An observational study in Wet Age-related Macular Degeneration, sponsored by Bayer. Completed at 1 site in Switzerland. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2023-06-05.
Sponsored by Bayer · Observational
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Among 30 studies in Macular Degeneration by Bayer — none open to participants now, 1 under way, none of them phase 3. Macular Degeneration · Bayer.
Among the 30 studies in Macular Degeneration by Bayer, this one is the 14th largest by enrollment of the 20 observational ones that give a count, is the only one that started in 2017, is one of 20 observational ones, and was the 20th registered.
1,459 studies on the registry are indexed under Macular Degeneration; 236 are open to participants now.
Browse Macular Degeneration studies →None of the 30 studies in Macular Degeneration by Bayer is open now. The open studies under Macular Degeneration, anywhere →
Of the 165 Macular Degeneration studies recruiting now, 116 (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: 55 Years and older · all sexes · no healthy volunteers.
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30 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 163 is above the median of 110 across 409 observational studies indexed under Macular Degeneration.
Median enrollment 296 across the 10 interventional studies, 680 across the 20 observational. Of the 29 that completed or were terminated, 10 (34%) have results posted.
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Bayer is the lead sponsor of 1,674 studies on the registry; 51 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 132 (62%) have results posted.
1 of the studies in Macular Degeneration by Bayer that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06929143BayerA Study to Learn More About the Use of Aflibercept in Routine Medical Practice in Japanese Participants With Neovascular Age-related Macular Degeneration and Diabetic Macular Edema | 2027-07-30 |
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Among the 30 studies in Macular Degeneration by Bayer, from their registry updates:
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The purpose of this observational study lies in the analysis of a treat-and-extend injection scheme with intravitreal aflibercept (i.e. injection into the eye), as applied in routine practice in previously untreated patients diagnosed with wet age-related macular degeneration.
Data will be collected from the medical files retro- and prospectively. If patients are still under treatment at study initiation and have not yet completed 24 months of treatment with intravitreal aflibercept in a treat-and-extend regimen, data of the remaining observation period will be collected prospectively.
Treatment-naive wet age-related macular degeneration patients under routine intravitreal aflibercept treatment in a treat-and-extend scheme
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treatment-naive wet age-related macular degeneration patients under routine intravitreal aflibercept treatment in a treat-and-extend scheme
Drug: Aflibercept (Eylea, BAY86-5321)
Intravitreal aflibercept injections used in a routine "treat and extend" regimen, under which the intervals between the injections are extended if disease stability is maintained and no signs of worsening disease are observed on the injection day
Mean change from baseline in best-corrected visual acuity in Early Treatment Diabetic Retinopathy Study letters (ETDRS letters)
mean change in ETDRS letters
Time frame: Baseline and at 12 months
Mean change from baseline in best-corrected visual acuity (in Early Treatment Diabetic Retinopathy Study (ETDRS) letters)
mean change in ETDRS letters
Time frame: Baseline and at 24 months
Mean change in best-corrected visual acuity in relation to the number of injections administered
Numbers of injections will be predefined as categories and analyzed in relation to the BCVA changes
Time frame: Baseline and at 12 months; Baseline and at 24 months
Mean interval between injections
mean interval displayed in weeks or days
Time frame: At 12 and 24 months
Reasons for the interval length
morphology and / or BCVA /other
Time frame: At 12 and 24 months
Frequency of disease reactivation
Disease activity such as hemorrhage, PED, subretinal fluid, cystoid intraretinal fluid, RPE rip assessed at the investigator's discretion as: none / new or increasing / decreasing / stable
Time frame: Baseline and at 12 months; Baseline and at 24 months
Proportion of eyes gaining or losing ≥ 15 Early Treatment Diabetic Retinopathy Study letters compared to baseline
Proportion evaluated as percentage (%) of eyes
Time frame: Baseline and at 12 months; Baseline and at 24 months
Mean changes from baseline in central retinal thickness (CRT)
micro meter (µm)
Time frame: Baseline and at 3 months; Baseline and at 12 months; Baseline and 24 months
Changes from baseline in retinal fluid
intraretinal or subretinal fluid or pigment epithelial detachment (PED)
Time frame: Baseline and at 12 months; Baseline and at 24 months
Reasons for termination of therapy (including subsequent therapy at time of discontinuation)
Categorized into typical reasons for discontinuation such as e.g. death, lost to Follow-up, withdrawal of informed consent, change of treatment regimen, discontinuation of IVT-AFL treatment, interfering surgery or treatment, adverse event, other
Time frame: At 12 and 24 months
Severity of disease reactivation
Severity of disease reactivation assessed at the investigator's discretion as: no new disease activity / mild / severe
Time frame: Baseline and at 12 months; Baseline and at 24 months
Plan to share: No
Ran from Dec 2017 to primary completion in Nov 2018, 11 months.
Of 56 industry-sponsored observational studies under Macular Degeneration, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 69. This study's 11 months is below that.
Counting every sponsor, half of 162 studies reached it within 45 months; a quarter within 15 and three quarters within 77.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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