Optimizing the Treatment Strategy for Age-related Macular Degeneration

Wet Macular Degeneration Clinical Trial

— OnP2  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04420923
• Other study ID #: 90953
• Status: Recruiting
• Phase: N/A
• Start date: June 8, 2020
• Est. completion date: June 30, 2025

Study information

• Verified date: December 2023
• Source: St. Olavs Hospital
• Contact: Margrete Sætre Hanssen, MD
• Phone: +47 91871727
• Email: margrete.saetre.hanssen[@]ntnu.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Macular Degeneration
• Wet Macular Degeneration

Intervention

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.
• 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.

Locations

Country	Name	City	State
Norway	Ålesund Hospital	Ålesund
Norway	Molde Hospital	Molde
Norway	Dept. of Ophthalmology, St Olavs Hospital, Trondheim University Hospital	Trondheim

Sponsors (4)

Lead Sponsor	Collaborator
St. Olavs Hospital	Alesund Hospital, Molde Hospital, Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Number of injections	The number of injections will be counted for each participant.	1 year
Secondary	Number of controls	The number of controls by the ophthalmologist will be counted for each participant.	1 year
Secondary	Number of injections	The number of injections will be counted for each participant.	2 years
Secondary	Number of controls	The number of controls by the ophthalmologist will be counted for each participant.	2 years