ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03290794
Recruitment Status : Not yet recruiting
First Posted : September 25, 2017
Last Update Posted : September 12, 2018
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Bayer

Brief 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 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)

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 Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
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 : September 28, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. Frequency of reported ocular and non-ocular adverse events during observation period [ Time Frame: Up to 6 months ]
    unilateral / bilateral treatment

  2. Percentage of reported ocular and non-ocular adverse events during observation period [ Time Frame: Up to 6 months ]
    unilateral / bilateral treatment


Secondary Outcome Measures :
  1. Type of ocular tests undertaken [ Time Frame: Up to 6 months ]
    e.g. Visual acuity, ocular computed tomography, indocyanine angiography, Angiography, Fundus photography

  2. Interval between ocular test [ Time Frame: Up to 6 months ]
    Date of ocular test

  3. Date of aflibercept injections [ Time Frame: Up to 6 months ]
    Date of aflibercept injections

  4. Injection dose [ Time Frame: Up to 6 months ]
    Injection dose

  5. Interval (days) between aflibercept injections [ Time Frame: Up to 6 months ]
    During observation periods

  6. Frequency of monitoring / clinic visits [ Time Frame: Up to 6 months ]
    Frequency of monitoring / clinic visits



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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 .
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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


Contacts
Contact: Bayer Clinical Trials Contact (+)1-888-84 22937 clinical-trials-contact@bayer.com

Locations
India
Many Locations Not yet recruiting
Multiple Locations, India
Sponsors and Collaborators
Bayer
Regeneron Pharmaceuticals

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03290794     History of Changes
Other Study ID Numbers: 19140
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases