wetAMDCAN-TREATNCT02103738
Canadian Treat and Extend Analysis Trial With Ranibizumab
An observational study of wetAMD, run by Novartis Pharmaceuticals at 24 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 50 to 50 years
- Conditions the study is for
- wetAMD
- What is being tested?
- 0.5 mg Ranibizumab intravitreal injections
- Type of treatment
- Injection or infusion
- How many people
- 505 participants
- Where
- 24 sitesCanada
- Study dates
- 8 May 2013to 31 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 50 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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,
Who cannot join
- 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,
Show all 15Show fewer
- 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 locations and contacts
24 sites in 1 country.
24 sites in 1 country
Canada24 sites
Novartis Investigative Site
Boisbriand, Quebec, J7H 1S6
Novartis Investigative Site
Brampton, Ontario, L6Y 0P6
Novartis Investigative Site
Calgary, Alberta, T2H0C8
Novartis Investigative Site
Drummondville, Quebec, J2C 2C4
Novartis Investigative Site
Edmonton, Alberta, T5H 0X5
Novartis Investigative Site
Hamilton, Ontario, L8G 5E4
Novartis Investigative Site
London, Ontario, N6A 4G5
Novartis Investigative Site
Missisauga, Ontario, L5L 1W8
Novartis Investigative Site
Moncton, New Brunswick, E1C 4B7
Novartis Investigative Site
Montreal, Quebec, H3Z 1P4
Novartis Investigative Site
Montreal, Quebec, H4P 2S4
Novartis Investigative Site
Ottawa, Ontario, K1H 8L6
Novartis Investigative Site
Sherbrooke, Quebec, J1J 2B8
Novartis Investigative Site
Sherbrooke, Quebec, J1J 2E8
Novartis Investigative Site
St. John's, Newfoundland and Labrador, A1A 4A5
Novartis Investigative Site
St. John's, Newfoundland and Labrador, A1B 1S1
Novartis Investigative Site
Ste-Foy, Quebec, G1V 1T6
Novartis Investigative Site
Thetford-Mines, Quebec, G6G 2V2
Novartis Investigative Site
Timmins, Ontario, P4N 0A2
Novartis Investigative Site
Toronto, Ontario, M3C 0G9
Novartis Investigative Site
Toronto, Ontario, M4N 3M5
Novartis Investigative Site
Toronto, Ontario, M5C 2T2
Novartis Investigative Site
Toronto, Ontario, M5T 2S8
Novartis Investigative Site
Toronto, Ontario, M5V 1H6
About this study
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.
- Conditions
- wetAMD
- Being tested
- 0.5 mg Ranibizumab intravitreal injections
- Keywords
- Lucentis, Ranibizumab, Treat and Extend, wetAMD, Age related macular degeneration
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5 mg Ranibizumab intravitreal injectionsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (Monthly) | 0.5 mg intravitreal injections of Ranibizumab monthly for the duration of the study. Receives: Other: 0.5 mg Ranibizumab intravitreal injections | |
| 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. Receives: Other: 0.5 mg Ranibizumab intravitreal injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Month 12
Secondary outcomes (8)
Proportion of patients with a gain of equal or more than 5, 10, and 15 letters between the 2 treatment arms.
Measured: 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.
Measured: 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.
Measured: baseline to Month 12
Proportion of patients with a loss of less than 5, 10, and 15 letters between the 2 treatment arms.
Measured: baseline to Month 24
Mean change in BCVA ETDRS between the 2 treatment arms at Month 12 compared to Month 3.
Measured: Month 12 and Month 3
Mean change in BCVA ETDRS between the 2 treatment arms.
Measured: Baseline to Month 24
Number of injections performed in each treatment arms.
Measured: Baseline to Month 24
Number of injections performed in each treatment arms.
Measured: Month 12 to Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study start8 May 2013
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for wetAMDStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 505 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02103738
- Sponsor's protocol ID
- CRFB002ACA06
- Acronym
- CAN-TREAT
- Status last verified
- Jun 2020
- First submitted
- 18 Feb 2014
- Last updated
- 5 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31917441
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canadian Treat and Extend Analysis Trial With Ranibizumab
- ClinicalTrials.gov ID
- NCT02103738
- Acronym / sponsor ID
- CAN-TREAT / CRFB002ACA06
- Conditions
- wetAMD
- Keywords
- Lucentis, Ranibizumab, Treat and Extend, wetAMD, Age related macular degeneration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 505 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 8 May 2013 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 4 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (Monthly) | – | Other: 0.5 mg Ranibizumab intravitreal injections0.5 mg intravitreal injections of Ranibizumab monthly for the duration of the study. |
| Arm 2 (Treat and Extend) | – | Other: 0.5 mg Ranibizumab intravitreal injectionsThree 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. |
Who may qualify
- Ages
- 50 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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,
Key exclusion criteria (15 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.5 mg Ranibizumab intravitreal injectionsAll 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. | Other | Arm 1 (Monthly), Arm 2 (Treat and Extend) |
Primary outcome
Mean Change in Visual Acuity
Time frame: 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.
8 secondary outcomes
Proportion of patients with a gain of equal or more than 5, 10, and 15 letters between the 2 treatment arms.
Time frame: 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.
Time frame: 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.
Time frame: baseline to Month 12
Proportion of patients with a loss of less than 5, 10, and 15 letters between the 2 treatment arms.
Time frame: baseline to Month 24
Mean change in BCVA ETDRS between the 2 treatment arms at Month 12 compared to Month 3.
Time frame: Month 12 and Month 3
Mean change in BCVA ETDRS between the 2 treatment arms.
Time frame: Baseline to Month 24
Number of injections performed in each treatment arms.
Time frame: Baseline to Month 24
Number of injections performed in each treatment arms.
Time frame: Month 12 to Month 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
- Derived from this study: PubMed 31917441Kertes 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.
Related trials for wetAMD
Not yet recruitingPhase 1/2
First in Human Study of BETA-TT8 in wetAge-related Macular Degeneration (wetAMD)
Neovascular (Wet) Age-Related Macular Degeneration
Active, not recruitingPhase 3
Pivotal 2 Study of RGX-314 Gene Therapy in Participants With nAMD
AMD, nAMD
Not yet recruitingPhase 2
Phase 2a Study to Evaluate the Efficacy and Safety of SCAI-005 Ophthalmic Solution in Subjects With Neovascular Age-related Macular Degeneration
wetAMD, Age Related Macular Degeneration
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of wetAMD, run by Novartis Pharmaceuticals at 24 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Visual Acuity (time frame: Baseline to Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02103738, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2020.