- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07514559
Comparison of Intravitreal Anti-VEGF Treatment Burden in Different Retinal Diseases
April 1, 2026 updated by: Prof. Dr. Pia Vécsei-Marlovits, Hospital Hietzing
The study compares the perceived treatment burden in patients undergoing intravitreal anti-VEGF treatment for either wet age related macular degeneration, macular edema after retinal vein occlusions or diabetic macular edema.
This study is the first to the investigator's knowledge to compare treatment burden between all three patient groups, which also differ in age and socioeconomic circumstances.
The results are of interest to all ophthalmologists who prescribe anti-VEGF treatments, as they show factors which can influence patient adherence und thus the efficacy of said therapies.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
393
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Vienna, Austria, 1130
- Hietzing Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
393 patients (305 with nAMD, 55 with CME and 33 with DME)
Description
Inclusion Criteria:
- undergone a minimum of 5 IVT's and had visited the retina clinic for at least 6 months
Exclusion Criteria:
- eye surgery in the preceding six months
- notable cognitive impairment, such as dementia
- age <18 years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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AMD
Patients with AMD receiving anti-VEGF treatment
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DME
Patients with DME receiving anti-VEGF treatment
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RVO
Patients with RVO receiving anti-VEGF treatment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Severitiy of subjective treatment burden due to intravitreal anti-VEGF therapy assessed by questionnaire
Time Frame: From May 2023 to April 2024
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The questionnaire was designed on the basis of the Longitudinal assessment of Adherence Factors to Intravitreal (anti-VEGF) Therapy (LAF-IVT) questionnaire.
Patients were interviewed about their perceived treatment burden, their socioeconomic status, and demographic details.
Different aspects of treatment burden were graden by the patients as "no", "little", "moderate", "great" or "extreme buden".
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From May 2023 to April 2024
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2023
Primary Completion (Actual)
April 30, 2024
Study Completion (Actual)
April 30, 2024
Study Registration Dates
First Submitted
March 26, 2026
First Submitted That Met QC Criteria
April 1, 2026
First Posted (Actual)
April 7, 2026
Study Record Updates
Last Update Posted (Actual)
April 7, 2026
Last Update Submitted That Met QC Criteria
April 1, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EK 22-198-VK
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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