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

St. Olavs Hospital

Status: Active, not recruiting

Conditions: Wet Macular Degeneration

Treatments: Other: Observe and Plan; Other: Treat-and-Extend

Study type: Interventional

Funder types: Other

Identifiers

NCT04420923

90953

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Observe-and-Plan

Experimental group

Description:

Patients will follow the same protocol as described by dr. Mantel et al. (2014) in the first Observe-and-Plan study conducted in Lausanne.

Treatment:

Other: Observe and Plan

Treat-and-Extend

Active Comparator group

Description:

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

Treatment:

Other: Treat-and-Extend