Age Related Macular DegenerationCOVIDIVNCT04395859
Collateral Damage From the COVID-19 Pandemic Observed in Patients Treated With Intravitreal Injections (IVT) of Anti-angiogenic Agents
An observational study of Age Related Macular Degeneration and Diabetic Macular Edema, run by Fondation Ophtalmologique Adolphe de Rothschild at 4 sites in France.
Trial summary
In patients treated for exudative age-related macular degeneration (AMD), diabetes, retinal venous occlusion (OVR), or other conditions causing macular edema, treatments with anti-angiogenic intravitreal injections (IVT) are widely used both for their anti-angiogenic action. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Age Related Macular Degeneration, Diabetic Macular Edema, Retinal Vein Occlusion
- What is being tested?
- Questionnaire and Data collection up to 1 year
- Type of treatment
- Surgery or procedure
- How many people
- 233 participants
- Where
- 4 sitesFrance
- Study dates
- 27 May 2020to 15 Feb 2022
- Phase
- Observational
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients treated with repeated IVT treatment of anti-angiogenic drugs
Who may be able to join
- Ocular pathology requiring repeated IVT treatment of anti-angiogenic drugs (exudative AMD, diabetic macular edema or secondary to retinal venous occlusion ...)
- Beginning of IVT treatment repeated before 10/01/2019 (6 months before the start of French confinement)
Who cannot join
- Refusal to participate
Trial locations and contacts
4 sites in 1 country.
France4 sites
Centre Pôle Vision du val d'Ouest
Écully
Fondation Adolphe de Rothschild
Paris, 75019
Hôpital Lariboisière
Paris
Centre ophtalmologique Maison Rouge
Strasbourg
About this study
In patients treated for exudative age-related macular degeneration (AMD), diabetes, retinal venous occlusion (OVR), or other conditions causing macular edema, treatments with anti-angiogenic intravitreal injections (IVT) are widely used both for their anti-angiogenic action. Patients often have injections for many years, sometimes monthly or every 2 months.
The discontinuation of treatment with repeated injections of anti-angiogenic agents, linked to the COVID-19 coronavirus pandemic will potentially impact the visual acuity, the ophthalmological state and the quality of life of the patients concerned, therefore it is relevant to analyze the consequences the breakdown of usual care in this population.
- Being tested
- Questionnaire, Data collection up to 1 year
- Keywords
- Intravitreal Injections, Anti-angiogenics, COVID19
- Medical subject headings
- Macular Degeneration, Retinal Vein Occlusion, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireProcedure or surgery
At inclusion : Questionnaire collecting data concerning the interruption of IVT treatment
Data collection up to 1 yearOther
Data collection up to 1 year after resumption of follow-up: visual acuity, OCT : optical coherence tomography, IVT treatment, complications
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with IVT before COVID19 pandemia | Treatment started at least 6 months before the French confinement for COVID19 (15th march 2020) Receives: Procedure: Questionnaire; Other: Data collection up to 1 year |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of visual acuity in patients treated with repeated IVT anti-angiogens during the COVID-19 epidemic
Change from baseline (last visual acuity before confinement) and visual acuity 6 months after resumption of follow-up
Measured: Baseline (Before confinement) and 6 months after resumption 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 posted20 May 2020
- Study start27 May 2020
- Primary completion15 Dec 2021
- Study completion15 Feb 2022
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Martine MAUGET FAYSSE, MD, Principal investigator, Fondation Adolphe de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04395859
- Sponsor's protocol ID
- MMT_2020_15
- Acronym
- COVIDIV
- Status last verified
- Mar 2022
- First submitted
- 18 May 2020
- Last updated
- 3 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sukkarieh G, Bonnin S, Azar G, Lafolie J, Alonso AS, Erol O, Pineau J, Villain H, Guillaume J, Auge E, Mingou A, Lejoyeux R, Vasseur V, Mauget-Faysse M. Outcome of Patients Treated by Intravitreal Injections During the COVID-19 Lockdown: An Institutional Experience. Curr Eye Res. 2023 Jul;48(7):683-689. doi: 10.1080/02713683.2023.2200564. Epub 2023 Apr 12.
PubMed 37024478
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collateral Damage From the COVID-19 Pandemic Observed in Patients Treated With Intravitreal Injections (IVT) of Anti-angiogenic Agents
- ClinicalTrials.gov ID
- NCT04395859
- Acronym / sponsor ID
- COVIDIV / MMT_2020_15
- Keywords
- Intravitreal Injections, Anti-angiogenics, COVID19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 27 May 2020 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 20 May 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.
In patients treated for exudative age-related macular degeneration (AMD), diabetes, retinal venous occlusion (OVR), or other conditions causing macular edema, treatments with anti-angiogenic intravitreal injections (IVT) are widely used both for their anti-angiogenic action. Patients often have injections for many years, sometimes monthly or every 2 months.
The discontinuation of treatment with repeated injections of anti-angiogenic agents, linked to the COVID-19 coronavirus pandemic will potentially impact the visual acuity, the ophthalmological state and the quality of life of the patients concerned, therefore it is relevant to analyze the consequences the breakdown of usual care in this population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with IVT before COVID19 pandemia | – | Procedure: Questionnaire, Other: Data collection up to 1 yearTreatment started at least 6 months before the French confinement for COVID19 (15th march 2020) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients treated with repeated IVT treatment of anti-angiogenic drugs
Key inclusion criteria (2 listed)
- Ocular pathology requiring repeated IVT treatment of anti-angiogenic drugs (exudative AMD, diabetic macular edema or secondary to retinal venous occlusion ...)
- Beginning of IVT treatment repeated before 10/01/2019 (6 months before the start of French confinement)
Key exclusion criteria (1 listed)
- Refusal to participate
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 |
|---|---|---|
| QuestionnaireAt inclusion : Questionnaire collecting data concerning the interruption of IVT treatment | Procedure or surgery | Patients treated with IVT before COVID19 pandemia |
| Data collection up to 1 yearData collection up to 1 year after resumption of follow-up: visual acuity, OCT : optical coherence tomography, IVT treatment, complications | Other | Patients treated with IVT before COVID19 pandemia |
Primary outcome
Change of visual acuity in patients treated with repeated IVT anti-angiogens during the COVID-19 epidemic
Time frame: Baseline (Before confinement) and 6 months after resumption of follow-up
Change from baseline (last visual acuity before confinement) and visual acuity 6 months after resumption of follow-up
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 3 Mar 2022.
- Derived from this study: PubMed 37024478Sukkarieh G, Bonnin S, Azar G, Lafolie J, Alonso AS, Erol O, Pineau J, Villain H, Guillaume J, Auge E, Mingou A, Lejoyeux R, Vasseur V, Mauget-Faysse M. Outcome of Patients Treated by Intravitreal Injections During the COVID-19 Lockdown: An Institutional Experience. Curr Eye Res. 2023 Jul;48(7):683-689. doi: 10.1080/02713683.2023.2200564. Epub 2023 Apr 12.
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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.
Martine MAUGET FAYSSE, MD principal investigator
Fondation Adolphe de Rothschild
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age Related Macular Degeneration and Diabetic Macular Edema, run by Fondation Ophtalmologique Adolphe de Rothschild at 4 sites 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 2 inclusion and 1 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 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Change of visual acuity in patients treated with repeated IVT anti-angiogens during the COVID-19 epidemic (time frame: Baseline (Before confinement) and 6 months after resumption 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 NCT04395859, 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 3 Mar 2022.