Wet Macular DegenerationOnP2NCT04420923
Optimizing the Treatment Strategy for Age-related Macular Degeneration
A study testing Observe and Plan and Treat-and-Extend in people with Wet Macular Degeneration, run by St. Olavs Hospital at 3 sites in Norway.
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". Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Wet Macular Degeneration
- What is being tested?
- Observe and Plan and Treat-and-Extend
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 3 sitesNorway
- Study dates
- 20 May 2020to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
Norway3 sites
Ålesund Hospital
Ålesund
Molde Hospital
Molde
Dept. of Ophthalmology, St Olavs Hospital, Trondheim University Hospital
Trondheim, N-7006
About this study
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.
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.
Read the 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.
- Conditions
- Wet Macular Degeneration
- Being tested
- Observe and Plan, Treat-and-Extend
- Keywords
- Outcome Assessment, Health Care
- Medical subject headings
- Wet Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observe and PlanOther
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-ExtendOther
Also called Standard treatment
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Observe and Plan |
| Treat-and-Extend | Active comparator | Patients will follow the standard treatment protocol for Treat-and-Extend, used for several years in the participating clinics. Receives: Other: Treat-and-Extend |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 2 years
Secondary outcomes (6)
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.
Measured: 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.
Measured: 2 years
Number of injections
The number of injections will be counted for each participant.
Measured: 1 year
Number of controls
The number of controls by the ophthalmologist will be counted for each participant.
Measured: 1 year
Number of injections
The number of injections will be counted for each participant.
Measured: 2 years
Number of controls
The number of controls by the ophthalmologist will be counted for each participant.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start20 May 2020
- Primary completionSep 2025 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wet Macular DegenerationStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology, Molde Hospital, Alesund Hospital
- Responsible party
- Sponsor
- Investigators
- Dordi Austeng, MD PhD, Principal investigator, Norwegian University of Science and Technology, Fac MH, INBMarit Fagerli, MD, Study director, Clinic of Ear-Nose-Throat, Eye and Maxillofacial Surgery, St. Olavs HospitalJorunn Helbostad, Professor, Study director, Norwegian University of Science and Technology, Fac MH, INB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04420923
- Sponsor's protocol ID
- 90953
- Acronym
- OnP2
- Status last verified
- Jun 2025
- First submitted
- 4 Jun 2020
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a plan to make IPD that underlie results in a publication and related data dictionaries available to other researchers.
Publications
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.
PubMed 24729031
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04420923
- Acronym / sponsor ID
- OnP2 / 90953
- Conditions
- Wet Macular Degeneration
- Keywords
- Outcome Assessment, Health Care
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology, Molde Hospital, Alesund Hospital
- Study start
- 20 May 2020 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observe-and-Plan | Experimental | Other: Observe and PlanPatients will follow the same protocol as described by dr. Mantel et al. (2014) in the first Observe-and-Plan study conducted in Lausanne. |
| Treat-and-Extend | Active comparator | Other: Treat-and-ExtendPatients will follow the standard treatment protocol for Treat-and-Extend, used for several years in the participating clinics. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observe and PlanFirst 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. | Other | Observe-and-Plan |
| Treat-and-ExtendAlso: Standard treatmentAt 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. | Other | Treat-and-Extend |
Primary outcome
Visual acuity
Time frame: 1 year
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
Time frame: 2 years
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
6 secondary outcomes
Patient satisfaction assessed by NEI-VFQ-25
Time frame: 1 year
Patient satisfaction assessed by NEI-VFQ-25
Time frame: 2 years
Number of injections
Time frame: 1 year
Number of controls
Time frame: 1 year
Number of injections
Time frame: 2 years
Number of controls
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Background: PubMed 24729031Mantel 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.
- Individual participant dataSharing planned: Yes. There is a plan to make IPD that underlie results in a publication and related data dictionaries available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dordi Austeng, MD PhD principal investigator
Norwegian University of Science and Technology, Fac MH, INB
Marit Fagerli, MD study director
Clinic of Ear-Nose-Throat, Eye and Maxillofacial Surgery, St. Olavs Hospital
Jorunn Helbostad, Professor study director
Norwegian University of Science and Technology, Fac MH, INB
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Observe and Plan and Treat-and-Extend in people with Wet Macular Degeneration, run by St. Olavs Hospital at 3 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04420923, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.