Collateral Damage From the COVID-19 Pandemic Observed in Patients Treated With Intravitreal Injections (IVT) of Anti-angiogenic Agents

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.

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Key information

Conditions

Age Related Macular Degeneration COVID-19 Cardiovascular Diseases Coronaviridae Infections Coronavirus Infections Diabetic Macular Edema Embolism and Thrombosis Eye Diseases Infections Lung Diseases Macular Degeneration Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Retinal Degeneration Retinal Diseases Retinal Vein Occlusion Thrombosis Vascular Diseases Venous Thrombosis Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondation Adolphe de Rothschild, Paris, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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)

Exclusion criteria

Refusal to participate

Treatment and study plan

Questionnaire

Procedure

At inclusion : Questionnaire collecting data concerning the interruption of IVT treatment

Data collection up to 1 year

Other

Data collection up to 1 year after resumption of follow-up: visual acuity, OCT : optical coherence tomography, IVT treatment, complications

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Acronym: COVIDIV

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2022
First posted: May 20, 2020
Registry last updated: Mar 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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