A Randomised Controlled Trial Testing the Efficacy of the Treatment Strategy Observe-and-Plan Against Standard Treat-and-Extend in a Population of Newly Referred Patients With Age-related Macular Degeneration.
Who is this study for? Patients with Wet Macular Degeneration
Status: Active_not_recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The purpose of this study is to compare two different treatment protocols for wet macular degeneration; the new protocol called Observe and Plan against the current standard protocol Treat and Extend. Studies suggest that patients achieve equally good visual acuity with fewer controls and that they are more satisfied with the new protocol.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:
• diagnosed age-related macular degeneration according to criteria.
• new diagnose of active CNV verified with OCTA or FA / ICGA.
• BCVA ≥ 20/200 measured with ETDRS visual acuity chart
• written informed consent
Locations
Other Locations
Norway
Ålesund Hospital
Ålesund
Molde Hospital
Molde
Dept. of Ophthalmology, St Olavs Hospital, Trondheim University Hospital
Trondheim
Time Frame
Start Date: 2020-05-20
Completion Date: 2026-09
Participants
Target number of participants: 250
Treatments
Experimental: Observe-and-Plan
Patients will follow the same protocol as described by dr. Mantel et al. (2014) in the first Observe-and-Plan study conducted in Lausanne.
Active_comparator: Treat-and-Extend
Patients will follow the standard treatment protocol for Treat-and-Extend, used for several years in the participating clinics.
Related Therapeutic Areas
Sponsors
Leads: St. Olavs Hospital
Collaborators: Alesund Hospital, Molde Hospital, Norwegian University of Science and Technology