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| Name | Class |
|---|---|
| Norwegian University of Science and Technology | OTHER |
| Molde Hospital | OTHER |
| Alesund Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observe-and-Plan | Experimental | Patients will follow the same protocol as described by dr. Mantel et al. (2014) in the first Observe-and-Plan study conducted in Lausanne. |
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| Treat-and-Extend | Active Comparator | Patients will follow the standard treatment protocol for Treat-and-Extend, used for several years in the participating clinics. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dordi Austeng, MD PhD | Norwegian University of Science and Technology, Fac MH, INB | Principal Investigator |
| Marit Fagerli, MD | Clinic of Ear-Nose-Throat, Eye and Maxillofacial Surgery, St. Olavs Hospital | Study Director |
| Jorunn Helbostad, Professor | Norwegian University of Science and Technology, Fac MH, INB | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ã…lesund Hospital | Ã…lesund | Norway | ||||
| Molde Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24729031 | Background | 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. |
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There is a plan to make IPD that underlie results in a publication and related data dictionaries available to other researchers.
The data will be available on request after publication.
The requests will be evaluated by the research group at the institute.
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| ID | Term |
|---|---|
| D057135 | Wet Macular Degeneration |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| 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. |
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| 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 |
| Molde |
| Norway |
| Dept. of Ophthalmology, St Olavs Hospital, Trondheim University Hospital | Trondheim | N-7006 | Norway |