Macular DegenerationNCT04988178
Analysis of naïve Patients With Age-related Macular Degeneration Neovascular Type and Treated With Ranibizumab (Lucentis®) in Treat-and-extend at the CHU Brugmann.
An observational study of Macular Degeneration, run by Brugmann University Hospital at 1 site in Belgium.
Trial summary
Age-related macular degeneration (AMD) is a leading cause of blindness in people over 50 years old. Neovascular AMD, the most severe form and the most severe is characterized by the appearance, spread and growth of subretinal neovessels. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- Data extraction from medical files
- How many people
- 34 participants
- Where
- 1 siteBelgium
- Study dates
- 13 Apr 2021to 22 Sep 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Naive patients with age-related macular degeneration, neovascular type, treated with ranibizumab (Lucentis®) in "treat-and-extend" at the CHU Brugmann Hospital.
Who may be able to join
- Patients> 50 years old diagnosed with neovascular age related macular degeneration,
- Patients who have never received anti-VEGF treatment,
- Patients who started intra-vitreous injections of ranibizumab between 01 January 2014 and November 30, 2019,
- Treatment by "treat-and-extend" directly after the loading dose of ranibizumab,
- Availability of the medical file reporting treatment with ranibizumab.
Who cannot join
- Participation in an interventional clinical study during treatment with ranibizumab,
- Patients suffering from ocular pathologies and having required surgery during the first 24 months of treatment with ranibizumab (for example advanced glaucoma or cataract).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Analysis of Naive Patients With Age-related Macular Degeneration Neovascular Type and Treated With Ranibizumab (Lucentis®) in Treat-and-extend at the CHU Brugmann.
Age-related macular degeneration (AMD) is a leading cause of blindness in people over 50 years old. Neovascular AMD, the most severe form and the most severe is characterized by the appearance, spread and growth of subretinal neovessels. One of the major molecular mediators is the endothelial growth factor vascular (VEGF).
Intra-vitreous (IVI) injection of an anti-VEGF may slow the progression of Neovascular AMD and stabilize vision in the majority of cases. Ranibizumab (Lucentis®) is one of the anti-VEGF molecules approved in Belgium to treat neovascular AMD.
Read more
At the start of its use, ranibizumab was first injected monthly and then according to the "reactive" protocol. Over time, a new strategy of treatment was born: the "treat-and-extend" (T\&E). This is 'made to measure' protocol for each patient aiming to reduce the frequency of injections while guaranteeing inactivity of the disease. It starts with the loading dose, i.e. 3 injections given 4 weeks apart. Subsequently, the interval is lengthened by slices of 1 or 2 weeks provided that the visual and anatomical results remain stable. In the event of deterioration, the interval is shortened while keeping a minimum of 4 weeks between each IIV.
The efficacy and safety of ranibizumab, when used in a proactive regimen of T\&E, has been shown in the CANTREAT randomized controlled trial. However, there is a lack of more data on T\&E used in current practice, and particularly on the number of injections and treatment intervals over a minimum treatment period of 24 months.
The aim of this retrospective study carried out at the CHU Brugmann Hospital is to determine the number of injections and the intervals necessary to have encouraging results in visual acuity over a treatment period of at least two years.
- Conditions
- Macular Degeneration
- Being tested
- Data extraction from medical files
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data extraction from medical filesOther
Data extraction from medical files
What is being measured
The primary outcome is the main question the study is designed to answer.
