PURPOSE:

• Ranibizumab (Lucentis®) is a humanized monoclonal antibody Fab fragment, specifically designed for ocular use. It selectively binds to and inhibits multiple isoforms of vascular endothelial growth factor A (VEGF-A), with low systemic half-life (~2 hours)1

• Ranibizumab is approved in the UK for the treatment of neovascular (wet) age-related macular degeneration (wAMD), visual impairment due to diabetic macular oedema (DMO), and visual impairment due to macular oedema secondary to retinal vein occlusion (RVO) 2

• Although the efficacy and safety profile of ranibizumab (Lucentis®) has been well established in randomised controlled clinical trials, there is a need for long term safety and effectiveness data in the real world setting.

• The LUMINOUS prospective study is a 5-year, global, observational study designed to evaluate long-term safety (particularly the incidence of infrequent and serious adverse events), effectiveness, treatment patterns and health-related quality of life outcomes in patients treated in routine clinical practice with ranibizumab 0.5 mg according to the label approved in the participating countries

• The study aims to enroll 30,000 patients from approximately 500 sites in 36 countries worldwide from March 2011 to March 2015, with end of the study in March 2016 (Figure 1).

Here, we present the baseline characteristics of the first cohort of 690 UK wAMD patients recruited from March 2011 to February 2012

METHODS:The LUMINOUS prospective study design is presented in Figure 2:

PatientsInclusion criteria• Adult patients (≥18 years) who are currently being treated with (existing

ranibizumab, ER) or initiating treatment (treatment naive, TN) ranibizumab for any approved indication included in the local product label

• Patients who provided written informed consent

Exclusion criteria • Simultaneous participation in a study that includes administration of any

investigational drug or procedure• Systemic or ocular treatment with any VEGF inhibitor other than ranibizumab, 90

days prior to study enrolment• Contraindications listed on the ranibizumab Summary of Product Characteristics

CONCLUSIONS:• LUMINOUS is an on-going study, successfully enrolling patients worldwide. The

UK is the current major contributor to the global total.• The overall baseline characteristics of the first cohort of enrolled wAMD

patients from the UK should be representative of the scenario seen in routine clinical practice. Compared to pivotal studies e.g. ANCHOR, a higher percentage of patients were in the better visual strata. One fifth of all patients who had prior ranibizumab therapy before entering LUMINOUS had vision of 74L or better.

• Forthcoming data from LUMINOUS will provide a valuable source of real world data.

Baseline characteristics of the UK wet age-related macular degeneration (wAMD) cohort of the observational study

Christopher Brand1, Mohammed Musadiq2, Yit Yang3, Simon Taylor4, Richard Gale5, Christopher Brittain6, Robin Hamilton7 on behalf of the UK LUMINOUS Investigators*

1. Royal Hallamshire Hospital, Sheffield, UK; 2. University Hospital of North Staffordshire; 3. Wolverhampton Eye Infirmary, Wolverhampton, UK; 4. Royal Surrey County Hospital, Guildford UK; 5. York District Hospital, York, UK; 6. Novartis Pharmaceuticals UK; 7. Moorfields Eye Hospital, London, UK

References 1. Yu L et al. Biochem Biophys Res Commun 2011; 408 (2):276-81; 2. UK Lucentis SmPC, 2013

Percentage of patients receiving cumulative number of injections to month 12

Mean visual acuity (letters) of study and fellow eye by visit

Percentage of patients experiencing visual loss and gain at Month 12 (letters)

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RESULTS:

• As of April 2013, the LUMINOUS study had successfully recruited over 10, 000 patients globally. The UK is currently the highest global recruiter to the study with over 5600 patients recruited to the study. At the time of the first cohort baseline analyses, the UK was the second highest contributor of data, recruiting 690 of the 1877 wAMD patients included within the analyses. Table 1 shows the overall demographic characteristics for the UK patients.

• At enrolment into the study, 44.1% of wAMD patients were treatment naive (TN), 55.5% were existing ranibizumab patients (ER) and 0.4% had received other ocular treatments prior to baseline. 4.1% of patients received bilateral treatment at baseline. The ocular characteristics of the primary treated eye are shown in Table 2.

