Wet Age-related Macular DegenerationNCT03290794
Structured Post-marketing Surveillance to Collect the Safety Data of Intravitreal Aflibercept Injection (IVT-AFL) in Patients of Wet Age-related Macular Degeneration During Real World Clinical Practice
An observational study of Wet Age-related Macular Degeneration, run by Bayer at 1 site in India.
Trial summary
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: To collect safety data in wet AMD patients treated with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wet Age-related Macular Degeneration
- What is being tested?
- Aflibercept (Eylea, BAY86-5321)
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 14 Feb 2019to 26 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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 .
Who may be able to join
- Decision to treat with intravitreal aflibercept injection prior to patient enrolment as per the treating ophthalmologist's routine clinical practice.
- Adult patients with a diagnosis of wet AMD, as an indication approved by the local health authorities (DCGI) for use with intravitreal aflibercept injection.
- Patient or legal delegate signed informed consent.
Who cannot join
- Participation in a clinical trial of an investigational agent within 30 days.
- Patients receiving other anti-VEGF agent in fellow eye.
- Contraindications according to the local prescribing information.
Trial locations and contacts
1 site in 1 country.
About this study
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:
- To collect safety data in wet AMD patients treated with intravitreal aflibercept injection
The secondary objective is:
- To determine how disease activity is monitored including type and frequency of ocular tests and frequency of injections
Read the detailed description
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.
- Conditions
- Wet Age-related Macular Degeneration
- Being tested
- Aflibercept (Eylea, BAY86-5321)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflibercept (Eylea, BAY86-5321)Drug
Intravitreal Aflibercept as prescribed by the treating Physician
| Study group | Role | What they receive |
|---|---|---|
| Decision to treat with intravitreal aflibercept for wet AMD | Adult patients with a diagnosis of wet AMD, as an indication approved by the local health authorities for use with intravitreal aflibercept. Receives: Drug: Aflibercept (Eylea, BAY86-5321) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of reported ocular and non-ocular adverse events during observation period
unilateral / bilateral treatment
Measured: Up to 6 months
Percentage of reported ocular and non-ocular adverse events during observation period
unilateral / bilateral treatment
Measured: Up to 6 months
Secondary outcomes (6)
Type of ocular tests undertaken
e.g. Visual acuity, ocular computed tomography, indocyanine angiography, Angiography, Fundus photography
Measured: Up to 6 months
Interval between ocular test
Date of ocular test
Measured: Up to 6 months
Date of aflibercept injections
Date of aflibercept injections
Measured: Up to 6 months
Injection dose
Injection dose
Measured: Up to 6 months
Interval (days) between aflibercept injections
During observation periods
Measured: Up to 6 months
Frequency of monitoring / clinic visits
Frequency of monitoring / clinic visits
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start14 Feb 2019
- Primary completion25 Nov 2022
- Study completion26 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wet Age-related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03290794
- Sponsor's protocol ID
- 19140
- Status last verified
- Jun 2023
- First submitted
- 20 Sep 2017
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structured Post-marketing Surveillance to Collect the Safety Data of Intravitreal Aflibercept Injection (IVT-AFL) in Patients of Wet Age-related Macular Degeneration During Real World Clinical Practice
- ClinicalTrials.gov ID
- NCT03290794
- Acronym / sponsor ID
- 19140
- Conditions
- Wet Age-related Macular Degeneration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 14 Feb 2019 (actual)
- Primary completion
- 25 Nov 2022 (actual)
- Study completion
- 26 May 2023 (actual)
- First posted
- 25 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To collect safety data in wet AMD patients treated with intravitreal aflibercept injection
The secondary objective is:
- To determine how disease activity is monitored including type and frequency of ocular tests and frequency of injections
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Decision to treat with intravitreal aflibercept for wet AMD | – | Drug: Aflibercept (Eylea, BAY86-5321)Adult patients with a diagnosis of wet AMD, as an indication approved by the local health authorities for use with intravitreal aflibercept. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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 .
Key inclusion criteria (3 listed)
- Decision to treat with intravitreal aflibercept injection prior to patient enrolment as per the treating ophthalmologist's routine clinical practice.
- Adult patients with a diagnosis of wet AMD, as an indication approved by the local health authorities (DCGI) for use with intravitreal aflibercept injection.
- Patient or legal delegate signed informed consent.
Key exclusion criteria (3 listed)
- Participation in a clinical trial of an investigational agent within 30 days.
- Patients receiving other anti-VEGF agent in fellow eye.
- Contraindications according to the local prescribing information.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aflibercept (Eylea, BAY86-5321)Intravitreal Aflibercept as prescribed by the treating Physician | Drug | Decision to treat with intravitreal aflibercept for wet AMD |
Primary outcome
Frequency of reported ocular and non-ocular adverse events during observation period
Time frame: Up to 6 months
unilateral / bilateral treatment
Percentage of reported ocular and non-ocular adverse events during observation period
Time frame: Up to 6 months
unilateral / bilateral treatment
6 secondary outcomes
Type of ocular tests undertaken
Time frame: Up to 6 months
Interval between ocular test
Time frame: Up to 6 months
Date of aflibercept injections
Time frame: Up to 6 months
Injection dose
Time frame: Up to 6 months
Interval (days) between aflibercept injections
Time frame: Up to 6 months
Frequency of monitoring / clinic visits
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wet Age-related Macular Degeneration, run by Bayer at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of reported ocular and non-ocular adverse events during observation period (time frame: Up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2023.