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Active, Not Recruiting

NCT Number: NCT04420923

Optimizing the Treatment Strategy for 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Wet Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Molde Hospital, Molde, Norway

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Observe and Plan

Other

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.

Treat-and-Extend

Other

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

Primary outcomes

  1. Visual acuity

    Time frame: 1 year

    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. Visual acuity

    Time frame: 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 outcomes

  1. Patient satisfaction assessed by NEI-VFQ-25

    Time frame: 1 year

    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. Patient satisfaction assessed by NEI-VFQ-25

    Time frame: 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.

  3. Number of injections

    Time frame: 1 year

    The number of injections will be counted for each participant.

  4. Number of controls

    Time frame: 1 year

    The number of controls by the ophthalmologist will be counted for each participant.

  5. Number of injections

    Time frame: 2 years

    The number of injections will be counted for each participant.

  6. Number of controls

    Time frame: 2 years

    The number of controls by the ophthalmologist will be counted for each participant.

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

  • Alesund Hospital
  • Molde Hospital
  • Norwegian University of Science and Technology

Registry information

Official study 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.

Acronym: OnP2

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Jun 9, 2020
Registry last updated
Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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