NCT02669953 Aflibercept in Recurrent or Persistent CNV
| NCT ID | NCT02669953 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of Vienna |
| Condition | Age Related Macular Degeneration |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2015-12 |
| Primary Completion | 2025-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2015-12 with a primary completion date of 2025-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Age-related macular degeneration (AMD) and diabetic retinopathy are among the most common disorders causing visual disability in elderly people. AMD leads to dysfunction and loss of photoreceptors in the central retina. Neovascular AMD (nAMD) affects visual function early in the disease process. The purpose of the study is to evaluate the effect of switching from ranibizumab therapy to the current routine therapy using aflibercept in eyes with treatment naive, recurrent or persistent nAMD, treatment naive diabetic retinopathy and pretreated diabetic retinopathy. 20 patients with recurrent or persistent nAMD, previously treated with intravitreal ranibizumab for up to one year will be included in this trial. Patients will be examined in monthly intervals over 12 months follow-up. Examinations carried out will include: Best-corrected visual acuity (BCVA) using ETDRS charts at 4m distance, Reading Performance (RP), Standard ophthalmic examinations (SOE incl. funduscopy and applanation tonometry), Optical coherence tomography (OCT), Autofluorescence fundus image (AF) \& red-free autofluorescence fundus image (RF), Color fundus photography (CFP), Fluorescein angiography and indocyaningreen angiography (FLA/ICG), Microperimetry (MP), as well as Non-invasive OCT based optical angiography (AngioVue).
Eligibility Criteria
Inclusion Criteria: Adults ≥ 50 years * Patients who have been treated with ranibizumab due to wet age-related macular degeneration for up to one year * BCVA \>= 20/400 in the study eye using ETDRS * Willingness and ability to comply with regular visits * Signed informed consent Exclusion Criteria: * Any surgical treatment of the eye within 3 months prior to baseline in the study eye * History of uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma mediation) * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT02669953 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Age Related Macular Degeneration. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02669953 currently recruiting?
Yes, NCT02669953 is actively recruiting participants. Contact the research team at reinhard.told@meduniwien.ac.at for enrollment information.
Where is the NCT02669953 trial being conducted?
This trial is being conducted at Vienna, Austria.
Who is sponsoring the NCT02669953 clinical trial?
NCT02669953 is sponsored by Medical University of Vienna. The trial plans to enroll 80 participants.