Age-related Macular DegenerationREPERM-OCTNCT02868086
The Impact of Two Strategies in the Monitoring of Exudative ARMD on the Visual Acuity (by OCT B Scan or OCT Angiography)
A study testing OCT B-scans and OCT angiography in people with Age-related Macular Degeneration, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
The treatment of neovascular age-related macular degeneration (ARMD) is a major issue of public health. The therapeutic arsenal has widely grown throughout the years with the emergence of intra-vitreous anti-angiogenic treatments, under different surveillance protocols. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-related Macular Degeneration
- What is being tested?
- OCT B-scans and OCT angiography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteFrance
- Study dates
- 21 Oct 2016to 15 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Adult patient ≥ 50 years old
- with exudative ARMD,
- treated with intra-vitreous anti-angiogenics following a PRN protocol (pro re nata)
- Absence of atrophy of the central pigment epithelium
Who cannot join
- Opposition to participate in this research
- Persons enjoying legal protection measure
- Lack of affiliation to social security and universal health coverage
- Pregnant or lactating
- Another cause of Choroidal neovascularization
- Unbalanced glaucoma
- Eye surgery less than 3 months on the studied eye
Trial locations and contacts
1 site in 1 country.
About this study
The treatment of neovascular age-related macular degeneration (ARMD) is a major issue of public health. The therapeutic arsenal has widely grown throughout the years with the emergence of intra-vitreous anti-angiogenic treatments, under different surveillance protocols. The "PRN" surveillance (pro re nata: an on-demand treatment with monthly follow-up) allows a faster re-injection in case of neovascular relapse in order to maintain the best visual acuity. This therapeutic protocol is guided by the sub-retinal neovascular signs of activity. The monitoring is done during common practice via OCT B scans showing indirect signs of neovascular activity (exudation signs). OCT retinal imaging has been recently enriched with new programs allowing the visualization of sub-retinal neovessels without the use dyes (OCT angiography). The OCT angiography is automatically done by a program using standard OCT sections. During the monitoring of a patient using the OCT A, the signs of renewed neovascular activity are represented by an "arterialization" or the development of an arteriole network of the neovessel with the reappearance of a hyper reflective flow after a neovascular regressive phase. Indeed, the visualization of neovessels during the monitoring by Angio-OCT may lead to therapeutical modifications (anticipation of the injections). Knowing that the injection time-table of ARMD patients treated with anti-angiogenics is determined by sub-retinal neovascular signs of activity. This activity is evaluated during routine clinical practice by very specific signs, observable on OCT B scans. The hypothesis of this study is that the search of activity sins on the Angio-OCT, a new technic of image analysis performed on the OCT, may modify this injection time-table, with an impact of the patient's visual acuity.
- Conditions
- Age-related Macular Degeneration
- Being tested
- OCT B-scans, OCT angiography
- Keywords
- Age-related macular degeneration, Optical coherence tomography angiography
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT B-scansDevice
OCT angiographyDevice
| Study group | Role | What they receive |
|---|---|---|
| Tested patients | Experimental | Patients treated with anti-angiogenics for ARMD : monitoring using optical coherence tomography angiography Receives: Device: OCT angiography |
| Control patients | Active comparator | Patients treated with anti-angiogenics for ARMD : monitoring during common practice via optical coherence tomography B scans Receives: Device: OCT B-scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity improvement or stabilization
Proportion of patients with visual acuity improvement or stabilization
Measured: Between the inclusion and 1 year of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study start21 Oct 2016
- Primary completion20 Nov 2020
- Study completion15 Apr 2021
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 Age-related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02868086
- Sponsor's protocol ID
- MMT_2015_42
- Acronym
- REPERM-OCT
- Status last verified
- Jan 2026
- First submitted
- 11 Aug 2016
- Last updated
- 6 Jan 2026
- Results posted
- No
Publications
Sukkarieh G, Vasseur V, Lejoyeux R, Wolff B, Mauget-Faysse M. One-year outcome of neovascular age-related macular degeneration patients followed-up using different optical coherence tomography modalities. Eur J Ophthalmol. 2022 Nov;32(6):3503-3509. doi: 10.1177/11206721221088260. Epub 2022 Mar 14.
