Actively Recruiting
Response to Aflibercept After Previous Intravitreal Ranibizumab Treatment in Neovascular Age-Related Macular Degeneration
Led by Medical University of Vienna · Updated on 2024-11-26
80
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Age-related macular degeneration (AMD) and diabetic retinopathy are common causes of visual disability in older adults. Neovascular AMD (nAMD) leads to early loss of central vision. This research evaluates the effects of switching from ranibizumab to aflibercept treatment in eyes with treatment naive, recurrent, or persistent nAMD, as well as diabetic retinopathy cases. The study includes patients previously treated with ranibizumab for up to one year and aims to understand the visual and anatomical changes after this switch. Participants will receive aflibercept therapy, and the study observes patients monthly over 12 months. The trial includes groups such as AMD patients previously treated with Lucentis (ranibizumab), treatment naive AMD patients, diabetic macular edema (DME) patients previously treated with ranibizumab, and treatment naive DME patients. The focus is on monitoring responses to aflibercept in these different patient groups. Throughout the study, participants will undergo comprehensive eye exams including best-corrected visual acuity (BCVA) tests, reading performance, standard ophthalmic checks, optical coherence tomography (OCT), fundus imaging, fluorescein and indocyanine green angiography, microperimetry, and OCT-based optical angiography. Researchers will measure changes in vision and macular anatomy over a year. The study also tracks retreatments and requires patients to attend regular monthly visits for monitoring and assessments.
CONDITIONS
Brief Title
Aflibercept in Recurrent or Persistent CNV
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 50 years or older
- Patients treated with ranibizumab for wet age-related macular degeneration for up to one year
- Best-corrected visual acuity (BCVA) of 20/400 or better in the study eye using ETDRS charts
- Willingness and ability to comply with regular monthly visits
- Signed informed consent form
You will not qualify if you...
- Any surgical treatment of the study eye within 3 months prior to baseline
- History of uncontrolled glaucoma in the study eye (intraocular pressure 25 mmHg despite treatment)
- Aphakia or absence of the posterior capsule (excluding YAG-capsulotomy) in the study eye
- Retinal pigment epithelial tear involving the macula in the study eye
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants receive Aflibercept injections for recurrent or persistent CNV after previous Ranibizumab treatment.
Monthly visits for up to 12 months
Duration - After completion of treatment up to 1 year
Participants are monitored to assess changes in visual acuity and anatomical outcomes after treatment.
Regular visits during the treatment period as part of monthly visits
Trial Site Locations
Total: 1 location
1
Medical University of Vienna
Vienna, Austria, 1090
Actively Recruiting
Research Team
R
Reinhard Told, MD, PhD
S
Stefan Sacu, Prof. PD. MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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