Canadian Treat and Extend Analysis Trial With Ranibizumab

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

505 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-08

Study Completion Date

2019-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

CANadian Study in Patients With Wet AMD, Evaluating the Efficacy and Safety of Switching From Intravitreal Aflibercept to RanIbizumab

NCT02634970

WITHDRAWN PHASE4

Safety and Tolerability of Ranibizumab in Mono/Bilateral Wet Age Related Macular Degeneration (w-AMD) Patients in Eyes With BCVA<2/10 and/or 2nd Affected Eye

NCT01986907

Wet Age Related Macular Degeneration

COMPLETED PHASE4

Efficacy and Safety of Two Treatment Regimens of 0.5 mg Ranibizumab Intravitreal Injections Guided by Functional and/or Anatomical Criteria, in Patients With Neovascular Age-related Macular Degeneration

NCT01780935

Neovascular Age-related Macular Degeneration

COMPLETED PHASE3

Cytokine and Visual Outcome Variations in Eyes Receiving Ranibizumab

NCT03056092

UNKNOWN PHASE4

Comparison of Treatment Regimens Using Ranibizumab: Intensive (Resolution of Intra- and Sub-retinal Fluid) vs Relaxed (Resolution of Intra-retinal Fluid and/or Sub-retinal Fluid >200µm at the Foveal Centre)

NCT01972789

Subfoveal Choroidal Neovascularization CNV Secondary to Wet Age-related Macular Degeneration AMD

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

wetAMD

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1 (Monthly)

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

0.5 mg Ranibizumab intravitreal injections

Intervention Type OTHER

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.

0.5 mg Ranibizumab intravitreal injections

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No