An observational study in Wet Age-related Macular Degeneration, sponsored by Bayer. Completed at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-09.
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 18th largest by enrollment of the 20 observational ones that give a count, is one of 4 that started in 2019, is one of 20 observational ones, and was the 19th 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.
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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. 4 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 100 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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The proposed regulatory post-marketing surveillance (PMS) study will be planned to collect the safety data of aflibercept intravitreal injection in patients with wet Age-related Macular Degeneration (AMD) in real-life treatment practice
The primary objective is:
The secondary objective is:
The study will be multicenter, observational, prospective, single arm, post marketing surveillance study of intravitreal aflibercept injection in wet AMD patients in routine clinical practice and real-life conditions without any protocol mandated interventions.
Approximately 100 wet AMD patients from up to ten ophthalmology clinics across India will be enrolled in this study. Each study site will be requested to enroll approximately 10 patients, however, the sites will be asked to enrolled additional patients in case of failure to enroll 10 patients by other site to complete the recruitment of approximately 100 patients.
Patients will be observed for maximum period of 6 months after the start of intravitreal aflibercept treatment. The observation period should cover the entire period from initial visit to the last follow-up visit at six months or withdrawal of consent, or the patient is lost to follow up (whatever is earliest).
The study site will be asked to enroll into the study all consecutive patients with wet AMD for whom the decision has been made to treat with intravitreal aflibercept injection and patients agrees to sign informed consent form for data collection purpose.
Any switch to another therapy or initiated administration of other anti-VEGF (Vascular Endothelial Growth Factor) injection in fellow eye or the discontinuation of treatment with IVT-AFL before the 6 month implies the end of the observation period. However, the safety follow-up will continue at least 30 days after last intravitreal aflibercept injection or in case of the discontinuation of treatment with IVT-AFL or till the patient switch the treatment from IVT-AFL and received other anti-VEGF injection before the 6 month observation period.
Patients previously treated with any systemic or other intravitreal anti-VEGF treatment will be included in this study after the window period of 30 days to avoid the risks of unknown additive effects that might be associated with previous anti-VEGF treatments .
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.
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.
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.
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.
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.
Adult patients with a diagnosis of wet AMD, as an indication approved by the local health authorities for use with intravitreal aflibercept.
Drug: Aflibercept (Eylea, BAY86-5321)
Intravitreal Aflibercept as prescribed by the treating Physician
Frequency of reported ocular and non-ocular adverse events during observation period
unilateral / bilateral treatment
Time frame: Up to 6 months
Percentage of reported ocular and non-ocular adverse events during observation period
unilateral / bilateral treatment
Time frame: Up to 6 months
Type of ocular tests undertaken
e.g. Visual acuity, ocular computed tomography, indocyanine angiography, Angiography, Fundus photography
Time frame: Up to 6 months
Interval between ocular test
Date of ocular test
Time frame: Up to 6 months
Date of aflibercept injections
Date of aflibercept injections
Time frame: Up to 6 months
Injection dose
Injection dose
Time frame: Up to 6 months
Interval (days) between aflibercept injections
During observation periods
Time frame: Up to 6 months
Frequency of monitoring / clinic visits
Frequency of monitoring / clinic visits
Time frame: Up to 6 months
Plan to share: No — Availability of this study's data will later 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 Feb 2019 to primary completion in Nov 2022, 45 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 45 months is close to 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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