Clinical trial NCT04420923: Optimizing the Treatment Strategy for Age-related Macular Degeneration
Official title: 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.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Wet Macular Degeneration
Keywords: Outcome Assessment, Health Care
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
name: Molde Hospital
name: Alesund Hospital
First posted: 2020-06-09
Enrollment: 250
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The purpose of the study is to test a new treatment protocol for wet macular degeneration, called "Observe and Plan", against today's standard protocol "Treat and Extend". Studies suggest that the individual treatment interval can be achieved earlier with "Observe-and-Plan" and that a proportion of patients do not need more than 3 injections, ie the loading dose. The other advantages seem to be that patients achieve good visual acuity with fewer controls and are more satisfied with the new protocol, which will be beneficial to both patients and health care. To our knowledge, no randomized controlled trial has tested this before.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Eyes formerly treated with anti-VEGF, photodynamic therapy, radiation therapy, transpupillary thermotherapy or focal laser photocoagulation involving the macular area.
* Geographic atrophy and subretinal fibrosis affecting the patient's visual acuity.
* Any other ongoing eye disease that influences patient's visual acuity, such as glaucoma with central vision loss, proliferative diabetic retinopathy, diabetic macular edema or chronic uveitis.

Primary outcomes:
measure: Visual acuity
timeFrame: 1 year
measure: Visual acuity
timeFrame: 2 years
Secondary outcomes:
measure: Patient satisfaction assessed by NEI-VFQ-25
timeFrame: 1 year
measure: Patient satisfaction assessed by NEI-VFQ-25
timeFrame: 2 years
measure: Number of injections
timeFrame: 1 year
measure: Number of controls
timeFrame: 1 year
measure: Number of injections
timeFrame: 2 years
measure: Number of controls
timeFrame: 2 years
Other outcomes:
Locations:
city: Molde
country: Norway
facility: Molde Hospital
city: Trondheim
country: Norway
facility: Dept. of Ophthalmology, St Olavs Hospital, Trondheim University Hospital
city: Ålesund
country: Norway
facility: Ålesund Hospital
Study officials:
affiliation: Norwegian University of Science and Technology, Fac MH, INB
name: Dordi Austeng, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinic of Ear-Nose-Throat, Eye and Maxillofacial Surgery, St. Olavs Hospital
name: Marit Fagerli, MD
role: STUDY_DIRECTOR
affiliation: Norwegian University of Science and Technology, Fac MH, INB
name: Jorunn Helbostad, Professor
role: STUDY_DIRECTOR
References:
citation: Mantel I, Niderprim SA, Gianniou C, Deli A, Ambresin A. Reducing the clinical burden of ranibizumab treatment for neovascular age-related macular degeneration using an individually planned regimen. Br J Ophthalmol. 2014 Sep;98(9):1192-6. doi: 10.1136/bjophthalmol-2013-304556. Epub 2014 Apr 10.