Optimizing the Treatment Strategy for Age-related Macular Degeneration

Study Overview
=================
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.

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.

Conditions
-----------------
Wet Macular Degeneration

Intervention / Treatment
-----------------
* Other: Observe and Plan
* Other: Treat-and-Extend


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Observe-and-Plan<br>Patients will follow the same protocol as described by dr. Mantel et al. (2014) in the first Observe-and-Plan study conducted in Lausanne. | Other: Observe and Plan<br>* 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.<br>|
| Active Comparator: Treat-and-Extend<br>Patients will follow the standard treatment protocol for Treat-and-Extend, used for several years in the participating clinics. | Other: Treat-and-Extend<br>* 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.<br>* Other names: Standard treatment;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Number of injections | The number of injections will be counted for each participant. | 1 year | 
| Number of controls | The number of controls by the ophthalmologist will be counted for each participant. | 1 year | 
| Number of injections | The number of injections will be counted for each participant. | 2 years | 
| Number of controls | The number of controls by the ophthalmologist will be counted for each participant. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Outcome Assessment, Health Care