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

Primary Purpose

Wet Macular Degeneration

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Observe and Plan
Treat-and-Extend
Sponsored by
St. Olavs Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wet Macular Degeneration focused on measuring Outcome Assessment, Health Care

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Molde HospitalRecruiting
  • Dept. of Ophthalmology, St Olavs Hospital, Trondheim University HospitalRecruiting
  • Ålesund HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Observe-and-Plan

Treat-and-Extend

Arm 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.

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

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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

Full Information

First Posted
June 4, 2020
Last Updated
June 9, 2022
Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology, Molde Hospital, Alesund Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04420923
Brief Title
Optimizing the Treatment Strategy for Age-related Macular Degeneration
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 8, 2020 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology, Molde Hospital, Alesund Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wet Macular Degeneration
Keywords
Outcome Assessment, Health Care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Observe-and-Plan
Arm Type
Experimental
Arm 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.
Arm Title
Treat-and-Extend
Arm Type
Active Comparator
Arm Description
Patients will follow the standard treatment protocol for Treat-and-Extend, used for several years in the participating clinics.
Intervention Type
Other
Intervention Name(s)
Observe and Plan
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Treat-and-Extend
Other Intervention Name(s)
Standard treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual acuity
Description
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.
Time Frame
1 year
Title
Visual acuity
Description
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
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Patient satisfaction assessed by NEI-VFQ-25
Description
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.
Time Frame
1 year
Title
Patient satisfaction assessed by NEI-VFQ-25
Description
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.
Time Frame
2 years
Title
Number of injections
Description
The number of injections will be counted for each participant.
Time Frame
1 year
Title
Number of controls
Description
The number of controls by the ophthalmologist will be counted for each participant.
Time Frame
1 year
Title
Number of injections
Description
The number of injections will be counted for each participant.
Time Frame
2 years
Title
Number of controls
Description
The number of controls by the ophthalmologist will be counted for each participant.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Margrete Sætre Hanssen, MD
Phone
+47 91871727
Email
margrete.saetre.hanssen@ntnu.no
First Name & Middle Initial & Last Name or Official Title & Degree
Dordi Austeng, MD PhD
Email
dordi.austeng@ntnu.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dordi Austeng, MD PhD
Organizational Affiliation
Norwegian University of Science and Technology, Fac MH, INB
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marit Fagerli, MD
Organizational Affiliation
Clinic of Ear-Nose-Throat, Eye and Maxillofacial Surgery, St. Olavs Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jorunn Helbostad, Professor
Organizational Affiliation
Norwegian University of Science and Technology, Fac MH, INB
Official's Role
Study Director
Facility Information:
Facility Name
Molde Hospital
City
Molde
Country
Norway
Individual Site Status
Recruiting
Facility Name
Dept. of Ophthalmology, St Olavs Hospital, Trondheim University Hospital
City
Trondheim
ZIP/Postal Code
N-7006
Country
Norway
Individual Site Status
Recruiting
Facility Name
Ålesund Hospital
City
Ålesund
Country
Norway
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
There is a plan to make IPD that underlie results in a publication and related data dictionaries available to other researchers.
IPD Sharing Time Frame
The data will be available on request after publication.
IPD Sharing Access Criteria
The requests will be evaluated by the research group at the institute.
Citations:
PubMed Identifier
24729031
Citation
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.
Results Reference
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Optimizing the Treatment Strategy for Age-related Macular Degeneration

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