An observational study in Macular Degeneration, sponsored by Bayer. Completed at 1 site in Spain. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2019-12-05.
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 17th largest by enrollment of the 20 observational ones that give a count, is one of 3 that started in 2018, is one of 20 observational ones, and was the 21st 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: 50 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. 3 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 116 is close to 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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There is a need to investigate the effectiveness of IVT aflibercept injection in routine clinical practice.
The aim of this study is to collect 12-month real-world clinical data from treatment-naïve nAMD patients who started first-line treatment with IVT aflibercept injection, according to the SmPC (Summary of Product Characteristics) and the SERV (Spanish Society of Retina and Vitreous) guidelines. The effectiveness of IVT aflibercept will be assessed by the changes in VA (Visual Acuity) and CRT (Central Retinal Thickness) during treatment.
The study will include data from adult patients newly diagnosed with nAMD who initiated and maintained anti-VEGF treatment with IVT aflibercept injection in 8 Spanish centers which treat AMD patients routinely.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patient data for whom treatment with IVT aflibercept injection was initiated as first-line treatment according to the SmPC and the SERV Guideline, in treatment-naive patients with newly diagnosed of nAMD in routine clinical practice.
Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
IVT(Intravitreal) aflibercept treatment in routine clinical practice.
Mean change in VA
The mean change in VA from baseline (i.e. just prior to the start of treatment) to 12 months in treatment-naïve patients with nAMD in routine clinical practice in Spain.
Time frame: From baseline to month 12
Mean change in VA
Time frame: From baseline to month 6
Proportion of patients gaining 15 or more letters
Time frame: At month 6 and 12
Mean change in CRT in µm (measured by OCT)
OCT:Optical Coherence Tomography
Time frame: From baseline to months 6 and 12
Presence/absence of SRF (subretinal fluid) by OCT (yes/no)
Time frame: At months 6 and 12
Presence/absence of IRF (intraretinal fluid) by OCT (yes/no)
Time frame: At months 6 and 12
Presence/absence of PED (pigment epithelium detachment) (measured by OCT)
Absence of PED: when the maximum distance between the outer border of the RPE and the inner border of the Bruch membrane is \<30 μm
Time frame: At months 6 and 12
Presence/absence of PED Height
Subfoveal and 500µm nasal and temporal; PED height defined as the distance between the outer border of the retinal pigment epithelium (RPE) and the inner border of the Bruch membrane
Time frame: At months 6 and 12
Presence/absence of PED type
Serous-vascularized or fibrovascular
Time frame: At months 6 and 12
Correlation of the mean gain in VA with the total number of injections administered
Time frame: 12 months
Mean number of IVT aflibercept injections per study eye
Time frame: The first 12 months
Mean number of monitoring visits per study eye
Visits only for diagnostic/follow-up purposes, but without injections
Time frame: The first 12 months
Mean number of combined visits per study eye
Visits for monitoring and injection
Time frame: The first 12 months
Mean number of OCT assessments per study eye
Time frame: The first 12 months
Ran from Feb 2018 to primary completion in Mar 2019, 12 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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