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

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild (Other)

Overall Status

Completed

CT.gov ID

NCT04395859

Collaborator

(none)

233

Enrollment

Locations

20.7

Actual Duration (Months)

58.3

Patients Per Site

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Age Related Macular Degeneration Diabetic Macular Edema Retinal Vein Occlusion	Procedure: Questionnaire Other: Data collection up to 1 year

Study Design

Study Type:

Observational

Actual Enrollment :

233 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 27, 2020

Actual Primary Completion Date :

Dec 15, 2021

Actual Study Completion Date :

Feb 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Patients treated with IVT before COVID19 pandemia Treatment started at least 6 months before the French confinement for COVID19 (15th march 2020)	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

Arm

Intervention/Treatment

Patients treated with IVT before COVID19 pandemia

Treatment started at least 6 months before the French confinement for COVID19 (15th march 2020)

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Centre Pôle Vision du val d'Ouest	Ecully	France
2	Fondation Adolphe de Rothschild	Paris	France	75019
3	Hôpital Lariboisière	Paris	France
4	Centre ophtalmologique Maison Rouge	Strasbourg	France