Prescribing information

 

   

Key guidelines and goals for treatment of wet AMD, DMO, CNV, PDR, RVO and ROP.

Wet AMD can develop quickly causing changes to central vision and sight loss.1,2 According to recommendations from the Royal College of Ophthalmologists2:

  • Patients presenting to community optometrists with suspected wet AMD should be referred directly and urgently to a specialist macular clinic
  • Treatment of confirmed wet AMD should start within 2 weeks of diagnosis, with timely review and re-treatment appointments as close as possible to the intended interval
  • Patients who have visual loss should have access to services which provide support and visual rehabilitation.

National Institute for Health and Care Excellence (NICE) recommendations for treating late AMD (wet active)3

 

Antiangiogenic therapies

Ranibizumab, within its marketing authorisation, is recommended as an option for the treatment of wet AMD if:

  • All of the following circumstances apply in the eye to be treated:
    •  The BCVA is between 6/12 and 6/96     
    • There is no permanent structural damage to the central fovea
    • The lesion size is less than or equal to 12 disc areas in greatest linear dimension
    • There is evidence of recent presumed disease progression (blood vessel growth, as indicated by fluorescein angiography, or recent visual acuity changes).

Aflibercept is recommended as an option for treating wet AMD only if:

  • It is used in accordance with the recommendations for ranibizumab in NICE technology appraisal guidance 155.

Switching and stopping angiogenic therapy

Consider switching anti-VEGF treatment for people with late AMD (wet active) if there are practical reasons for doing so, but be aware that clinical benefits are likely to be limited.

Consider observation without giving anti-VEGF treatment if disease appears stable.

Consider stopping anti-VEGF treatment if the eye develops severe, progressive loss of VA despite treatment as recommended above.

Stop anti-VEGF treatment if the eye develops late AMD (wet inactive) with no prospect of functional improvement.

National Institute for Health and Care Excellence (NICE) recommendations for DMO4–6

 

Ranibizumab is recommended as an option for treating visual impairment due to DMO only if:

  • The eye has a central retinal thickness of 400 micrometres or more at the start of treatment.

Aflibercept is recommended as an option for treating visual impairment due to DMO only if:

  • The eye has a central retinal thickness of 400 micrometres or more at the start of treatment.

Dexamethasone intravitreal implant is recommended as an option for treating diabetic macular oedema only if:

  • The implant is to be used in an eye with an intraocular (pseudophakic) lens and
  • The DMO does not respond to non-corticosteroid treatment, or such treatment is unsuitable.

National Institute for Health and Care Excellence (NICE) guidelines for CNV7,8

 

Ranibizumab is recommended as an option for treating visual impairment due to choroidal neovascularisation secondary to pathological myopia.7

Aflibercept is recommended, within its marketing authorisation, as an option for treating visual impairment because of myopic choroidal neovascularisation in adults.8

The Royal College of Ophthalmologists guidelines for proliferative diabetic retinopathy (2012)9

 

Full laser treatment is indicated for retinal new vessels. Wherever possible, laser treatment should be delivered the same day or should be arranged within 2 weeks of diagnosis of high risk PDR.9

National Institute for Health and Care Excellence (NICE) guidelines for retinal vein occlusion10–13

 

Ranibizumab is recommended as an option for treating visual impairment caused by macular oedema10:

  • Following central retinal vein occlusion or
  • Following branch retinal vein occlusion only if treatment with laser photocoagulation has not been beneficial, or when laser photocoagulation is not suitable because of the extent of macular haemorrhage.

Aflibercept is recommended as an option for treating visual impairment caused by macular oedema secondary to central vein occlusion.11

Aflibercept is recommended as an option within its marketing authorisation for treating visual impairment in adults caused by macular oedema after branch retinal vein occlusion.12

Dexamethasone intravitreal implant is recommended as an option for the treatment of macular oedema following central retinal vein occlusion.13

Dexamethasone intravitreal implant is recommended as an option for the treatment of macular oedema following branch retinal vein occlusion when13:

  • Treatment with laser photocoagulation has not been beneficial, or
  • Treatment with laser photocoagulation is not considered suitable because of the extent of macular haemorrhage.

According to guidelines from the Royal College of Ophthalmologists and the Royal College of Paediatrics and Child Health (2008)14:

  • All babies less than 32 weeks gestational age (up to 31 weeks and 6 days) or less than 1,501 g birthweight should be screened for ROP
  • All babies less than 31 weeks gestational age (up to 30 weeks and 6 days) or less than 1,251 g birthweight must be screened for ROP.