Injections number (first 24 months of treatment)
Number of injections during the first 24 months of treatment
Measured: first 24 months of treatment
Injections interval
Last injection interval during the 2nd year of treatment, in weeks
Measured: during the 2nd year of treatment
Secondary outcomes (24)
Injection number (up to 4 years of treatment)
Number of injections during the 1st, 2nd, 3rd and 4th year of treatment
Measured: up to 4 years of treatment
Injections interval (up to 4 years of treatment)
Last injection interval during the 1st, 2nd, 3rd and 4th year of treatment (if applicable), in weeks
Measured: up to 4 years of treatment
Most stable injection interval
Most stable injection interval during the 2nd, 3rd and 4th year of treatment (if applicable), in weeks
Measured: up to 4 years of treatment
Overall extension interval
Expected overall extension interval: by 1 week, 2 weeks, 3 weeks or 4 weeks
Measured: up to 4 years of treatment
Covid 19 impact
Impact of Covid-19 on the injection interval
Measured: up to 4 years of treatment
Number of follow-up visits
Number of follow-up visits during each year of treatment
Measured: up to 4 years of treatment
Visual acuity
Visual acuity at baseline, after 90 days and at the end of each year of treatment in the study
Measured: up to 4 years of treatment
Age
Age of the patient at baseline
Measured: Baseline
Eye lesion type
Eye lesion type
Measured: Baseline
Fluid
Presence or absence of intra-retinal fluid, subretinal fluid, detachment of the pigment epithelium
Measured: Baseline
Fluid
Presence or absence of intra-retinal fluid, subretinal fluid, detachment of the pigment epithelium
Measured: 90 days after baseline
Fluid
Presence or absence of intra-retinal fluid, subretinal fluid, detachment of the pigment epithelium
Measured: once a year up to 4 years of treatment
Date of first symptoms
Date of first symptoms of neovascular AMD
Measured: Baseline
Date of first injection
Date of first ranibizumab injection
Measured: Baseline
Retinal thickness
Retinal thickness at baseline, after 90 days and at the end of each year of treatment
Measured: up to 4 years of treatment
Treatment regimen
Has there been a change in treatment regimen after the first 12 months of treatment?
Measured: first 12 months of treatment]
Number of patients stopping treatment (12-24 months)
Number of patients stopping treatment between 12 and 24 months of treatment
Measured: between 12 and 24 months of treatment
Reason for stopping treatment (12-24 months)
Reason for stopping treatment between 12 and 24 months of treatment
Measured: between 12 and 24 months of treatment
Number of patients stopping treatment (24-36 months)
Number of patients stopping treatment between 24 and 36 months of treatment
Measured: between 24 and 36 months of treatment
Reason for stopping treatment (24-36 months)
Reason for stopping treatment between 24 and 36 months of treatment
Measured: between 24 and 36 months of treatment
Number of patients stopping treatment (36-48 months)
Number of patients stopping treatment between 36 and 48 months of treatment
Measured: between 36 and 48 months of treatment
Reason for stopping treatment (36-48 months)
Reason for stopping treatment between 36 and 48 months of treatment
Measured: between 36 and 48 months of treatment
Number of patients stopping treatment (first 12 months)
Number of patients who stopped treatment in the first 12 months
Measured: First 12 months of treatment
Reason for stopping treatment (first 12 months)
Reason for stopping treatment in the first 12 months
Measured: First 12 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start13 Apr 2021
- Primary completion22 Sep 2021
- Study completion22 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular DegenerationStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laurence Postelmans, Brugmann University Hospital
- Investigators
- Laurence Postelmans, Study director, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04988178
- Sponsor's protocol ID
- CHUB- KIERKOWICZ
- Status last verified
- Mar 2022
- First submitted
- 10 May 2021
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Naive Patients With Age-related Macular Degeneration Neovascular Type and Treated With Ranibizumab (Lucentis®) in Treat-and-extend at the CHU Brugmann.
- ClinicalTrials.gov ID
- NCT04988178
- Acronym / sponsor ID
- CHUB- KIERKOWICZ
- Conditions
- Macular Degeneration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- 13 Apr 2021 (actual)
- Primary completion
- 22 Sep 2021 (actual)
- Study completion
- 22 Sep 2021 (actual)
- First posted
- 3 Aug 2021 (actual)
- 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.
Age-related macular degeneration (AMD) is a leading cause of blindness in people over 50 years old. Neovascular AMD, the most severe form and the most severe is characterized by the appearance, spread and growth of subretinal neovessels. One of the major molecular mediators is the endothelial growth factor vascular (VEGF).
Intra-vitreous (IVI) injection of an anti-VEGF may slow the progression of Neovascular AMD and stabilize vision in the majority of cases. Ranibizumab (Lucentis®) is one of the anti-VEGF molecules approved in Belgium to treat neovascular AMD.
