ITMO public health
Last update : 04/21/2021 | Version : 1 | ID : 73553
| General | |
| Identification | |
| Detailed name | Collateral damage of the COVID-19 pandemic observed among patients receiving treatment with intravitreal (IVT) injections of antiangiogenic agents |
| Sign or acronym | COVIDIV |
| General Aspects | |
| Medical area |
Ophthalmology |
| Study in connection with Covid-19 |
Yes |
| Pathology (details) | Exudative ARMD, diabetes, retinal vein occlusion (RVO), or other disorders causing macular oedema |
| Scientific investigator(s) (Contact) | |
| Name of the director | Mauget-Faÿsse |
| Surname | Martine |
| Address | Hôpital Fondation A. de Rothschild, PIC-CIC, 29 rue Manin 75019 PARIS |
| Phone | 01 48 03 64 37 |
| Organization | Foundation A. de Rothschild Hospital |
| Collaborations | |
| Participation in projects, networks and consortia |
No |
| Funding | |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Foundation A. de Rothschild Hospital/Clinical Research Unit |
| Organisation status |
Both |
| Presence of scientific or steering committees |
No |
| Additional contact | |
| Name of the contact | VACHEY |
| Surname | Patrick |
| Address | Hôpital Fondation A. de Rothschild, PIC-CIC, 29 rue Manin 75019 PARIS |
| Phone | 01 48 03 64 33 |
| pvachey@for.paris | |
| Organization | Hôpital Fondation A. de Rothschild |
| Name of the contact | THEVENIN |
| Surname | Sophie |
| Address | Hôpital Fondation A. de Rothschild, PIC-CIC, 29 rue Manin 75019 PARIS |
| Phone | 01 48 03 65 96 |
| sthevenin@for.paris | |
| Organization | Hôpital Fondation A. de Rothschild |
| Main features | |
| Type of database | |
| Type of database |
Others |
| Specify | Questionnaire at inclusion + follow-up data taken from the medical records |
| Database recruitment is is made on the basis of: |
Medication(s) taken |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | Patient information following their first visit after the first lockdown on 11/05/2021: Patients contacted by telephone or informed during appointments. |
| Database objective | |
| Main objective | Describe the changes in visual acuity among patients receiving treatment with repeat IVT injections of antiangiogenic agents during the COVID-19 epidemic, between September 2019 and May 2021 |
| Inclusion criteria |
Patient aged 18 years and over
-Eye disorder requiring treatment with repeat IVT injections of antiangiogenic agents: Exudative ARMD, macular oedema associated with diabetes or secondary to retinal vein occlusion. -Initiation of treatment with repeat IVT injections before 01/10/2019 |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population covered |
Sick population |
| Pathology | H35 - Other retinal disorders |
| Gender |
Male Woman |
| Geography area |
National |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2020 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 1,500 planned - actual number included: 233 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data |
| Clinical data (detail) |
Direct physical measures |
| Details of collected clinical data | Treatment with IVT injections, outcome of the treated disorder |
| Declarative data (detail) |
Phone interview |
| Details of collected declarative data | Questionnaire on visits during the lockdown |
| Presence of a biobank |
No |
| Procedures | |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Follow-up with data in the medical records up to a year after resuming follow-up after 11/05/2021 |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access |
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