An observational study in Age-related Macular Degeneration, sponsored by Laurence Postelmans. Completed at 1 site in Belgium. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2022-03-08.
Sponsored by Laurence Postelmans · Observational
Among 36 studies in Macular Degeneration with a site in Belgium — 4 open to participants now, 6 under way, 4 of them phase 3. Macular Degeneration · Belgium.
Among the 36 studies in Macular Degeneration with a site in Belgium, this one is the 8th largest by enrollment of the 10 observational ones that give a count, is one of 4 that started in 2021, is one of 10 observational ones, and was the 29th registered.
1,459 studies on the registry are indexed under Macular Degeneration; 238 are open to participants now.
Browse Macular Degeneration studies →4 of the 36 studies in Macular Degeneration with a site in Belgium are open now. Recruiting first, the newest first:
AbbVie · Sites in Belgium, United States, Austria and 14 more countries
Ages 50+
Janssen Research & Development, LLC · Sites in Belgium, United States, Australia and 15 more countries
Ages 60+
Hoffmann-La Roche · Sites in Belgium, United States, Argentina and 12 more countries
Ages 50+
Universitaire Ziekenhuizen KU Leuven · Sites in Belgium
Ages 50–85
A study can be open while its sites in Belgium have not opened yet or have stopped. Only those recruiting at a site in Belgium →
Of the 166 Macular Degeneration studies recruiting now, 117 (70%) set no upper age limit and 5 (3%) stop at 75 or younger; 19 take children under 18; 35 take healthy volunteers.
This study: 50 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
36 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 7 · Phase 3 13 · Phase 4 3
First in 2006; this study’s year is marked. 4 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 36 is below the median of 110 across 409 observational studies indexed under Macular Degeneration.
Median enrollment 297 across the 26 interventional studies, 122 across the 10 observational. Of the 28 that completed or were terminated, 16 (57%) have results posted.
This tab as a report to print or save as PDF → With an account.
26 of 36 have an industry lead sponsor. The 10 most frequent:
Laurence Postelmans is the lead sponsor of 2 studies on the registry; none are open to participants now.
Laurence Postelmans has 1 study filed under Macular Degeneration — fewer than ten, so there is no comparison to draw.
2 of the studies in Macular Degeneration with a site in Belgium that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04657289Phase 3Hoffmann-La RocheA Study of the Efficacy, Safety, and Pharmacokinetics of a 36-Week Refill Regimen for the Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration (Velodrome) | 2027-02-04 |
| NCT04796545VisionCare, Inc.Post-market Clinical Investigation of the SING IMT System, Model NG SI IMT 3X in Patients With End-stage Age-related Macular Degeneration | 2027-05 |
Add all 2 to your calendar (.ics) → With an account.
Among the 36 studies in Macular Degeneration with a site in Belgium, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Age-related macular degeneration (AMD) is a leading cause of blindness in people over 50. Neovascular AMD, the most serious and severe form, is characterized by the appearance, spread and growth of subretinal new vessels. One of the major molecular mediators is vascular endothelial growth factor (VEGF).
Intra-vitreous (IVI) injection of an anti-VEGF can slow the progression of neovascular AMD and stabilize vision in the majority of cases. Aflibercept (Eylea®) is one of the anti-VEGF molecules approved in Belgium to treat neovascular AMD.
At the start of its use, aflibercept was first injected monthly and then according to the PRN "reactive" protocol (Pro Renata). Over time, a new treatment strategy has emerged: the "treat-and-extend" (T\&E). This is individualized patient care, the objective of which is to reduce the frequency of injections while ensuring inactivity of the disease. This begins with the loading dose, i.e. 3 injections given 4 weeks apart. Thereafter, the interval is lengthened in increments 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 IVI.
The efficacy and safety of aflibercept, when used in a proactive T\&E regimen, was demonstrated in the randomized controlled trial, ALTAIR. However, data on T\&E used in practice is still lacking. routine, and particularly the number of injections and treatment intervals over a minimum 24 month treatment period.
The aim of this retrospective study carried out at the CHU Brugmann is to determine the number of injections and the intervals necessary to have encouraging results in terms of visual acuity, over a treatment period of at least one year.
Patients of the CHU Brugmann Hospital, > 50 years old, diagnosed with neovascular age related macular degeneration, who have never received anti-VEGF treatment, and who started intra-vitreous injections of aflibercept between 01 January 2014 and November 30, 2019.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Data extraction from medical files
Injections number (first 24 months of treatment)
Number of injections during the first 24 months of treatment
Time frame: first 24 months of treatment
Injections interval
Last injection interval during the 2nd year of treatment, in weeks
Time frame: during the 2nd year of treatment
Injection number (up to 4 years of treatment)
Number of injections during the 1st, 2nd, 3rd and 4th year of treatment
Time frame: 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
Time frame: 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
Time frame: up to 4 years of treatment
Overall extension interval
Expected overall extension interval: by 1 week, 2 weeks, 3 weeks or 4 weeks
Time frame: up to 4 years of treatment
Covid 19 impact
Covid19 impact on the injection interval (visits cancelled due to lock-down, shortening/increase of the injection interval due to hospital internal emergency procedures)
Time frame: up to 4 years of treatment
Number of follow-up visits
Number of follow-up visits during each year of treatment up to 4 years
Time frame: up to 4 years of treatment
Visual acuity
Visual acuity at baseline, after 90 days and at the end of each year of treatment up to 4 years
Time frame: up to 4 years of treatment
Age
Age of the patient at baseline
Time frame: Baseline
Eye lesion type
Eye lesion type
Time frame: Baseline
Fluid
Presence or absence of intra-retinal fluid, subretinal fluid, detachment of the pigment epithelium at baseline, after 90 days and at the end of each year of treatment up to 4 years
Time frame: up to 4 years of treatment
Date of first symptoms
Date of first symptoms of neovascular AMD
Time frame: Baseline
Date of first injection
Date of first ranibizumab injection
Time frame: Baseline
Retinal thickness
Retinal thickness at baseline, after 90 days and at the end of each year of treatment up to 4 years
Time frame: up to 4 years of treatment
Treatment regimen
Has there been a change in treatment regimen after the first 12 months of treatment?
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: first 12 months of treatment
Reason for stopping treatment (first 12 months)
Reason for stopping treatment in the first 12 months
Time frame: first 12 months of treatment
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2021 to primary completion in Sep 2021, 5 months.
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This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Laurence Postelmans