PubMed 35285308
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Two Strategies in the Monitoring of Exudative ARMD on the Visual Acuity (by OCT B Scan or OCT Angiography)
- ClinicalTrials.gov ID
- NCT02868086
- Acronym / sponsor ID
- REPERM-OCT / MMT_2015_42
- Conditions
- Age-related Macular Degeneration
- Keywords
- Age-related macular degeneration, Optical coherence tomography angiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 21 Oct 2016 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 16 Aug 2016 (estimated)
- 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 treatment of neovascular age-related macular degeneration (ARMD) is a major issue of public health. The therapeutic arsenal has widely grown throughout the years with the emergence of intra-vitreous anti-angiogenic treatments, under different surveillance protocols. The "PRN" surveillance (pro re nata: an on-demand treatment with monthly follow-up) allows a faster re-injection in case of neovascular relapse in order to maintain the best visual acuity. This therapeutic protocol is guided by the sub-retinal neovascular signs of activity. The monitoring is done during common practice via OCT B scans showing indirect signs of neovascular activity (exudation signs). OCT retinal imaging has been recently enriched with new programs allowing the visualization of sub-retinal neovessels without the use dyes (OCT angiography). The OCT angiography is automatically done by a program using standard OCT sections. During the monitoring of a patient using the OCT A, the signs of renewed neovascular activity are represented by an "arterialization" or the development of an arteriole network of the neovessel with the reappearance of a hyper reflective flow after a neovascular regressive phase. Indeed, the visualization of neovessels during the monitoring by Angio-OCT may lead to therapeutical modifications (anticipation of the injections). Knowing that the injection time-table of ARMD patients treated with anti-angiogenics is determined by sub-retinal neovascular signs of activity. This activity is evaluated during routine clinical practice by very specific signs, observable on OCT B scans. The hypothesis of this study is that the search of activity sins on the Angio-OCT, a new technic of image analysis performed on the OCT, may modify this injection time-table, with an impact of the patient's visual acuity.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tested patients | Experimental | Device: OCT angiographyPatients treated with anti-angiogenics for ARMD : monitoring using optical coherence tomography angiography |
| Control patients | Active comparator | Device: OCT B-scansPatients treated with anti-angiogenics for ARMD : monitoring during common practice via optical coherence tomography B scans |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patient ≥ 50 years old
- with exudative ARMD,
- treated with intra-vitreous anti-angiogenics following a PRN protocol (pro re nata)
- Absence of atrophy of the central pigment epithelium
Key exclusion criteria (7 listed)
- Opposition to participate in this research
- Persons enjoying legal protection measure
- Lack of affiliation to social security and universal health coverage
- Pregnant or lactating
- Another cause of Choroidal neovascularization
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 |
|---|---|---|
| OCT B-scans | Device | Control patients |
| OCT angiography | Device | Tested patients |
Primary outcome
Visual acuity improvement or stabilization
Time frame: Between the inclusion and 1 year of follow-up
Proportion of patients with visual acuity improvement or stabilization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Results publication: PubMed 35285308Sukkarieh G, Vasseur V, Lejoyeux R, Wolff B, Mauget-Faysse M. One-year outcome of neovascular age-related macular degeneration patients followed-up using different optical coherence tomography modalities. Eur J Ophthalmol. 2022 Nov;32(6):3503-3509. doi: 10.1177/11206721221088260. Epub 2022 Mar 14.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OCT B-scans and OCT angiography in people with Age-related Macular Degeneration, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
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 7 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: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 improvement or stabilization (time frame: Between the inclusion and 1 year of follow-up). 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 NCT02868086, 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 6 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.