Actively Recruiting
Effectiveness of Switching from Ranibizumab to Aflibercept in Adults 50 and Older with Neovascular Age-Related Macular Degeneration and Diabetic Macular Edema
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
Research Team
R
Reinhard Told, MD, PhD
S
Stefan Sacu, Prof. PD. MD
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