Clinical trial NCT02103738: Canadian Treat and Extend Analysis Trial With Ranibizumab
Official title: Canadian Treat and Extend Analysis Trial With Ranibizumab
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: wetAMD
Keywords: Lucentis
Ranibizumab
Treat and Extend
wetAMD
Age related macular degeneration
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2014-04-04
Enrollment: 505
Sex: ALL
Minimum age (years): 50
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of male and female Canadian patients diagnosed with visual impairment due to wAMD and for whom Ranibizumab has been prescribed as their standard of care by the treating physician. Eligibility for Ranibizumab will be determined by the study physician according to the current prescribing information. A total of 580 patients will be enrolled from approximately 20 to 25 centers.

Brief summary: This is an observational study to will evaluate and compare two Ranibizumab treatment regimens (Standard of care) in patients with neovascular (wet) age-related macular degeneration (wAMD) aiming to achieve and to maintain a maximum visual function benefit. The results will be used to generate further recommendations on the timing of treatment administration for patients with neovascular (wet) age-related macular degeneration (wAMD). In this context, the study will use the anatomical imaging (for example, optical coherence tomography \[OCT\]) to evaluate wAMD disease activity impacted by the recurrence of disease instability and for decision making in the treatment decision algorithm.


Eligibility criteria: Inclusion Criteria:

* Infomed consent,
* Male and Female, 50 years of age or older
* Diagnosis of treatment-naive CNV secondary to age-related macular degeneration(AMD) in the study eye,
* BCVA score between 78 and 19 letters inclusive,

Exclusion Criteria:

* Patients with structural foveal damage in the study eye,
* Patients with confounding severe oculare diseases,
* Patients with suspicion of ( Polypoidal Choroidal Vasculapathy PCV) in the study eye,
* Patients with active or suspected or periocular infections in either eye or active intraocular inflammation in either eye,
* Patients who had previous subfoveal laser photocoagulation in the study eye or history of vitrectomy surgery in the study eye,
* Patients who had any prior treatment in the study eye, e.g., with Visudyne\*, Avastin\*, prior Ranibizumab treatment, Ozurdex\*, external radiation therapy, transpupillary thermotherapy (TTT), or any intravitreal injection,
* Patients with a known sensitivity to Ranibizumab or any component of its formulation,
* Patients who have used any investigational agent in the last 30 days,
* Concurrent participation in a clinical trial or within 30 days prior to enrollment,
* Patients having received systemic treatment with any other anti-vascular endothelial growth factor (VEGF) therapy ≤ 60 days prior to enrollment
* Patients with physical or mental disabilities that prevent accurate vision testing,
* Patients physically unable to tolerate intravenous fluorescein angiography,
* Pregnant or breastfeeding female patients,
* Any patient with recent history of new onset cardiac disease or thromboembolic central nervous system (CNS) event (within 12 months of Baseline Visit),
* Patients with any other condition which, in the opinion of the Investigator, would require treatment that would significantly impact the treatment assessments during this study.

Primary outcomes:
measure: Mean Change in Visual Acuity
timeFrame: Baseline to Month 12
Secondary outcomes:
measure: Proportion of patients with a gain of equal or more than 5, 10, and 15 letters between the 2 treatment arms.
timeFrame: Baseline to Month 12
measure: Proportion of patients with a gain of equal or more than 5, 10, and 15 letters between the 2 treatment arms.
timeFrame: Baseline to Month 24
measure: Proportion of patients with a loss of less than 5, 10, and 15 letters between the 2 treatment arms from baseline to Month 12 and from baseline to Month 24.
timeFrame: baseline to Month 12
measure: Proportion of patients with a loss of less than 5, 10, and 15 letters between the 2 treatment arms.
timeFrame: baseline to Month 24
measure: Mean change in BCVA ETDRS between the 2 treatment arms at Month 12 compared to Month 3.
timeFrame: Month 12 and Month 3
measure: Mean change in BCVA ETDRS between the 2 treatment arms.
timeFrame: Baseline to Month 24
measure: Number of injections performed in each treatment arms.
timeFrame: Baseline to Month 24
measure: Number of injections performed in each treatment arms.
timeFrame: Month 12 to Month 24
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Novartis Investigative Site
state: Alberta
city: Edmonton
country: Canada
facility: Novartis Investigative Site
state: Alberta
city: Moncton
country: Canada
facility: Novartis Investigative Site
state: New Brunswick
city: St Johns
country: Canada
facility: Novartis Investigative Site
state: Newfoundland and Labrador
city: St Johns
country: Canada
facility: Novartis Investigative Site
state: Newfoundland and Labrador
city: Brampton
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Hamilton
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: London
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Missisauga
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Ottawa
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Timmins
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Boisbriand
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Drummondville
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Ste-Foy
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Thetford Mines
country: Canada
facility: Novartis Investigative Site
state: Quebec
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Kertes PJ, Galic IJ, Greve M, Williams G, Baker J, Lahaie M, Sheidow T. Efficacy of a Treat-and-Extend Regimen With Ranibizumab in Patients With Neovascular Age-Related Macular Disease: A Randomized Clinical Trial. JAMA Ophthalmol. 2020 Mar 1;138(3):244-250. doi: 10.1001/jamaophthalmol.2019.5540.