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Ian A Pearce; Real-world outcomes of ranibizumab treatment in patients with retinal vein occlusion: the LUMINOUS™ study. Invest. Ophthalmol. Vis. Sci. 2016;57(12):5155.
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© ARVO (1962-2015); The Authors (2016-present)
LUMINOUS™ (NCT01318941) is an ongoing, 5-year, observational, non-interventional, open-label study designed to assess long-term safety, efficacy, treatment patterns, and health-related quality of life outcomes in over 30,000 patients treated with ranibizumab (RBZ), across all approved indications in routine clinical practice across 43 countries. We report the baseline characteristics of 2,254 retinal vein occlusion (RVO) patients enrolled prior to March 2015 and the 1-year outcomes of 880 RVO patients enrolled prior to March 2014.
Patients were treated as per the local label. Data were analyzed by prior treatment history of the primary treated eye: treatment naïve (T1), prior RBZ treated (T2) or previously received other ocular treatments (T3).
Of the 2,254 RVO patients, 1,272 had branch RVO (BRVO) and 982 had central RVO (CRVO). Overall, the mean age of BRVO/CRVO patients was 69.0/69.5 years with 50.6/41.9% females and 75.4/79.5% Caucasians. In BRVO/CRVO patients, the mean visual acuity (VA, letters) was 50.7/40.9, 58.7/48.7, and 49.4/37.4 and the mean central retinal thickness (CRT, µm) was 452/555, 335/394, and 441/517 in T1, T2, and T3; respectively (Table). The baseline comorbidities in BRVO/CRVO patients included hypertension (61.6/59.6%), lipidemia (34.4/31.0%), diabetes (17.1/22.2%), family history of coronary artery disease (16.0/14.3%), obesity (13.4/10.9%), prior myocardial infarction (4.5/4.8%), and stroke (3.9/3.5%). In total, 463 BRVO and 417 CRVO patients had the potential for 1-year follow-up. For BRVO/CRVO patients who completed 1 year, the mean VA change was 13.4/8.9, 2.4/-0.5, and 2.5/13.7 in T1, T2, and T3; respectively. Injection and visit frequency is given in the Figure. The rates of ocular and non-ocular serious adverse events were 0.5% and 3.8%, respectively.
The LUMINOUS™global ongoing study provides the largest dataset of real-world outcomes for the licensed RBZ indications. In both BRVO and CRVO, among treatment naïve patients, substantial improvement in VA was observed over 1 year with low mean number of RBZ injections. VA was either maintained or gained in prior treated patients. Prior RBZ treated patients had higher VA and lower CRT at baseline than treatment naïve patients and those treated with other ocular therapies. No new safety issues were reported.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.
Baseline characteristics and comorbidities
VA outcomes over 1 year
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