Observe the Effectiveness and Safety of Ranibizumab in Real Life Setting (LUMINOUS)

• ClinicalTrials.gov Identifier: NCT01318941
• Recruitment Status: Completed
• First Posted: March 21, 2011
• Last Update Posted: May 23, 2016
• Sponsor: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

Tracking Information

• First Submitted Date: March 17, 2011
• First Posted Date: March 21, 2011
• Last Update Posted Date: May 23, 2016
• Study Start Date: March 2011
• Actual Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 13, 2015)

• Mean Visual Acuity (VA) and mean change in VA [ Time Frame: 3,6, and 12 months from the baseline visit, and annually thereafter ]
• Incidence rate, relationship and severity of treatment emergent ocular and non-ocular adverse events [ Time Frame: Defined time periods during study duration from FPFV until 30 days after LPLV ]
• Mean visual acuity at quarterly intervals for the primary treated eye set [ Time Frame: Quarterly intervals from baseline visit during study duration (5 years) ]

• Original Primary Outcome Measures (submitted: March 17, 2011): Mean Visual Acuity (VA) and mean change in VA [ Time Frame: 3,6, and 12 months from the baseline visit, and annually thereafter ]

Current Secondary Outcome Measures (submitted: February 13, 2015)

• Incidence rate of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: From the time the patient signed the informed consent until 30 days after study discontinuation ]
• Number of ranibizumab injections administered per patient, per eye, and per person-year [ Time Frame: annually ]
• "National Eye Institute Visual Functioning Questionnaire-25" change from baseline [ Time Frame: annually ]
• Overall number of ranibizumab injections, number of visits, time interval between injections, duration of treatment, number of re-treatment, and reasons for treatment termination [ Time Frame: Over time during study duration (5 years) ]
• Change from baseline in National Eye Institute Visual Function Questionnaire 25 composite and sub-scale scores [ Time Frame: Over time during study duration (5 years) ]

Original Secondary Outcome Measures (submitted: March 17, 2011)

• Incidence rate of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: From the time the patient signed the informed consent until 30 days after study discontinuation ]
• Number of ranibizumab injections administered per patient, per eye, and per person-year [ Time Frame: annually ]
• "National Eye Institute Visual Functioning Questionnaire-25" change from baseline [ Time Frame: annually ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Observe the Effectiveness and Safety of Ranibizumab in Real Life Setting
• Official Title: LUMINOUS: Study to Observe the Effectiveness and Safety of Ranibizumab Through Individualized Patient Treatment and Associated Outcomes
• Brief Summary: This study will describe the long-term safety and effectiveness, treatment patterns,and patient reported quality of life associated with ranibizumab treatment in routine clinical practice for all approved indication included in the local product label.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Outpatient ophthalmology Clinics

Condition

• Wet Age Related Macular Degeneration, Diabetic Macular Edema, Retinal Vein Occlusion
• Wet Age Related Macular Degeneration
• Diabetic Macular Edema
• Retinal Vein Occlusion

Intervention

• Drug: Ranibizumab
• Other: Ranibizumab

Study Groups/Cohorts

Ranibizumab

Interventions:

• Drug: Ranibizumab
• Other: Ranibizumab

Publications *

• Holz FG, Minnella AM, Tuli R, Yoganathan P, Parikh S, Hamilton R; LUMINOUS study group. Ranibizumab treatment patterns in prior ranibizumab-treated neovascular age-related macular degeneration patients: Real-world outcomes from the LUMINOUS study. PLoS One. 2020 Dec 30;15(12):e0244183. doi: 10.1371/journal.pone.0244183. eCollection 2020.
• Leys AM, Ramboer E, Favreau M, Denhaerynck K, MacDonald K, Abraham I, Brie H. Long-Term Ranibizumab Treatment in Neovascular Age-Related Macular Degeneration: A Belgian Subanalysis from the Global Real-World LUMINOUSTM Study. Clin Ophthalmol. 2020 Jun 2;14:1473-1481. doi: 10.2147/OPTH.S242547. eCollection 2020.
• Pearce I, Clemens A, Brent MH, Lu L, Gallego-Pinazo R, Minnella AM, Creuzot-Garcher C, Spital G, Sakamoto T, Dunger-Baldauf C, McAllister IL; all the LUMINOUS study investigators. Real-world outcomes with ranibizumab in branch retinal vein occlusion: The prospective, global, LUMINOUS study. PLoS One. 2020 Jun 18;15(6):e0234739. doi: 10.1371/journal.pone.0234739. eCollection 2020.
• Mitchell P, Sheidow TG, Farah ME, Mahmood S, Minnella AM, Eter N, Eldem B, Al-Dhibi H, Macfadden W, Parikh S, Dunger-Baldauf C, Mahgoub MM, Schmidt-Erfurth U; LUMINOUS study investigators. Effectiveness and safety of ranibizumab 0.5 mg in treatment-naive patients with diabetic macular edema: Results from the real-world global LUMINOUS study. PLoS One. 2020 Jun 3;15(6):e0233595. doi: 10.1371/journal.pone.0233595. eCollection 2020.
• Schmidt-Erfurth U, Chong V, Loewenstein A, Larsen M, Souied E, Schlingemann R, Eldem B, Mones J, Richard G, Bandello F; European Society of Retina Specialists. Guidelines for the management of neovascular age-related macular degeneration by the European Society of Retina Specialists (EURETINA). Br J Ophthalmol. 2014 Sep;98(9):1144-67. doi: 10.1136/bjophthalmol-2014-305702.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 20, 2016): 30490
• Original Estimated Enrollment (submitted: March 17, 2011): 30000
• Actual Study Completion Date: April 2016
• Actual Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Adult patients, within age limits as defined by local regulations and local product label, who have previously been treated with, who are currently being treated with or initiating treatment with ranibizumab for any approved indication included in the local product label
• Willing and able to provide informed written consent personally or by legal proxy

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 in the 90 days prior to enrollment
• Other protocol-defined inclusion/exclusion criteria may apply

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Dominican Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Republic of, Malaysia, Mexico, Netherlands, Panama, Peru, Poland, Portugal, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Turkey, Ukraine, United Kingdom, Venezuela

Administrative Information

• NCT Number: NCT01318941
• Other Study ID Numbers: CRFB002A2406
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Novartis ( Novartis Pharmaceuticals )
• Original Responsible Party: External Affairs, Novartis Pharmaceuticals
• Current Study Sponsor: Novartis Pharmaceuticals
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Novartis Pharmaceuticals; Novartis Pharmaceuticals

• PRS Account: Novartis
• Verification Date: May 2016