An observational study in Macular Degeneration, sponsored by Bayer. Completed at 4 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-25.
Sponsored by Bayer · Observational
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
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 11th 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 22nd 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: 18 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.
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 643 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.
This tab as a report to print or save as PDF → With an account.
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 |
Add it to your calendar (.ics) → With an account.
Among the 30 studies in Macular Degeneration by Bayer, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The main objectives of this observational cohort study are to describe the use of intravitreal aflibercept and to describe follow-up as well as treatment patterns in patients with wAMD or DME in routine clinical practice in Latin America for a study population of treatment naive patients and those who have received prior therapy (anti-VEGF injections, laser, steroids, etc.) and are being switched to intravitreal aflibercept injection.
The study population will consist of patients with wAMD or DME treated with intravitreal aflibercept. If both eyes are eligible, data from both eyes will be captured, but only one eye will be considered the study eye and included in the study analyses. The eye included will be at the physician's discretion and only visits related to the study eye will be captured in the electronic Case Report Form (eCRF).
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.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
The decision regarding treatment is made at the discretion of the attending physician, according to his/her medical practice
Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
The decision regarding treatment is made at the discretion of the attending physician, according to his/her medical practice
Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
The decision regarding treatment is made at the discretion of the attending physician, according to his/her medical practice
Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
The decision regarding treatment is made at the discretion of the attending physician, according to his/her medical practice
Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Use of intravitreal aflibercept in routine clinical practice in Latin America
Mean change of visual acuity as measured by ETDRS or Snellen chart
ETDRS: Early treatment diabetic retinopathy study
Time frame: At baseline and 12 months
Mean change in visual acuity as measured by ETDRS or Snellen chart
Mean change in visual acuity between baseline and 12 months for the overall population (treatment naïve + previously treated patients) by indication, wAMD and DME.
Time frame: At baseline and 12 months
Change in retinal thickness as measured by OCT
OCT: Optical coherence tomography
Time frame: At baseline and 12 months
Mean time between injections by indication
Time frame: Up to 12 months
Mean number of injections by indication
Time frame: At 12 months
Duration of previous treatments by indication
In the previously treated subpopulation
Time frame: Up to 12 months
Type (anti-VEGF, laser, steroids, etc) of previous treatments by indication
In the previously treated subpopulation
Time frame: Up to 12 months
Percentage of patients with no fluid determined by OCT
Absence of fluid includes all types of fluid and would be determined by physicians judgment
Time frame: At 12 months
Percentage of patients achieving a Snellen equivalent of 20/40 or better
About 70 ETDRS(Early treatment diabetic retinopathy study) letters
Time frame: At 12 months
Percentage of patients gaining ≥15 ETDRS letter
Time frame: At 12 months
Presence/absence of pigment epithelium detachments (PED)
In the wAMD population
Time frame: At 12 months
Number of adjunctive therapies
In the DME population
Time frame: At 12 months
Type of adjunctive therapies based on medical records or on interviewing the patient
Time frame: At 12 months
Diabetic retinopathy severity (mild, moderate, severe)
In the DME population
Time frame: At 12 months
Reason to switch to intravitreal aflibercept based on medical records or on interviewing the patient
Time frame: At 12 months
Number of monitoring visits
Visits only for diagnostic purposes, but without injections
Time frame: At 12 months
Number of combined visits
Visits for monitoring and injection
Time frame: At 12 months
Number of visits outside the study center
Visits with other non-ophthalmology specialists, i.e. endocrinologists, family physician, etc.
Time frame: At 12 months
Number of optical coherence tomography (OCT) assessments per patient
Time frame: At 12 months
Number of visual acuity tests
Time frame: At 12 months
Number of fundoscopy examinations
Time frame: At 12 months
Plan to share: Undecided — Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Ran from Mar 2018 to primary completion in Sep 2020, 29 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 29 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 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.