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

Diabetic Macular Edema Clinical Trial

— COVIDIV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04395859
• Other study ID #: MMT_2020_15
• Status: Completed
• Start date: May 27, 2020
• Est. completion date: February 15, 2022

Study information

• Verified date: March 2022
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 233
• Est. completion date: February 15, 2022
• Est. primary completion date: December 15, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• COVID-19
• Diabetic Macular Edema
• Macular Degeneration
• Macular Edema
• Retinal Vein Occlusion

Intervention

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

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

Locations

Country	Name	City	State
France	Centre Pôle Vision du val d'Ouest	Ecully
France	Fondation Adolphe de Rothschild	Paris
France	Hôpital Lariboisière	Paris
France	Centre ophtalmologique Maison Rouge	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline (Before confinement) and 6 months after resumption of follow-up