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

NCT ID: NCT04395859

Last Updated: 2022-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

233 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-27

Study Completion Date

2022-02-15

Brief Summary

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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

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Conditions

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Age Related Macular Degeneration Diabetic Macular Edema Retinal Vein Occlusion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients treated with IVT before COVID19 pandemia

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

Questionnaire

Intervention Type PROCEDURE

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

Data collection up to 1 year

Intervention Type OTHER

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

Interventions

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Questionnaire

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

Intervention Type PROCEDURE

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martine MAUGET FAYSSE, MD

Role: PRINCIPAL_INVESTIGATOR

Fondation Adolphe de Rothschild

Locations

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Centre Pôle Vision du val d'Ouest

Écully, , France

Site Status

Fondation Adolphe de Rothschild

Paris, , France

Site Status

Hôpital Lariboisière

Paris, , France

Site Status

Centre ophtalmologique Maison Rouge

Strasbourg, , France

Site Status

Countries

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France

References

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Sukkarieh G, Bonnin S, Azar G, Lafolie J, Alonso AS, Erol O, Pineau J, Villain H, Guillaume J, Auge E, Mingou A, Lejoyeux R, Vasseur V, Mauget-Faysse M. Outcome of Patients Treated by Intravitreal Injections During the COVID-19 Lockdown: An Institutional Experience. Curr Eye Res. 2023 Jul;48(7):683-689. doi: 10.1080/02713683.2023.2200564. Epub 2023 Apr 12.

Reference Type DERIVED
PMID: 37024478 (View on PubMed)

Other Identifiers

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MMT_2020_15

Identifier Type: -

Identifier Source: org_study_id

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