Canadian Treat and Extend Analysis Trial With Ranibizumab (CAN-TREAT)

Novartis

Status: Completed

Conditions: wetAMD

Treatments: Other: 0.5 mg Ranibizumab intravitreal injections

Study type: Observational

Funder types: Industry

Identifiers

NCT02103738

CRFB002ACA06

Details and patient eligibility

About

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.

Enrollment: 505 patients

Sex: All

Ages: 50 to 50 years old

Volunteers: No 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.

Trial design

505 participants in 2 patient groups

Arm 1 (Monthly)

Description:

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

Treatment:

Other: 0.5 mg Ranibizumab intravitreal injections

Arm 2 (Treat and Extend)

Description:

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.

Treatment:

Other: 0.5 mg Ranibizumab intravitreal injections