CAN-TREAT: Canadian Treat and Extend Analysis Trial With Ranibizumab

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT02103738

Collaborator

(none)

505

Enrollment

Locations

74.7

Actual Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
wetAMD	Other: 0.5 mg Ranibizumab intravitreal injections

Study Design

Study Type:

Observational

Actual Enrollment :

505 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Canadian Treat and Extend Analysis Trial With Ranibizumab

Actual Study Start Date :

May 8, 2013

Actual Primary Completion Date :

Jul 31, 2019

Actual Study Completion Date :

Jul 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Arm 1 (Monthly) 0.5 mg intravitreal injections of Ranibizumab monthly for the duration of the study.	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.
Arm 2 (Treat and Extend) Three consecutive months of 0.5 mg Ranibizumab intravitreal injections (Day 1, Month 1, and Month 2). Monthly injections will continue until evidence of disease stability is observed. Specifically, monthly treatment will continue until visual acuity is deemed stable as indicated by a gain in visual acuity of ≤ 3 ETDRS letters from the prior month, no clinical evidence of lesion growth, fluid or blood, and no intraretinal or subretinal fluid on OCT. When this is achieved, the intervals between each subsequent injection will be extended by 2 weeks (intervals of 6 weeks, 8 weeks, 10 weeks, to a maximum of 12 weeks) until clinical or diagnostic evidence of disease instability is observed based on OCT findings and/or BCVA ETDRS.	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.

Arm

Intervention/Treatment

Arm 1 (Monthly)

0.5 mg intravitreal injections of Ranibizumab monthly for the duration of the study.

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.

Arm 2 (Treat and Extend)

Three consecutive months of 0.5 mg Ranibizumab intravitreal injections (Day 1, Month 1, and Month 2). Monthly injections will continue until evidence of disease stability is observed. Specifically, monthly treatment will continue until visual acuity is deemed stable as indicated by a gain in visual acuity of ≤ 3 ETDRS letters from the prior month, no clinical evidence of lesion growth, fluid or blood, and no intraretinal or subretinal fluid on OCT. When this is achieved, the intervals between each subsequent injection will be extended by 2 weeks (intervals of 6 weeks, 8 weeks, 10 weeks, to a maximum of 12 weeks) until clinical or diagnostic evidence of disease instability is observed based on OCT findings and/or BCVA ETDRS.

Other: 0.5 mg Ranibizumab intravitreal injections

Outcome Measures

Primary Outcome Measures

Mean Change in Visual Acuity [Baseline to Month 12]
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.

Secondary Outcome Measures

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]
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]
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]
Proportion of patients with a loss of less than 5, 10, and 15 letters between the 2 treatment arms. [baseline to Month 24]
Mean change in BCVA ETDRS between the 2 treatment arms at Month 12 compared to Month 3. [Month 12 and Month 3]
Mean change in BCVA ETDRS between the 2 treatment arms. [Baseline to Month 24]
Number of injections performed in each treatment arms. [Baseline to Month 24]
Number of injections performed in each treatment arms. [Month 12 to Month 24]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Calgary	Alberta	Canada	T2H0C8
2	Novartis Investigative Site	Edmonton	Alberta	Canada	T5H 0X5
3	Novartis Investigative Site	Moncton	New Brunswick	Canada	E1C 4B7
4	Novartis Investigative Site	St Johns	Newfoundland and Labrador	Canada	A1A 4A5
5	Novartis Investigative Site	St Johns	Newfoundland and Labrador	Canada	A1B 1S1
6	Novartis Investigative Site	Brampton	Ontario	Canada	L6Y 0P6
7	Novartis Investigative Site	Hamilton	Ontario	Canada	L8G 5E4
8	Novartis Investigative Site	London	Ontario	Canada	N6A 4G5
9	Novartis Investigative Site	Missisauga	Ontario	Canada	L5L 1W8
10	Novartis Investigative Site	Ottawa	Ontario	Canada	K1H 8L6
11	Novartis Investigative Site	Timmins	Ontario	Canada	P4N 0A2
12	Novartis Investigative Site	Toronto	Ontario	Canada	M3C 0G9
13	Novartis Investigative Site	Toronto	Ontario	Canada	M4N 3M5
14	Novartis Investigative Site	Toronto	Ontario	Canada	M5C 2T2
15	Novartis Investigative Site	Toronto	Ontario	Canada	M5T 2S8
16	Novartis Investigative Site	Toronto	Ontario	Canada	M5V 1H6
17	Novartis Investigative Site	Boisbriand	Quebec	Canada	J7H 1S6
18	Novartis Investigative Site	Drummondville	Quebec	Canada	J2C 2C4
19	Novartis Investigative Site	Montreal	Quebec	Canada	H3Z 1P4
20	Novartis Investigative Site	Montreal	Quebec	Canada	H4P 2S4
21	Novartis Investigative Site	Sherbrooke	Quebec	Canada	J1J 2B8
22	Novartis Investigative Site	Sherbrooke	Quebec	Canada	J1J 2E8
23	Novartis Investigative Site	Ste-Foy	Quebec	Canada	G1V 1T6
24	Novartis Investigative Site	Thetford Mines	Quebec	Canada	G6G 2V2