Table 1: Demographic characteristics of the first cohort of UK patients with wAMD

Characteristics Total; N=690

Age, (years), mean (SD) 79.2 (8.26)

Range (years) 45-99

Age group, n (%)

• <75 years 184 (26.6)

• 75 to <85 318 (46.1)

• >85+ years 188 (27.2)Gender, Female/Male (%) 60.3/39.6Race, n (%)

• Caucasian 666 (96.5)

• Black 3 (0.4)

• Asian 6 (0.9)

• Other 15 (2.2)N, total number of patients; n, number of patients within the group

Table 2: Baseline ocular characteristics of the first cohort of UK patients with wAMD (Primary Treated Eye)

Characteristics Treatment Naive(TN); N=304

Existing Ranibizumab (ER); N=383

TotalN=690

Mean VA (+SD), approx. ETDRS letters

54.6 (17.52) 56.3 (19.55) 55.5 (18.80)

VA categories , n (%)• <24• 24 to <39• 39 to <54• 54 to <74• > 74

11 (3.6%)47 (15.5%)68 (22.4%)139(45.7%)39 (12.8%)

23 (6.0%)54 (14.1%)65 (17.0%)

154 (40.2%)87 (22.7%)

35 (5.1%)101 (14.6%)134 (19.4%)293 (42.5%)127 (18.4%)

Mean IOP (+SD), mmHg 16 (3.26) 15.8 (3.00) 15.9 (3.10)Mean CRT (+SD), µm*• All machines• Time Domain• Spectral Domain

n=100315.3 (143.37)293.4 (84.25)

323.5 (159.53)

n=242246.7 (88.23)262.3 (96.26)245.2 (87.52)

n=344266.7 (111.29)280.2 (89.16)

264.5 (114.53)

Lesion Type, n (%)• Predom Classic• Others• Missing

131 (43.1%)171 (56.3%)

2 (0.7%)

108 (28.2%)270 (70.5%)

5 (1.3%)

239 (34.6%)443 (64.2%)

8 (1.2%)

Lesion Size, n (%)• < 1 DA• > 1 DA• Missing

118 (38.8%)184 (60.5%)

2 (0.7%)

126 (32.9%)256 (66.8%)

1 (0.3%)

245 (35.5%)441 (63.9%)

4 (0.6%)

PED, n (%) 176 (57.9%) 220 (57.4%) 397 (57.5%)PCV, n (%) 9 (3.0%) 13 (3.4%) 22 (3.2%)RAP, n (%) 15 (4.9%) 16 (4.2%) 31 (4.5%)

3 patients received prior ocular treatments other than ranibizumab, data not shown. * 344 patients had CRT measurements at baseline, 49 with Time Domain, 295 with Spectral Domain OCT. DA, disc area; CRT, central retinal thickness; ETDRS, early treatment diabetic retinopathy study; N, total number of patients; n, number of patients within the group; PED, Pigment Epithelium Detachment; PCV, Polypoidal Choroidal Vasculopathy; RAP, Retinal Angiomatomous Proliferation; SD, standard deviation; VA, visual acuity

Poster presented at The Royal College of Ophthalmologists Annual Congress 21-23 May 2013, Liverpool, UK

*UK Centres contributing data to the first cohort baseline analyses: Moorfields Eye Hospital; University Hospital of North Staffordshire; New Cross Hospital; Royal Surrey County Hospital; York District Hospital; James Paget University Hospital; Leicester Royal Infirmary; Manchester Royal Eye Hospital; Pinderfields Hospital; Royal Hallamshire Hospital; East Kent Hospitals University NHS Trust; Royal Bolton Hospital; University Hospital North Durham; Southend University Hospital NHS Foundation Trust; St James’s University Hospital; Heart of England NHS Foundation Trust, Hull and East Yorkshire Eye Hospital The LUMINOUS study is sponsored by Novartis Pharmaceuticals AG; Support for poster production courtesy of Novartis Pharmaceuticals UK Ltd