Ranibizumab 10mg/ml, solution for intravitreal injection (Lucentis®)
Ranibizumab Use in Macular Oedema Secondary to Branch Retinal Vein Occlusion (241)
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A guideline is intended to assist healthcare professionals in the choice of disease-specific treatments.
Clinical judgement should be exercised on the applicability of any guideline, influenced by individual patient characteristics. Clinicians should be mindful of the potential for harmful polypharmacy and increased susceptibility to adverse drug reactions in patients with multiple morbidities or frailty.
If, after discussion with the patient or carer, there are good reasons for not following a guideline, it is good practice to record these and communicate them to others involved in the care of the patient.
The treatment of visual impairment due to macular oedema secondary to branch retinal vein occlusion (BRVO)
The treatment will be prescribed by doctors with a special interest in retinal disease and administered by either trained doctors or trained nurses.
Patients must fulfill ALL of the following criteria in the eye to be treated:
- Best Corrected Visual Acuity (BCVA) between 6/12 and 6/96.
- A mean central retinal subfield thickness measured using optical coherence tomography (OCT) of 250 micrometres or greater.
- No clinical evidence of spontaneous visual improvement over an initial 3 month period.
- Hypersensitivity to the active substance or to any of the excipients
- Patients with active or suspected ocular or periocular infections
- Patients with active severe intraocular inflammation
- Pregnancy
Ranibizumab 0.5mg is administered by intravitreal injection under aseptic conditions in accordance with existing national guidance.
Treatment is given monthly and continued until maximum visual acuity is achieved i.e. the patient's visual acuity is stable for three consecutive monthly assessments performed while on ranibizumab treatment. If there is no improvement in visual acuity over the course of the first three injections, continued treatment is not recommended.
The treatment can be given by a doctor or a trained practitioner. It should be noted that administration of the treatment by a trained practitioner is off-label but has been approved by the NHSGGC Governance Committee.
Pre and post administration:
Topical proxymetacaine and/or oxybuprocaine are instilled to the eye to be treated immediately before injection. 5% topical povidone-iodine solution is also instilled (either the Minims preparation or suitable special).
Patients will be required to be monitored to assess the effect of the treatment and identify adverse events. This will involve measuring visual acuity, OCT and clinical assessment. This will be required at monthly intervals when ranibizumab is being administered and thereafter at the clinician’s discretion.
Treatment will be stopped if:
- BCVA is stable for three consecutive monthly assessments performed while on ranibizumab treatment.
- BCVA>6/7.5 OR mean central retinal subfield thickness is less than 250 micrometres.
- If there is no improvement in visual acuity over the course of the first three injections.
- Evidence of deterioration of lesion morphology despite optimum treatment e.g. progressive increase in lesion or worsening of OCT indicators.
- hypersensitivity or contra-indication to ranibizumab
Most adverse events reported were transient, mild to moderate, and were attributed by the investigators to the injection procedure, rather than to the study drug. Serious adverse events related to the injection procedure occurred in less than 1% of intravitreal injections and included endophthalmitis and retinal detachment, and iatrogenic trauma.
Adherence to national guidance on intravitreal injections is required i.e. fully informed consent and injections being carried out in theatre or a dedicated clean room with adequate sterile technique by an ophthalmologist trained in intravitreal injections.
Systemic adverse events potentially related to systemic vascular endothelial growth factor (VEGF) inhibition were not significantly greater in treatment groups compared to sham injection and photo-dynamic therapy (PDT) in the studies analysed by the Scottish Medicines Consortium (SMC).
Please refer to Summary of Product Characteristics (SPC) for Lucentis® available at www.medicines.org.uk for full details of side effects and cautions for use.
Patients will be given instruction and information on how to contact the eye department if symptoms of concern occur i.e. visual loss or eye pain or increased redness of the eye. The same procedures adopted for intraocular surgery e.g. cataract surgery will be adopted.