PMID- 34326500
OWN - NLM
STAT- MEDLINE
DCOM- 20220726
LR  - 20221122
IS  - 1476-5454 (Electronic)
IS  - 0950-222X (Print)
IS  - 0950-222X (Linking)
VI  - 36
IP  - 8
DP  - 2022 Aug
TI  - Effectiveness and safety of ranibizumab in patients with central retinal vein 
      occlusion: results from the real-world, global, LUMINOUS study.
PG  - 1656-1661
LID - 10.1038/s41433-021-01702-y [doi]
AB  - OBJECTIVE: To evaluate the effectiveness, treatment patterns and long-term safety 
      of ranibizumab 0.5 mg in treatment-naive patients with central retinal vein 
      occlusion (CRVO) in a real-world setting. METHODS: LUMINOUS, a 5-year, global, 
      prospective, multicentre, multi-indication, observational, open-label study, 
      recruited treatment naive or prior treated patients who were treated as per the 
      local ranibizumab label. Here, we report the mean change in visual acuity (VA; 
      Early Treatment Diabetic Retinopathy Study [ETDRS] letters), treatment exposure 
      over year (Y) 1 and 5-year safety in treatment-naive CRVO patients. RESULTS: At 
      baseline, the mean age of treatment-naive CRVO patients (n = 327) was 68.9 years, 
      with a mean (Standard deviation [SD]) VA of 40.6 (23.9) letters. At Y1, patients 
      (n = 144) had a mean (SD) VA gain from baseline of 10.8 (19.66) letters, with a 
      mean (SD) of 5.4 (2.65) ranibizumab injections. Patients demonstrated mean (SD) 
      VA gains of 2.7 (19.35), 11.6 (20.56), 13.9 (18.08), 11.1 (18.46) and 8.2 (24.86) 
      letters with 1, 2-3, 4-5, 6-8 and >8 ranibizumab injections, respectively. Mean 
      (SD) VA gains at Y1 in patients receiving loading (67.4%) and no loading dose 
      (32.6%) was 11.9 (20.42) and 8.4 (17.99) letters, respectively. Over five years, 
      the incidence of ocular/non-ocular adverse events (AEs) and serious AEs was 
      11.3%/8.6% and 1.2%/6.7%, respectively. CONCLUSIONS: These results demonstrate 
      the effectiveness of ranibizumab in treatment-naive CRVO patients at Y1 with 
      clinically meaningful VA gains and no new safety findings over five years. These 
      findings may help inform routine practice and enable better clinical management 
      to achieve optimal visual outcomes.
CI  - (c) 2021. The Author(s).
FAU - Lotery, Andrew
AU  - Lotery A
AUID- ORCID: 0000-0001-5541-4305
AD  - Clinical and Experimental Sciences, Faculty of Medicine, University of 
      Southampton, Southampton, UK.
FAU - Clemens, Andreas
AU  - Clemens A
AUID- ORCID: 0000-0001-6192-1557
AD  - Novartis Pharma AG, Basel, Switzerland. andreas.clemens@novartis.com.
AD  - Department of Cardiology and Angiology I, Heart Center Freiburg University, 
      Faculty of Medicine, University of Freiburg, Freiburg, Germany. 
      andreas.clemens@novartis.com.
FAU - Tuli, Raman
AU  - Tuli R
AD  - Department of Ophthalmology, University of Ottawa, Ottawa, Canada.
FAU - Xu, Xun
AU  - Xu X
AD  - Department of Ophthalmology, Shanghai First People's Hospital Affiliated to 
      Shanghai Jiaotong University, Shanghai, China.
FAU - Shimura, Masahiko
AU  - Shimura M
AD  - Department of Ophthalmology, Tokyo Medical University Hachioji Medical Center, 
      Hachioji-shi, Tokyo-To, Japan.
FAU - Nardi, Marco
AU  - Nardi M
AD  - Ophthalmology Unit, University of Pisa, Pisa, Italy.
FAU - Ziemssen, Focke
AU  - Ziemssen F
AUID- ORCID: 0000-0002-3873-0581
AD  - Department for Ophthalmology, Eberhard Karl University Tubingen, Tubingen, 
      Germany.
FAU - Dunger-Baldauf, Cornelia
AU  - Dunger-Baldauf C
AD  - Novartis Pharma AG, Basel, Switzerland.
FAU - Tadayoni, Ramin
AU  - Tadayoni R
AD  - Universite de Paris, Ophthalmology Department, AP-HP, Lariboisiere, Saint Louis 
      and Fondation Rothschild Hospitals, Paris, France.
CN  - LUMINOUS study group
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20210729
PL  - England
TA  - Eye (Lond)
JT  - Eye (London, England)
JID - 8703986
RN  - 0 (Angiogenesis Inhibitors)
RN  - ZL1R02VT79 (Ranibizumab)
SB  - IM
MH  - Aged
MH  - Angiogenesis Inhibitors/adverse effects
MH  - Humans
MH  - Intravitreal Injections
MH  - Prospective Studies
MH  - *Ranibizumab/adverse effects
MH  - *Retinal Vein Occlusion/drug therapy
MH  - Tomography, Optical Coherence
MH  - Treatment Outcome
PMC - PMC9307792
COIS- AL: Consultant for Novartis and Allergan. AC: Shareholder and full-time employee 
      of Novartis Pharma AG. RT: Consultant for Roche; has received grants from 
      Novartis, Roche and Apellis. XX: Nothing to disclose. MS: Nothing to disclose. 
      MN: Consultant for Alcon and Santen; has lectured for Allergan; has performed 
      trials or received grants from Novartis, Bayer, Roche, Sensimed, Ivantis, 
      Formycon and Coronis GmbH. FZ: Consultant for Alimera, Allergan, Bayer, 
      Boheringer Ingelheim, MSD, Novartis, Novonordisk, Oxurion, Optos and Roche; has 
      lectured for Allergan, Bayer, CME Health, Novartis and ODOS. CD-B: Shareholder 
      and part-time employee of Novartis Pharma AG. RT: Consultant for Novartis, Roche, 
      Genentech, Bayer, Allergan, Oculis, Thea, Alcon, B + L, Zeiss, Moria and Cutting 
      Edge. The aforementioned disclosures for all authors do not alter our adherence 
      to journal policies on sharing data and materials.
EDAT- 2021/07/31 06:00
MHDA- 2022/07/27 06:00
PMCR- 2021/07/29
CRDT- 2021/07/30 06:36
PHST- 2020/12/14 00:00 [received]
PHST- 2021/07/15 00:00 [accepted]
PHST- 2021/07/13 00:00 [revised]
PHST- 2021/07/31 06:00 [pubmed]
PHST- 2022/07/27 06:00 [medline]
PHST- 2021/07/30 06:36 [entrez]
PHST- 2021/07/29 00:00 [pmc-release]
AID - 10.1038/s41433-021-01702-y [pii]
AID - 1702 [pii]
AID - 10.1038/s41433-021-01702-y [doi]
PST - ppublish
SO  - Eye (Lond). 2022 Aug;36(8):1656-1661. doi: 10.1038/s41433-021-01702-y. Epub 2021 
      Jul 29.