Response to Aflibercept After Previous Intravitreal Ranibizumab Treatment in Neovascular Age-Related Macular Degeneration

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

⁃ 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

Locations
Other Locations
Austria
Medical University of Vienna
RECRUITING
Vienna
Contact Information
Primary
Reinhard Told, MD, PhD
reinhard.told@meduniwien.ac.at
+43140400
Backup
Stefan Sacu, Prof. PD. MD
stefan.sacu@meduniwien.ac.at
+43140400
Time Frame
Start Date: 2015-12
Estimated Completion Date: 2025-12
Participants
Target number of participants: 80
Treatments
AMD patients previously teated with Lucentis
Adults ≥ 50 years; Patients who have been treated with ranibizumab due to wet age-related macular degeneration for up to one year; Patients who have a BCVA score better than 20/400 in the study eye using ETDRS; Willingness and ability to comply with regular visits; Signed informed consent form;~The patient can take his medicine in the prescribed manner. The prescribed drugs do not constitute an exclusion criteria.
treatment naive AMD patients
Adults ≥ 50 years; Patients who have a BCVA score better than 20/400 in the study eye using ETDRS;
DME patients previously teated with Lucentis
Adults ≥ 50 years; Patients who have been treated with ranibizumab due to DME for up to one year; Patients who have a BCVA score better than 20/400 in the study eye using ETDRS;
treatment naive DME patients
Adults ≥ 50 years; Patients who have a BCVA score better than 20/400 in the study eye using ETDRS;
Sponsors
Leads: Medical University of Vienna

This content was sourced from clinicaltrials.gov