Prescribing information

 

Key efficacy data for LUCENTIS in the treatment of wet AMD.

 

Wet AMD patients have varying clinical needs1,2

Real-world Treat & Extend* intervals at Year 11,2†

Graph showing the interval between treatment required in real-world patients treated with ranibizumab or aflibercept Treat & Extend

Adapted from Arnold et al. 20151 and Barthelmes et al. 2018.2

 

Arnold et al. was an observational study from Australia and New Zealand (n=1,011 patients, 1,198 eyes). Patients with wet AMD received intravitreal anti-VEGF treatment, exclusively using T&E* regimens. Treatment undertaken in routine clinical practice was predominantly with ranibizumab. Main outcome measures included change in VA over 2 years, number of injections and number of visits.1

Barthelmes et al. was a database observational study that included 136 treatment-naïve eyes from 123 patients with wet AMD tracked by the Fight Retinal Blindness outcome registry. Patients completed 24 months of sole monotherapy with aflibercept treatment under a T&E* regimen. Main outcome measures were change in VA at 24 months and number of injections and visits during the study period.2

*Once maximum VA is achieved and/or there are no signs of disease activity.3

 

LUCENTIS T&E* delivered powerful efficacy over 2 years4–6

LUCENTIS T&E* is a customisable treatment regimen that can be tailored to meet patients’ clinical needs.3 For more information, visit the Dosing and administration page.

RIVAL study 2-year results: Mean change in BCVA from baseline and mean number of injections at Years 1 and 2 in wet AMD patients.4

 

Graph showing mean change in BCVA at year 1 and year 2 with LUCENTIS vs aflibercept in the RIVAL study

Adapted from Gillies et al. 2020.4

 

Primary endpoint: There was no statistical difference between LUCENTIS and aflibercept in the change of square root area of macular atrophy from baseline to Month 24.4

RIVAL was a randomised, partially masked, reading centre-controlled study of ranibizumab and aflibercept used following a T&E* regimen. A total of 278 patients with 1 treatment-naïve eye presenting with subfoveal CNV secondary to wet AMD were randomised to receive 3 monthly injections as a loading dose before entering the T&E* phase. The primary endpoint was mean change in area of macular atrophy in the study eye from baseline to Month 24. Key secondary end points were mean number of injections from baseline to Months 12 and 24 and mean change in VA from baseline to Months 12 and 24.4

*Once maximum VA is achieved and/or there are no signs of disease activity.3

LUCENTIS Treat & Extend* delivered clinically meaningful VA gains across numerous studies5–10

Mean change in BCVA from baseline at Year 16–10†

STUDY MEAN CHANGE IN BCVA

FROM BASELINE AT YEAR 1


(ETDRS letters)
Abedi et al. 2014 (n=120)6

Prospective cohort study**
+9.5
TREX-AMD 2015 (n=40)7

RCT
+10.5
LUCAS 2016 (n=187)8

RCT
+8.4
TREND 2017 (n=294)9

RCT
+6.6
CANTREAT 2018 (n=268)10

Randomised, open-label study
+8.4

Abedi et al. 20146

A prospective cohort study of 120 wet AMD patients with CNV evaluating 2-year visual outcomes of a Treat and Extend protocol of anti-VEGF therapy. Patients received 3 initial monthly ranibizumab injections (the approval process could delay the start of treatment with ranibizumab. To avoid this, bevacizumab†† was used for 33 patients (27.5%) as the first injection with subsequent ranibizumab treatments once approval was obtained). Monthly injections were continued until there was no CNV activity (subretinal/intraretinal fluid, loss of >5 letters or persistent/new retinal haemorrhage). In the presence of CNV activity, this interval was shortened by 2 weeks. Main outcome measures included the percentage of patients losing 15 letters and the mean change in VA after 12 months and 24 months.

 

TREX-AMD 20157

A 2-year, Phase IIIb, multicentre, randomised, controlled study (n=60) in treatment-naïve wet AMD patients. Patients were randomised to receive intravitreal injections of ranibizumab 0.5 mg monthly (n=20) or according to a Treat and Extend (TREX) protocol (n=40). The primary endpoint was mean ETDRS BCVA change from baseline.

 

LUCAS (Berg) 20168

A 2-year, multicentre, randomised, non-inferiority trial (non-inferiority limit of 5 letters) comparing efficacy and safety of bevacizumab†† vs LUCENTIS when administered according to a Treat and Extend protocol for the treatment of wet AMD (n=441). Main outcome measure was mean change in VA at 2 years.

 

TREND 20179

A 12-month, prospective, randomised, multicentre study. The primary objective was to demonstrate that ranibizumab 0.5 mg Treat and Extend regimen (n=323) was non-inferior to ranibizumab 0.5 mg monthly regimen (n=327) according to change in BCVA from baseline to Month 12.

 

CANTREAT 201810

A 24-month, randomised, open-label, Canadian multicentre, non-inferiority study. Patients were randomised 1:1 to a monthly or Treat and Extend regimen (n=580). The primary endpoint was mean change in BCVA from baseline to Month 12.

*Once maximum VA is achieved and/or there are no signs of disease activity.3
Caution should always be taken when cross-comparing different clinical studies.
1,198 treatment-naïve eyes included. 49% of eyes received LUCENTIS monotherapy, 2% received bevacizumab†† monotherapy and 49% received combination therapy, of which 82.9% of injections were LUCENTIS.1
§Treatment regimen for aflibercept used in this study does not represent the current UK posology. For current UK aflibercept posology, please refer to the summary of product characteristics for aflibercept.
 **Mixed patient cohort who received ranibizumab or bevacizumab. Bevacizumab is not licensed for intra-ocular use in the UK.
†† Not licensed for ocular use.

Indications3

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; CNV, choroidal neovascularisation; ETDRS, Early Treatment Diabetic Retinopathy Study; RCT, Randomised controlled trial; T&E, Treat & Extend; VA, visual acuity; VEGF, vascular endothelial growth factor.

References

  1. Arnold JJ et al. Ophthalmology 2015;122(6):1212–1219.
  2. Barthelmes D et al. Retina 2018;38(1):20–28.
  3. LUCENTIS® (ranibizumab) Summary of Product Characteristics, July 2020.
  4. Gillies MC et al. Ophthalmology 2020;127(2):198–210.
  5. Amoaku WM et al. Eye 2015;29(6):721–731.
  6. Abedi F et al. Retina 2014;34(8):1531–1538.
  7. Wykoff CC et al. Ophthalmology 2015;122(12):2514–2522.
  8. Berg K et al. Ophthalmology 2016;123(1):51–59
  9. Silva R et al. Ophthalmology 2018;125(1):57–65.
  10. Kertes PJ et al. Ophthalmology 2019;126:841–848.
LUC20-C030e September 2020.
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