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  2. LUCENTIS® (ranibizumab) 0.2 mg dose: Retinopathy of prematurity (ROP)

Prescribing information

 

LUCENTIS® (ranibizumab) 0.2 mg dose: Retinopathy of prematurity (ROP)

   

LUCENTIS is the first anti-VEGF approved for the treatment of ROP in the EU3

Lucentis targets VEGF, which is thought to be the main driver of pathologic blood vessel growth that occurs in ROP.1,2

 

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.

 

LUCENTIS® offers a higher success rate‡ vs laser for the treatment of ROP2§

Image of graphs detailing the Phase III Rainbow Study treatment success rate

Image of Visisure Syringe

Many centres in the UK have been trained to administer LUCENTIS® injections to preterm infants.

If you would like to learn how your centre  can register to administer LUCENTIS® injections to preterm infants for the treatment of ROP*, please click the below button to see the required steps.

Click here to view the steps

 

*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.3

‡Treatment success, as measured by survival without active ROP, unfavourable structural outcomes or need for a different treatment modality at or before 24 weeks.2

§The statistical significance of the primary endpoint in the odds ratio scale was not met.2

After the follow-up phase (24 weeks), infants exited the study and became eligible to join the RAINBOW extension study in which long-term opthalmological and paediatric efficacy and safety will be studied to 5 years of age.

RAINBOW was a randomised, open-label, superiority trial to assess the efficacy and safety of intravitreal ranibizumab vs laser therapy for the treatment of ROP. Eligible infants had a birthweight less than 1,500 g and a diagnosis of bilateral ROP zone I stage 1+, 2+, 3 or 3+, or zone II stage 3+, or aggressive posterior ROP (AP-ROP). The primary objective was to investigate whether intravitreal ranibizumab 0.2 mg had superior efficacy to laser therapy in the treatment of ROP, as defined by survival without active ROP, unfavourable structural outcomes, or the need for a treatment modality other than that assigned, in both eyes, up to 24 weeks after starting investigational treatment.2

References

  1. Stahl A, et al. for the CARE-ROP Study Group. Comparing alternative ranibizumab dosages for safety and efficacy in retinopathy of prematurity: a randomized clinical trial. JAMA Pediatr. 2018; 172(3): 278–286.
  2. Stahl A, et al. Ranibizumab versus laser therapy for the treatment of very low birthweight infants with retinopathy of prematurity (RAINBOW): an open-label randomised controlled trial. Lancet. 2019; 394(10208): 1551–1559.
  3. LUCENTIS® Summary of Product Characteristics; July 2020.
UK | April 2021 | 108403
Ophthalmology
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Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at www.report.novartis.com
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at [email protected]