Optimizing the Treatment Strategy for Age-related Macular Degeneration

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.

Conditions

• Wet Macular Degeneration

Interventions

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.

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.

Sponsors & Collaborators

• Norwegian University of Science and Technology

  collaborator OTHER

• Molde Hospital

  collaborator OTHER

• Alesund Hospital

  collaborator OTHER

• St. Olavs Hospital

  lead OTHER

Principal Investigators

• Dordi Austeng, MD PhD · Norwegian University of Science and Technology, Fac MH, INB

• Marit Fagerli, MD · Clinic of Ear-Nose-Throat, Eye and Maxillofacial Surgery, St. Olavs Hospital

• Jorunn Helbostad, Professor · Norwegian University of Science and Technology, Fac MH, INB

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-05-20

Primary Completion

2025-09-30

Completion

2026-09-30

Countries

• Norway

Study Locations