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

Completed

• Conditions: Retinal Vein Occlusion; Diabetic Macular Edema; Age Related Macular Degeneration
• Interventions: Procedure: Questionnaire; Other: Data collection up to 1 year

• Registration Number: NCT04395859
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-18
• Study First Submitted QC: 2020-05-19
• Study First Posted: 2020-05-20
• Study Start: 2020-05-27
• Primary Completion: 2021-12-15
• Study Completion: 2022-02-15
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-02
• Last Update Posted: 2022-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 233

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients treated with IVT before COVID19 pandemia	Data collection up to 1 year	Treatment started at least 6 months before the French confinement for COVID19 (15th march 2020)
Patients treated with IVT before COVID19 pandemia	Questionnaire	Treatment started at least 6 months before the French confinement for COVID19 (15th march 2020)

Primary Outcome Measures

Name	Time	Method
Change of visual acuity in patients treated with repeated IVT anti-angiogens during the COVID-19 epidemic	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

Trial Locations

Locations (4)

Centre Pôle Vision du val d'Ouest; 🇫🇷 Ecully, France

Fondation Adolphe de Rothschild; 🇫🇷 Paris, France

Hôpital Lariboisière; 🇫🇷 Paris, France

Centre ophtalmologique Maison Rouge; 🇫🇷 Strasbourg, France