At the start of its use, ranibizumab was first injected monthly and then according to the "reactive" protocol. Over time, a new strategy of treatment was born: the "treat-and-extend" (T\&E). This is 'made to measure' protocol for each patient aiming to reduce the frequency of injections while guaranteeing inactivity of the disease. It starts with the loading dose, i.e. 3 injections given 4 weeks apart. Subsequently, the interval is lengthened by slices of 1 or 2 weeks provided that the visual and anatomical results remain stable. In the event of deterioration, the interval is shortened while keeping a minimum of 4 weeks between each IIV.
The efficacy and safety of ranibizumab, when used in a proactive regimen of T\&E, has been shown in the CANTREAT randomized controlled trial. However, there is a lack of more data on T\&E used in current practice, and particularly on the number of injections and treatment intervals over a minimum treatment period of 24 months.
The aim of this retrospective study carried out at the CHU Brugmann Hospital is to determine the number of injections and the intervals necessary to have encouraging results in visual acuity over a treatment period of at least two years.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Naive patients with age-related macular degeneration, neovascular type, treated with ranibizumab (Lucentis®) in "treat-and-extend" at the CHU Brugmann Hospital.
Key inclusion criteria (5 listed)
- Patients> 50 years old diagnosed with neovascular age related macular degeneration,
- Patients who have never received anti-VEGF treatment,
- Patients who started intra-vitreous injections of ranibizumab between 01 January 2014 and November 30, 2019,
- Treatment by "treat-and-extend" directly after the loading dose of ranibizumab,
- Availability of the medical file reporting treatment with ranibizumab.
Key exclusion criteria (2 listed)
- Participation in an interventional clinical study during treatment with ranibizumab,
- Patients suffering from ocular pathologies and having required surgery during the first 24 months of treatment with ranibizumab (for example advanced glaucoma or cataract).
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 |
|---|---|---|
| Data extraction from medical filesData extraction from medical files | Other | – |
Primary outcome
Injections number (first 24 months of treatment)
Time frame: first 24 months of treatment
Number of injections during the first 24 months of treatment
Injections interval
Time frame: during the 2nd year of treatment
Last injection interval during the 2nd year of treatment, in weeks
24 secondary outcomes
Injection number (up to 4 years of treatment)
Time frame: up to 4 years of treatment
Injections interval (up to 4 years of treatment)
Time frame: up to 4 years of treatment
Most stable injection interval
Time frame: up to 4 years of treatment
Overall extension interval
Time frame: up to 4 years of treatment
Covid 19 impact
Time frame: up to 4 years of treatment
Number of follow-up visits
Time frame: up to 4 years of treatment
Visual acuity
Time frame: up to 4 years of treatment
Age
Time frame: Baseline
Eye lesion type
Time frame: Baseline
Fluid
Time frame: Baseline
Fluid
Time frame: 90 days after baseline
Fluid
Time frame: once a year up to 4 years of treatment
Date of first symptoms
Time frame: Baseline
Date of first injection
Time frame: Baseline
Retinal thickness
Time frame: up to 4 years of treatment
Treatment regimen
Time frame: first 12 months of treatment]
Number of patients stopping treatment (12-24 months)
Time frame: between 12 and 24 months of treatment
Reason for stopping treatment (12-24 months)
Time frame: between 12 and 24 months of treatment
Number of patients stopping treatment (24-36 months)
Time frame: between 24 and 36 months of treatment
Reason for stopping treatment (24-36 months)
Time frame: between 24 and 36 months of treatment
Number of patients stopping treatment (36-48 months)
Time frame: between 36 and 48 months of treatment
Reason for stopping treatment (36-48 months)
Time frame: between 36 and 48 months of treatment
Number of patients stopping treatment (first 12 months)
Time frame: First 12 months of treatment
Reason for stopping treatment (first 12 months)
Time frame: First 12 months of treatment
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 21 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Laurence Postelmans study director
CHU Brugmann
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Macular Degeneration, run by Brugmann University Hospital at 1 site in Belgium.
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 5 inclusion and 2 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 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Injections number (first 24 months of treatment) (time frame: first 24 months of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Mar 2022.