Prescribing information

 

Key clinical study and real-world efficacy data for LUCENTIS® in the treatment of wet AMD.

 

LUCENTIS delivers powerful efficacy over 2 years1

  • RIVAL is the 1st and only trial to compare LUCENTIS and aflibercept* in an identical Treat & Extend regimen in wAMD patients‡1
  • LUCENTIS Treat & Extend delivered clinically meaningful BCVA gains across numerous studies2–7

 

Lucentis shows similar mean BCVA gain vs aflibercept1

  • BCVA gain delivered in similar number of injections as aflibercept1

 

Mean change in BCVA from baseline and mean number of injections at Years 1 and 2 in wAMD patients§

 

LUCENTIS Treat & Extend delivered clinically meaningful VA gains across numerous studies2–7

Mean change in BCVA from baseline at Year 1‖3–7

STUDY MEAN CHANGE IN BCVA

FROM BASELINE AT YEAR 1


(ETDRS letters)
Abedi et al. 2014 (n=120)3

Prospective cohort study**
+9.5
TREX-AMD 2015 (n=40)4

RCT
+10.5
LUCAS 2016 (n=187)5

RCT
+8.4
TREND 2017 (n=294)6

RCT
+6.6
CANTREAT 2018 (n=268)7

Randomised, open-label study
+8.5

 

*Treatment regimen for aflibercept used in this study does not represent the current UK posology. For current UK aflibercept posology, please refer to the aflibercept SmPC.
Once maximum VA is achieved and/or there are no signs of disease activity.
The primary endpoint of RIVAL was mean change in area of geographic atrophy from baseline to Month 24. Mean BCVA change was a key secondary endpoint. Patients received 3 initial monthly injections in both treatment groups.1
§Mixed model analysis, adjusting for baseline BCVA.
Mean number of injections.
Caution should always be taken when cross-comparing different clinical studies.
 **Mixed patient cohort who received ranibizumab or bevacizumab. Bevacizumab is not licensed for intra-ocular use in the UK.

LUCENTIS delivers similar BCVA gains to aflibercept in the real world8

FRB provides the longest comparative data for LUCENTIS and aflibercept in real-world practice.*

After 3 years of treatment, the wAMD patients receiving LUCENTIS experienced a BCVA gain of +2.4. Those receiving aflibercept had a BCVA gain of +1.6, with the same median number of injections.8

 

Mean BCVA change from baseline at Year 38

 

Eyes in the present study received injections during 85% of their visits, suggesting that treatment was administered predominantly using a Treat & Extend§ regimen.

 

*The Fight Retinal Blindness (FRB) Web-based system forms the core structure for the Save Sight Registries database and interface.
Statistically and clinically not significant.
Median number of treatment.
§Once maximum visual acuity is achieved and/or there are no signs of disease activity.

RIVAL confirms that patients’ clinical needs vary1

  • RIVAL is the 1st and only trial to compare LUCENTIS and aflibercept* in an identical Treat & Extend regimen in wAMD patients‡1

 

Distribution of maximum injection interval achieved over 24 months for LUCENTIS and aflibercept§1

 

RIVAL is a randomised, partially masked, reading centre-controlled study of ranibizumab and aflibercept used following a Treat & Extend regimen.

*Treatment regimen for aflibercept used in this study does not represent the current UK posology. For current UK aflibercept posology, please refer to the aflibercept SmPC.
Once maximum VA is achieved and/or there are no signs of disease activity.
The primary endpoint of RIVAL was mean change in area of geographic atrophy from baseline to Month 24. Mean BCVA change was a key secondary endpoint. Patients received 3 initial monthly injections in both treatment groups.1
§Data shows proportion of patients who achieved each of the injection intervals at least once during the study.

Real-world evidence shows wAMD patients have varying clinical needs9,10

These data indicate clinical practice with a treat and extend regimen can achieve good visual outcomes whilst decreasing the frequency of treatments and clinic visits.9,10

 

Real-world Treat & Extend* intervals at Year 1†9,10

Graph showing the interval between treatment required in real-world patients treated with ranibizumab or aflibercept Treat & Extend at year 1

Adapted from Arnold et al. 20159 and Barthelmes et al. 2018.10

 

*Once maximum VA is achieved and/or there are no signs of disease activity.
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
§Not licensed for ocular use.

 

Study information

A Phase 4, randomised, partially masked, multicentre study in which patients were randomised 1:1 to receive either intravitreal injections of ranibizumab 0.5 mg or aflibercept 2.0 mg and were treated according to the same reading centre-guided Treat and Extend (T&E) regimen after 3 initial monthly injections. The primary endpoint of RIVAL was mean change in area of geographic atrophy from baseline to Month 24. Mean BCVA change was a key secondary endpoint.1

A prospective cohort study of 120 wet AMD patients with CNV evaluating 2-year visual outcomes of a T&E 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.3

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.4

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 T&E protocol for the treatment of wet AMD (n=441). Main outcome measure was mean change in VA at 2 years.5

A 12-month, prospective, randomised, multicentre study. The primary objective was to demonstrate that ranibizumab 0.5 mg T&E regimen (n=323) was non-inferior to ranibizumab 0.5 mg monthly regimen (n=327) according to change in BCVA from baseline to Month 12.6

A 24-month, randomised, open-label, Canadian multicentre, non-inferiority study. Patients were randomised 1:1 to a monthly or T&E regimen (n=580). The primary endpoint was mean change in BCVA from baseline to Month 12.7

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.9

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.10

 

*Not licensed for ocular use.
Once maximum VA is achieved and/or there are no signs of disease activity.

AMD, age-related macular degeneration; BCVA: Best corrected visual acuity; CNV, choroidal neovascularisation; ETDRS, Early Treatment Diabetic Retinopathy Study; T&E, Treat & Extend; RCT, randomised control trial; SmPC, Summary of Product Characteristics; VA, visual acuity; VEGF, vascular endothelial growth factor; wAMD, wet age-related macular degeneration.

References

  1. Gillies MC, et al. Ophthalmology 2020;127(2):198–210.
  2. Amoaku WM, et al. Eye 2015;29(6):721–731.
  3. Abedi F, et al. Retina 2014;34(8):1531–1538.
  4. Wykoff CC, et al. Ophthalmol Retina Jul–Aug 2017;1(4):314–321.
  5. Berg K, et al. Ophthalmology 2016;123(1):51–59.
  6. Silva R, et al. Ophthalmology 2018;125(1):57–65.
  7. Kertes PJ, et al. JAMA Ophthalmol 2020;138(3):244–250.
  8. Bhandari S, et al. Ophthalmology 2020;127(3):369–376.
  9. Arnold JJ, et al. Ophthalmology 2015;122(6):1212–1219.
  10. Barthelmes D, et al. Retina 2018;38(1):20–28.
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UK | September 2021 | 154663
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