A study to understand the real-life anti-vascular endothelial growth factor (anti-VEGF) treatment experiences and preferences of people living with neovascular age-related macular degeneration (nAMD, also known as wet AMD) or diabetic macular edema (DME)

Patient experience and preference study in neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME)

  • Wet Age-Related Macular Degeneration
  • Diabetic Macular Edema
Trial Status:

Active, not recruiting

This trial runs in
Cities
Trial Identifier:

MR41928

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      Results Disclaimer

      Trial Summary

      nAMD and DME are health conditions which affect the retina (the layer of cells at the back of the eye) and can eventually lead to vision loss and blindness if left untreated. These diseases can be treated by injecting a medication called anti-VEGF, into the eye which inhibits the growth of new blood vessels. Anti-VEGF treatment is effective in preserving and improving vision, and the quality of life of people with nAMD and DME. However, many patients miss injections or stop the treatment altogether. This non-interventional study wants to better understand the real-life treatment experiences of patients and their caregivers, with the goal of improving future nAMD and DME treatment plans.

      MR41928 Trial Identifier
      Both Gender
      18 Years or older Age
      Yes (caregivers) Healthy Volunteers

      Why is the non-interventional study needed?
      AMD and DME are health conditions which affect the retina (the layer of cells at the back of the eye) and can eventually lead to vision loss and blindness if left untreated. These diseases can be treated by injecting a medication called anti-VEGF into the eye, which inhibits the growth of new blood vessels. Anti-VEGF treatment is effective in preserving and improving vision, and the quality of life of people with nAMD and DME. However, many patients miss injections or stop the treatment altogether. This non-interventional study wants to better understand the real-life treatment experiences of patients and their caregivers, with the goal of improving future nAMD and DME treatment plans.

      How does the non-interventional study work?
      In a non-interventional study, treatment is provided according to routine medical practice and participants are not required to undergo any additional procedures as a result of taking part in the study. This non-interventional study is recruiting people who live with either nAMD or DME and have received anti-VEGF treatment during routine medical practice, and their caregivers. People’s experiences will be collected via survey to understand how anti-VEGF treatment performs in real-life situations. 

      People with nAMD or DME will complete a survey asking about demographic information, treatment history, vision-related functioning, treatment burden, preferences for treatment and treatment satisfaction. Completing the patient survey will take approximately 1 hour. 

      Caregivers will complete a survey asking about demographic information, their relationship with the care recipient, caregiving responsibilities, and perceptions around caregiving. Completing the caregiver survey will take approximately 30 minutes. 

      Participants can complete the survey via telephone, on paper, or online, and can stop the survey and leave the study at any time.

      What are the main objectives of the non-interventional study?
      The objectives of this study (the questions that this study wants to answer) include understanding:

      • The factors that best enable patients to follow their treatment plan
      • The key factors that would improve patient satisfaction with the treatment
      • How patients’ experiences with anti-VEGF injections relate to the effect on their vision
      • The burden of anti-VEGF injections and how the quality of life of patients and their caregivers may be affected by anti-VEGF treatment plans

      Who can take part in this non-interventional study?
      People living with nAMD or DME can take part in this non-interventional study if they: 

      • Are aged 18 years or older and have a clinical diagnosis of nAMD or DME 
      • Have received anti-VEGF treatment during routine medical practice that was started at least 6 months before March 2020, and have had their most recent eye injection within 6 months before joining the study 
      • Agree to share a minimum of 18-months of their medical records that are relevant to the study 

      Caregivers can take part if they: 

      • Are aged 18 years or older and are the primary caregiver of an adult patient with nAMD or DME
        • Primary caregivers are usually family or friends (not paid caregivers), and are the main person responsible for supporting people with nAMD or DME and accompanying them on treatment visits 

      People may not be able to take part in this non-interventional study if they:

      • Are enrolled in any clinical trial, or are receiving/have ever received anti-VEGF therapy in a clinical trial for retinal health conditions
      • Have previously experienced, or are currently experiencing certain retinal health conditions, or both nAMD and DME
      • Are considered to have certain psychiatric conditions or another condition that impairs memory or cognitive function that may prevent them from completing the survey

      What treatment will participants be given in this non-interventional study?
      Participants will not be given any investigational treatment during this study. Participants with nAMD or DME will have previously received, or may still be receiving, anti-VEGF eye injections as part of routine medical practice. Participants will not be required to take any additional treatment.

      Are there any risks or benefits in taking part in this non-interventional study?

      Risks associated with the study
      There are no known physical risks for patients or caregivers participating in this non-interventional study. All survey questions are aimed at understanding participants’ personal experiences and opinions. If participants have any questions or concerns about the survey they are free to share them with the study team.

      Potential benefits associated with the study
      Since this non-interventional study does not provide medical treatment, there is no direct benefit for patients or caregivers as a result of taking part, but the information that is collected may help other people living with a similar medical condition in the future. 

      Trial Summary

      nAMD and DME are health conditions which affect the retina (the layer of cells at the back of the eye) and can eventually lead to vision loss and blindness if left untreated. These diseases can be treated by injecting a medication called anti-VEGF, into the eye which inhibits the growth of new blood vessels. Anti-VEGF treatment is effective in preserving and improving vision, and the quality of life of people with nAMD and DME. However, many patients miss injections or stop the treatment altogether. This non-interventional study wants to better understand the real-life treatment experiences of patients and their caregivers, with the goal of improving future nAMD and DME treatment plans.

      MR41928 Trial Identifier
      Faricimab Treatments
      nAMD and DME Condition
      Official Title

      Patient experience and preference study in neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME)

      Eligibility Criteria

      Both Gender
      18 Years or older Age
      Yes (caregivers) Healthy Volunteers

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