Optimizing the Treatment Strategy for Age-related Macular Degeneration

Not Applicable

Recruiting

• Conditions: Wet Macular Degeneration
• Interventions: Other: Treat-and-Extend; Other: Observe and Plan

• Registration Number: NCT04420923
• Lead Sponsor: St. Olavs Hospital

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.

Study Timeline

• Study First Submitted: 2020-06-04
• Study Start: 2020-06-08
• Study First Submitted QC: 2020-06-08
• Study First Posted: 2020-06-09
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-28
• Last Update Posted: 2023-12-29
• Primary Completion: 2023-12-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treat-and-Extend	Treat-and-Extend	Patients will follow the standard treatment protocol for Treat-and-Extend, used for several years in the participating clinics.
Observe-and-Plan	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.

Primary Outcome Measures

Name	Time	Method
Visual acuity	2 years	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

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction assessed by NEI-VFQ-25	2 years	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.
Number of injections	2 years	The number of injections will be counted for each participant.
Number of controls	2 years	The number of controls by the ophthalmologist will be counted for each participant.

Trial Locations

Locations (3)

Dept. of Ophthalmology, St Olavs Hospital, Trondheim University Hospital; 🇳🇴 Trondheim, Norway

Molde Hospital; 🇳🇴 Molde, Norway

Ålesund Hospital; 🇳🇴 Ålesund, Norway