2013b LUMINOUS baseline data

Report
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
PURPOSE:
RESULTS:
• 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
• As of April 2013, the LUMINOUS study had
successfully
recruited
over
10, 000 number
patientsofglobally.
Percentage
of patients
receiving
cumulative
injections to
month 12
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.
• Ranibizumab is approved in the UK for the treatment of neovascular (wet) agerelated 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
Table 1: Demographic characteristics of the first cohort of UK
patients with wAMD
Characteristics
Total; N=690
Age, (years), mean (SD)
• 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.
Range (years)
79.2 (8.26)
45-99
Age group, n (%)
• <75 years
184 (26.6)
• 75 to <85
318 (46.1)
Percentage of patients experiencing visual loss and gain at Month 12 (letters)
• >85+ years
188 (27.2)
Gender, Female/Male (%)
60.3/39.6
Race, n (%)
• Caucasian
666 (96.5)
• Black
3 (0.4)
• Asian
6 (0.9)
• Other
15 (2.2)
Percentage of patients
• 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 healthrelated 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).
N, total number of patients; n, number of patients within the group
• 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 2: Baseline ocular characteristics of the first cohort of UK patients with wAMD (Primary
Treated Eye)
Characteristics
Treatment Naive
Existing Ranibizumab
Total
(TN); N=304
(ER); N=383
N=690
Mean VA (+SD), approx. ETDRS
letters
VA categories
, nby
(%)
Mean visual acuity (letters) of study
and fellow eye
visit
• <24
• 24 to <39
• 39 to <54
• 54 to <74
• > 74
Mean IOP (+SD), mmHg
Mean CRT (+SD), µm*
• All machines
• Time Domain
• Spectral Domain
Here, we present the baseline characteristics of the first cohort of 690 UK wAMD
Lesion Type, n (%)
patients recruited from March 2011 to February 2012
• Predom Classic
METHODS:
The LUMINOUS prospective study design is presented in Figure 2:
• Others
• Missing
Lesion Size, n (%)
• < 1 DA
• > 1 DA
• Missing
PED, n (%)
PCV, n (%)
RAP, n (%)
54.6 (17.52)
11 (3.6%)
47 (15.5%)
68 (22.4%)
139(45.7%)
39 (12.8%)
16 (3.26)
n=100
315.3 (143.37)
293.4 (84.25)
323.5 (159.53)
56.3 (19.55)
23 (6.0%)
54 (14.1%)
65 (17.0%)
154 (40.2%)
87 (22.7%)
15.8 (3.00)
n=242
246.7 (88.23)
262.3 (96.26)
245.2 (87.52)
55.5 (18.80)
35 (5.1%)
101 (14.6%)
134 (19.4%)
293 (42.5%)
127 (18.4%)
15.9 (3.10)
n=344
266.7 (111.29)
280.2 (89.16)
264.5 (114.53)
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%)
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%)
176 (57.9%)
9 (3.0%)
15 (4.9%)
220 (57.4%)
13 (3.4%)
16 (4.2%)
397 (57.5%)
22 (3.2%)
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
CONCLUSIONS:
Patients
Inclusion 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
•
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.
References
1. Yu L et al. Biochem Biophys Res Commun 2011; 408 (2):276-81; 2. UK Lucentis SmPC, 2013
*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
Poster presented at The Royal College of Ophthalmologists Annual Congress 21-23 May 2013, Liverpool, UK

similar documents