Ranibizumab Use in Macular Oedema Secondary to Non-Ischaemic Central Retinal Vein Occlusion (15)

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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.

Medicine name

Ranibizumab 10mg/ml, solution for intravitreal injection (Lucentis ®)

Indication

The treatment of visual impairment due to macular oedema secondary to non-ischaemic central retinal vein occlusion (CRVO).

Prescriber details

The treatment can be given by an ophthalmologist 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.

Criteria for patient selection

A diagnosis of non-ischaemic CRVO will be confirmed by a consultant or specialty doctor specialising in medical retina disease.

Criteria for treatment:

  1. No iris or angle neovascularisation and there is optical coherence tomography (OCT) evidence of macular oedema
  2. Visual acuity is 6/96 or better
  3. If visual acuity is less than 6/96, the potential for significant improvement in visual acuity is minimal and the risk of ocular neovascularisation is high. However, eyes with VA< 6/96 may be offered treatment as some of these eyes may respond. The patients should be watched for retinal and iris neovascularisation.
  4. If visual acuity is better than 6/12, it is reasonable to observe the patient for spontaneous resolution as per the judgment of the treating ophthalmologist

Contra-indications

  • 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

Administration details

Ranibizumab 0.5mg is administered by intravitreal injection under aseptic conditions.

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.

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.

Monitoring response to treatment

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.

Stopping treatment

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

Side-effects/cautions

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.

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.

Monitoring - treatment safety

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.

Last reviewed: 16 March 2022

Next review: 31 March 2025

Author(s): David Gilmour

Version: 4

Author Email(s): [email protected]

Approved By: Medicines Utilisation Subcommittee of ADTC

Document Id: 15