Visudyne infusion. Only compatible lasers should be used.
Visudyne should be used in pregnant women only if the benefit to the mother
justifies the potential risk to the foetus. In breast-feeding women, treatment
should be postponed or breast-feeding interrupted for at least 48 hours. The
decision should take into consideration the importance of the drug to the
mother and the consequences of breast feeding interruption to both the baby
and the mother. Following treatment patients may develop transient visual
disturbances that may interfere with their ability to drive or use machines.
Patients should not drive or use machines as long as these symptoms persist.
Overdose of drug and/or light in the treated eye may result in non-selective
non-perfusion of normal retinal vessels with the possibility of severe vision
decrease. Overdose may also result in the prolongation of the period during
which the patient remains photosensitive.
Interactions: It is possible that concomitant use of other photosensitising
agents could increase the potential for photosensitivity reactions.
Visudyne precipitates in saline solutions. Should not be mixed with other
drugs in the same solution.
Adverse reactions: Undesirable effects in clinical trials or spontaneously
reported during post marketing surveillance include:
Ocular side effects:
Common effects: Abnormal vision (e.g. blurry, hazy, vision), or flashes of
light, decreased vision, visual field defect (e.g. grey or dark haloes, scotoma
and black spots). Severe vision decrease, equivalent of 4 lines or more, within
7 days after treatment was reported in 2.1% of the verteporfin treated patients
in the placebo-controlled ocular Phase III clinical studies and in less than 1%
of patients in uncontrolled clinical studies. The event occurred mainly in patients with occult only CNV lesions due to AMD. Partial recovery of vision was
observed in some patients.
Uncommon effects: Retinal detachment (non-rhegmatogenous), subretinal/retinal haemorrhage, vitreous haemorrhage.
Rare effects: Retinal or choroidal vessel non-perfusion, retinal pigment epithelial tear.
Injection site side effects:
Common effects: Pain, oedema, inflammation, extravasations.
Uncommon effects: Haemorrhage, discoloration, and hypersensitivity.
Rare effects: Blistering.
Systemic side effects:
Common effects: Infusion-related pain primarily presenting as back pain,
photosensitivity reaction, asthenia. Photosensitivity reactions occurred in
the form of sunburn following exposure to sunlight usually within 24 hours
of Visudyne infusion. Such reactions could be avoided by compliance with
photosensitivity protection instructions.
Uncommon effects: Hypertension, hypoesthesia, fever, nausea.
Rare effects: Vaso-vagal reactions and hypersensitivity reactions which on
rare occasions can be severe. General symptoms can include headache,
malaise, syncope, sweating, dizziness, rash, urticaria, pruritus, dyspnoea,
flushing and changes in blood pressure or heart rate.
Infusion related back pain and chest pain, which may radiate to other areas
including but not limited to pelvis, shoulder girdle or rib cage.
Packs: Glass vial containing 15 mg powder.
Prices: Country specific.
Note: Before prescribing, please read full prescribing information.
LUCENTIS
Note: Before prescribing, consult full prescribing information.
Presentation: Ranibizumab. Each vial contains 2.3 mg of ranibizumab in
0.23 mL solution.
Indications: Treatment of neovascular (wet) age-related macular degeneration (AMD). Treatment of visual impairment due to diabetic macular edema
(DME). Treatment of visual impairment due to macular edema secondary to
retinal vein occlusion (branch RVO or central RVO).
Dosage: The recommended dose is 0.5 mg (0.05 mL) given as a single intravitreal injection. Treatment is given monthly and continued until maximum
visual acuity is achieved, confirmed by stable visual acuity for three consecutive monthly assessments performed while on Lucentis treatment. Patients
should be monitored monthly for visual acuity. Treatment is resumed with
monthly injections when monitoring indicates a loss of visual acuity due to wet
AMD, DME or macular edema secondary to RVO and continued until stable
visual acuity is reached again for three consecutive monthly assessments.
The interval between two doses should not be shorter than 1 month. Lucentis and laser photocoagulation in DME or in branch RVO: Lucentis has been
used concomitantly with laser photocoagulation in clinical studies. When given on the same day, Lucentis should be administered at least 30 minutes after
laser photocoagulation. Lucentis can be administered in patients who have
received previous laser photocoagulation. Lucentis must be administered by
a qualified ophthalmologist using aseptic techniques. Broad-spectrum topical microbicide and anaesthetic should be administered prior to the injection.
