Canadian Treat and Extend Analysis Trial With Ranibizumab

wetAMD Clinical Trial

— CAN-TREAT  

Official title:

Canadian Treat and Extend Analysis Trial With Ranibizumab

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02103738
• Other study ID #: CRFB002ACA06
• Status: Completed
• Start date: May 8, 2013
• Est. completion date: July 31, 2019

Study information

• Verified date: June 2020
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 505
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• wetAMD

Intervention

Other:
• 0.5 mg Ranibizumab intravitreal injections
All eligible patients will initially be treated in a fixed loading phase, consisting of one intravitreal injection of Ranibizumab 0.5 mg per month for 3 consecutive months (Day 1, Month 1, and Month 2). After the loading phase, patients will be treated according to the treatment arm to which they have been assigned, either a continued once monthly dosing regimen, or an extended schedule of Ranibizumab intravitreal injections as described below. The planned duration of total treatment is 24 months.

Locations

Country	Name	City	State
Canada	Novartis Investigative Site	Boisbriand	Quebec
Canada	Novartis Investigative Site	Brampton	Ontario
Canada	Novartis Investigative Site	Calgary	Alberta
Canada	Novartis Investigative Site	Drummondville	Quebec
Canada	Novartis Investigative Site	Edmonton	Alberta
Canada	Novartis Investigative Site	Hamilton	Ontario
Canada	Novartis Investigative Site	London	Ontario
Canada	Novartis Investigative Site	Missisauga	Ontario
Canada	Novartis Investigative Site	Moncton	New Brunswick
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Ottawa	Ontario
Canada	Novartis Investigative Site	Sherbrooke	Quebec
Canada	Novartis Investigative Site	Sherbrooke	Quebec
Canada	Novartis Investigative Site	St Johns	Newfoundland and Labrador
Canada	Novartis Investigative Site	St Johns	Newfoundland and Labrador
Canada	Novartis Investigative Site	Ste-Foy	Quebec
Canada	Novartis Investigative Site	Thetford Mines	Quebec
Canada	Novartis Investigative Site	Timmins	Ontario
Canada	Novartis Investigative Site	Toronto	Ontario
Canada	Novartis Investigative Site	Toronto	Ontario
Canada	Novartis Investigative Site	Toronto	Ontario
Canada	Novartis Investigative Site	Toronto	Ontario
Canada	Novartis Investigative Site	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change in Visual Acuity	Visual Acuity (VA) will be assessed using best correction determined from protocol refraction during screening and every 3 months throughout the study; in the monthly regimen and during screening and at every visit thereafter throughout the study in the treat and extend regimen. VA measurements (number of letters correctly identified) will be performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like VA testing charts at an initial testing distance of 4 meters. This outcome measure will describe the difference in the VA mean changes between the two regimens from Baseline to Month 12.	Baseline to Month 12
Secondary	Proportion of patients with a gain of equal or more than 5, 10, and 15 letters between the 2 treatment arms.		Baseline to Month 12
Secondary	Proportion of patients with a gain of equal or more than 5, 10, and 15 letters between the 2 treatment arms.		Baseline to Month 24
Secondary	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.		baseline to Month 12
Secondary	Proportion of patients with a loss of less than 5, 10, and 15 letters between the 2 treatment arms.		baseline to Month 24
Secondary	Mean change in BCVA ETDRS between the 2 treatment arms at Month 12 compared to Month 3.		Month 12 and Month 3
Secondary	Mean change in BCVA ETDRS between the 2 treatment arms.		Baseline to Month 24
Secondary	Number of injections performed in each treatment arms.		Baseline to Month 24
Secondary	Number of injections performed in each treatment arms.		Month 12 to Month 24