Treatment should be undertaken if any of the following indications are reached14:

  • Zone I, any ROP with plus disease
  • Zone I, stage 3 without plus disease
  • Zone II, stage 3 with plus disease.

Treatment should be seriously considered if the following indication is reached14:

  • Zone II, stage 2 with plus disease.

Treatment within 48 hours is recommended as the target standard.14

 

Indications15

LUCENTIS 0.5 mg is indicated in adults for:

  • The treatment of neovascular (wet) age-related macular degeneration (AMD)
  • The treatment of visual impairment due to diabetic macular oedema (DMO)
  • The treatment of proliferative diabetic retinopathy (PDR)
  • The treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO)
  • The treatment of visual impairment due to choroidal neovascularisation (CNV).

LUCENTIS 0.2 mg is indicated in preterm infants for:

  • The treatment of retinopathy of prematurity (ROP) with zone I (stage 1+, 2+, 3 or 3+), zone II (stage 3+) or AP-ROP (aggressive posterior ROP) disease.

 

AMD, age-related macular degeneration; BCVA, best-corrected visual acuity; DMO, diabetic macular oedema; NICE, National Institute for Health and Care Excellence; ROP, retinopathy of prematurity; VA, visual acuity; VEGF, vascular endothelial growth factor.

References

  1. Royal National Institute of Blind People. Understanding age-related macular degeneration. Available at: https://www.rnib.org.uk/sites/default/files/Understanding_AMD_2019.pdf [Accessed July 2020].
  2. The College of Optometrists and The Royal College of Ophthalmologists. Commissioning better eye care. Age-related macular degeneration, version: 1. 2013. Available at: https://www.rcophth.ac.uk/wp-content/uploads/2014/12/AMD-guidance-25-11-13-2013_PROF_262.pdf [Accessed July 2020].
  3. NICE. Treating late age-related macular degeneration (wet active). Available at: https://pathways.nice.org.uk/pathways/age-related-macular-degeneration#path=view%3A/pathways/age-related-macular-degeneration/treating-late-age-related-macular-degeneration-wet-active.xml&content=view-index [Accessed July 2020].
  4. NICE. Ranibizumab for treating diabetic macular oedema [TA274]. Available at: https://www.nice.org.uk/guidance/ta274 [Accessed July 2020].
  5. NICE. Aflibercept for treating diabetic macular oedema [TA346]. Available at: https://www.nice.org.uk/guidance/ta346 [Accessed July 2020].
  6. NICE. Dexamethasone intravitreal implant for treating diabetic macular oedema [TA349]. Available at: https://www.nice.org.uk/guidance/ta349 [Accessed July 2020].
  7. NICE. Ranibizumab for treating choroidal neovascularisation associated with pathological myopia [TA298]. Available at: https://www.nice.org.uk/guidance/ta298 [Accessed July 2020].
  8. NICE. Aflibercept for treating choroidal neovascularisation [TA486]. Available at: https://www.nice.org.uk/guidance/ta486 [Accessed July 2020].
  9. The Royal College of Ophthalmologists. Diabetic retinopathy guidelines. July 2013. Available at: https://www.rcophth.ac.uk/wp-content/uploads/2014/12/2013-SCI-301-FINAL-DR-GUIDELINES-DEC-2012-updated-July-2013.pdf [Accessed July 2020].
  10. NICE. Ranibizumab for treating visual impairment caused by macular oedema secondary to retinal vein occlusion [TA283]. Available at: https://www.nice.org.uk/guidance/ta283 [Accessed July 2020].
  11. NICE. Aflibercept for treating visual impairment caused by macular oedema secondary to central retinal vein occlusion [TA305]. Available at: https://www.nice.org.uk/guidance/ta305 [Accessed July 2020].
  12. NICE. Aflibercept for treating visual impairment caused by macular oedema after branch retinal vein occlusion [TA409]. Available at: https://www.nice.org.uk/guidance/ta409 [Accessed July 2020].
  13. NICE. Dexamethasone intravitreal implant for the treatment of macular oedema secondary to retinal vein occlusion [TA229]. Available at: https://www.nice.org.uk/guidance/ta229 [Accessed July 2020].
  14. Royal College of Ophthalmologists and Royal College of Paediatrics and Child Health. UK retinopathy of prematurity guideline. 2008. Available at: https://www.rcophth.ac.uk/wp-content/uploads/2014/12/2008-SCI-021-Guidelines-Retinopathy-of-Prematurity.pdf [Accessed July 2020].
  15. LUCENTIS® (ranibizumab) Summary of Product Characteristics, July 2020.
LUC20-C030c September 2020.
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