Optimizing the Treatment Strategy for Age-related Macular Degeneration (OnP2)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Wet Macular Degeneration
• Intervention / Treatment: Other: Observe and Plan; Other: Treat-and-Extend

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.

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Margrete Sætre Hanssen, MD; Phone Number: +47 91871727; Email: margrete.saetre.hanssen@ntnu.no
• Study Contact Backup: Name: Dordi Austeng, MD PhD; Email: dordi.austeng@ntnu.no

Study Locations

• Norway
  • Molde, Norway
    • Recruiting
    • Molde Hospital
  • Trondheim, Norway, N-7006
    • Recruiting
    • Dept. of Ophthalmology, St Olavs Hospital, Trondheim University Hospital
  • Ålesund, Norway
    • Recruiting
    • Alesund Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Observe and Plan; First the individual interval between the injections of anti-VEGF (vascular endothelial growth factor) is established by observing the time from the loading dose to recurrence of the disease. The patient will come to control every four weeks to establish this interval. Second, the patient will receive injections at intervals that are two weeks shorter than the observed period. 2-3 injections are given before the next control. The control should be no later than six months ahead.
Active Comparator: Treat-and-Extend; Patients will follow the standard treatment protocol for Treat-and-Extend, used for several years in the participating clinics.	Other: Treat-and-Extend; At the first control 4 weeks after the loading dose, the ophthalmologist assesses whether the macula is still wet or whether the macula is dry. In case of wet macula, the patient receives a new injection on the same day and a new control in 4 weeks. If the macula is dry, the patient will return in 2 weeks for the next injection, ie the injection interval is extended from 4 to 6 weeks. Patients will be controlled every time they are to receive an intravitreal injection. If the macula is dry, the injection interval will be extended by 2 weeks and if the macula is wet the interval is shortened by 2 weeks. The shortest interval will be 4 weeks.; Other Names: Standard treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual acuity	Number of letters read at the ETDRS chart will be tested for each eye starting with a test distance of 2 meter, after correction of the refraction. A standardized testing protocol will be used both for refraction and the visual acuity test.	1 year
Visual acuity	Number of letters read at the ETDRS chart will be tested for each eye starting with a test distance of 2 meter, after correction of the refraction. A standardized testing protocol will be used both for refraction and the visual acuity test	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction assessed by NEI-VFQ-25	National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25). The VFQ-25 is a reliable and valid 25-item version of the 51-item National Eye Institute Visual Function Questionnaire (NEI-VFQ). It is especially useful in settings such as clinical trials, where interview length is a critical consideration.	1 year
Patient satisfaction assessed by NEI-VFQ-25	National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25). The VFQ-25 is a reliable and valid 25-item version of the 51-item National Eye Institute Visual Function Questionnaire (NEI-VFQ). It is especially useful in settings such as clinical trials, where interview length is a critical consideration.	2 years
Number of injections	The number of injections will be counted for each participant.	1 year
Number of controls	The number of controls by the ophthalmologist will be counted for each participant.	1 year
Number of injections	The number of injections will be counted for each participant.	2 years
Number of controls	The number of controls by the ophthalmologist will be counted for each participant.	2 years

Collaborators and Investigators

• Sponsor: St. Olavs Hospital
• Collaborators: Norwegian University of Science and Technology; Alesund Hospital; Molde Hospital
• Investigators: Study Director: Marit Fagerli, MD, Clinic of Ear-Nose-Throat, Eye and Maxillofacial Surgery, St. Olavs Hospital; Principal Investigator: Dordi Austeng, MD PhD, Norwegian University of Science and Technology, Fac MH, INB; Study Director: Jorunn Helbostad, Professor, Norwegian University of Science and Technology, Fac MH, INB

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2020
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: June 4, 2020
• First Submitted That Met QC Criteria: June 8, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): December 29, 2023
• Last Update Submitted That Met QC Criteria: December 28, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Outcome Assessment, Health Care
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Wet Macular Degeneration
• Other Study ID Numbers: 90953

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: There is a plan to make IPD that underlie results in a publication and related data dictionaries available to other researchers.
• IPD Sharing Time Frame: The data will be available on request after publication.
• IPD Sharing Access Criteria: The requests will be evaluated by the research group at the institute.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No