1. Medicines
  2. Ophthalmology
  3. LUCENTIS® (ranibizumab)
  4. Efficacy
  5. Efficacy in DMO

Prescribing information

 

Efficacy in DMO

Key efficacy data for LUCENTIS in the treatment of visual impairment due to DMO.

LUCENTIS Treat & Extend* delivered real-world results comparable to those seen in clinical trials1,2

Princess Alexandra Hospital 2-year audit data: LUCENTIS T&E* in real-world UK practice compared with RETAIN1,2

Study VA gains 

at 24 months		 Number of injections 

at 24 months
RETAIN (n=125)2 6.5 

(mean)		 12.8 

(mean)
PAH (n=193)1 7 

(median†)		 9 

(median†)

Princess Alexandra Hospital was a retrospective systematic review of 193 patients (267 eyes) with DMO treated with LUCENTIS in a UK clinical setting. Data was collected from the Eye Clinic in Princess Alexandra Hospital, Harlow from 2014 to 2015. Patients received LUCENTIS monotherapy on a T&E* regimen. The primary objective was to determine the efficacy of the T&E* regimen and to compare the data with that of the RETAIN study.1

*Once maximum VA is achieved and/or there are no signs of disease activity.3
†PAH poster presented median data.2

LUCENTIS T&E* delivered rapid and sustained BCVA gains comparable to those achieved with PRN2

LUCENTIS T&E* is a personalised treatment regimen that enables you to treat patients at the maximum possible interval.3 For more information, visit the Dosing and administration page.

RETAIN study 2-year results: mean BCVA gain from baseline in patients treated with LUCENTIS® T&E* with/without laser vs PRN

Graph showing mean change in BCVA from baseline to month 24 in patients treated with LUCENTIS T&E with/without laser vs PRN

LUCENTIS T&E* reduced DMO patient visits by up to 46% over 24 months vs PRN.2

RETAIN was a 2-year, single-masked, multicentre, randomised controlled trial of 372 patients comparing 0.5 mg ranibizumab T&E* monotherapy and 0.5 mg ranibizumab + laser in T&E* regimens vs 0.5 mg ranibizumab PRN. The primary objective of the study was to demonstrate the non-inferiority of ranibizumab 0.5 mg T&E* as monotherapy or adjunctive to laser vs ranibizumab 0.5 mg PRN treatment and if successful, then to demonstrate superiority, based on mean average change in BCVA from baseline to Month 1 through Month 12. Both T&E regimens were non-inferior to PRN.2

*Once maximum VA is achieved and/or there are no signs of disease activity.3
‡p=0.9327 vs PRN.2
§p=0.1599 vs PRN.2

 

LUCENTIS delivered long-term efficacy, maintaining VA gains for up to 5 years4

5-year trial results from DRCR.net Protocol I: VA gains for patients treated with LUCENTIS + prompt or deferred laser4

Graph showing VA gains from baseline to week 260 in patients treated with LUCENTIS + prompt or deferred laser

DRCR.net Protocol I was a multicentre, 3-year randomised study of 691 patients (854 eyes) expanded to 5 years, comparing 0.5 mg ranibizumab or 4 mg triamcinolone combined with focal/grid laser to laser alone. From Year 3 only data from the ranibizumab plus prompt or deferred laser was reported, with 124 (97%) and 111 (92%) completing the 5-year visit, respectively. The two groups assigned to sham intravitreous injection combined with prompt focal/grid laser or intravitreous corticosteroids combined with prompt focal/grid laser were given the opportunity to receive ranibizumab and thus randomised group comparisons were no longer valid. In Year 1 patients assigned to ranibizumab received 4 initial monthly doses, visited monthly, and were treated until Protocol defined ‘treatment success’. Laser could also be administered as required by Protocol defined criteria. In Years 2–5, dependent on response, time between monitoring visits could be extended to a maximum of 16 weeks. The primary objective of the study was to compare changes in VA between arms at the 1-year visit. The formulation of triamcinolone used in the study is not available in the UK4. Triamcinolone is not licensed for intra-ocular use in the UK.

**p=0.09 vs deferred group from the model adjusting for baseline VA; p=0.15 adjusted for all potential confounders.4

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.

 

BCVA, best-corrected visual acuity; DMO, diabetic macular oedema; DRCR, Diabetic Retinopathy Clinical Research; ETDRS, Early Treatment Diabetic Retinopathy Study; PAH, Princess Alexandra Hospital; PRN, pro re nata; T&E, Treat & Extend; VA, visual acuity.

References

  1. Dorairaj E et al. Abstract presented at European Society of Cataract & Refractive Surgeons (ESCRS), 10–12 February 2017, Maastricht, The Netherlands.
  2. Prünte C et al. Br J Ophthalmol 2016;100(6):787–795.
  3. LUCENTIS® (ranibizumab) Summary of Product Characteristics, July 2020.
  4. Elman MJ et al. Ophthalmology 2015;122(2):375–381.
LUC20-C030f September 2020.
Ophthalmology
Article
×

Ask Speakers

×

Medical Information Request

Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at http://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]