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
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|ClinicalTrials.gov Identifier: NCT03290794|
Recruitment Status : Not yet recruiting
First Posted : September 25, 2017
Last Update Posted : December 10, 2018
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
|Condition or disease||Intervention/treatment|
|Wet Age-related Macular Degeneration||Drug: Aflibercept (Eylea, BAY86-5321)|
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 Type :||Observational|
|Estimated Enrollment :||100 participants|
|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|
|Estimated Study Start Date :||March 31, 2019|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||August 31, 2020|
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.
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 [ 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
- Type of ocular tests undertaken [ Time Frame: Up to 6 months ]e.g. Visual acuity, ocular computed tomography, indocyanine angiography, Angiography, Fundus photography
- Interval between ocular test [ Time Frame: Up to 6 months ]Date of ocular test
- Date of aflibercept injections [ Time Frame: Up to 6 months ]Date of aflibercept injections
- Injection dose [ Time Frame: Up to 6 months ]Injection dose
- Interval (days) between aflibercept injections [ Time Frame: Up to 6 months ]During observation periods
- Frequency of monitoring / clinic visits [ Time Frame: Up to 6 months ]Frequency of monitoring / clinic visits
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03290794
|Contact: Bayer Clinical Trials Contact||(+)1-888-84 firstname.lastname@example.org|
|Many Locations||Not yet recruiting|
|Multiple Locations, India|