The patient should be instructed to self-administer antimicrobial drops four
times daily for 3 days before and after each injection. Not recommended in
children and adolescents.
Contraindications: Hypersensitivity to ranibizumab or to any of the excipients, patients with active or suspected ocular or periocular infections, patients with active intraocular inflammation.
Precautions/Warnings: Intravitreous injections have been associated
with endophthalmitis, intraocular inflammation, rhegmatogenous retinal detachment, retinal tear and iatrogenic traumatic cataract. Therefore proper
aseptic injection techniques must be used. Patients should be monitored during the week following the injection to permit early treatment if an infection occurs. Transient increases in intraocular pressure (IOP) have been seen within
60 minutes of injection of Lucentis. Sustained IOP increases have also been
reported. Intraocular pressure and the perfusion of the optic nerve head must
be monitored and managed appropriately. There is a potential risk of arterial
thromboembolic events following intravitreal use of VEGF inhibitors. A numerically higher stroke rate was observed in patients treated with ranibizumab
0.5 mg compared to ranibizumab 0.3 mg or control, however, the differences
were not statistically significant. Patients with known risk factors for stroke, including history of prior stroke or transient ischemic attack should be carefully
evaluated by their physicians as to whether Lucentis treatment is appropriate
and the benefit outweighs the potential risk. As with all therapeutic proteins,
there is a potential for immunogenicity with Lucentis. Lucentis has not been
studied in patients with active systemic infections or in patients with concurrent eye conditions such as retinal detachment or macular hole. There
is limited experience with treatment of patients with prior episodes of RVO
and of patients with ischemic branch RVO (BRVO) and central RVO (CRVO).
In patients with RVO presenting with clinical signs of irreversible ischemic
visual function loss, treatment is not recommended. Should not be used
during pregnancy unless the expected benefit outweighs the potential risk to
the fetus. For women who wish to become pregnant and have been treated
with ranibizumab, it is recommended to wait at least 3 months after the last
dose of ranibizumab before conceiving a child; use of effective contraception recommended for women of child-bearing potential; breast-feeding not
recommended. Following treatment patients may develop transient visual
disturbances that may interfere with their ability to drive or use machines.
Patients should not drive or use machines as long as these symptoms persist.
Interactions: No formal interaction studies have been performed.
Adverse reactions: Very common adverse reactions are: intraocular
inflammation, vitritis, vitreous detachment, retinal hemorrhage, visual disturbance, eye pain, vitreous floaters, conjunctival hemorrhage, eye irritation, foreign body sensation in eyes, lacrimation increased, blepharitis, dry eye, ocular hyperemia, eye pruritus, intraocular pressure increased, nasopharyngitis,
headache, arthralgia. Common adverse reactions are: retinal degeneration, retinal disorder, retinal detachment, retinal tear, detachment of the retinal
pigment epithelium, retinal pigment epithelium tear, visual acuity reduced, vitreous hemorrhage, vitreous disorder, uveitis, iritis, iridocyclitis, cataract, cataract subcapsular, posterior capsule opacification, punctuate keratitis, corneal
abrasion, anterior chamber flare, vision blurred, injection site hemorrhage,
eye hemorrhage, conjunctivitis, conjunctivitis allergic, eye discharge, photopsia, photophobia, ocular discomfort, eyelid edema, eyelid pain, conjunctival
hyperemia, stroke, influenza, urinary tract infection*, anemia, anxiety, cough,
nausea, allergic reactions (rash, pruritus, urticaria, erythema). Uncommon
adverse reactions are: blindness, endophthalmitis, hypopyon, hyphema,
keratopathy, iris adhesions, corneal deposits, corneal edema, corneal striae,
injection site pain, injection site irritation, abnormal sensation in eye, eyelid
irritation. Serious adverse events related to intravitreal injections included
endophthalmitis, rhegmatogenous retinal detachment, retinal tear and iatrogenic traumatic cataract.
* observed only in the DME population
Packs and prices: Country specific.
Legal classification: Country specific.
Self-assessment test:
Amsler Grid16,17