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

NCT04395859 | Completed

• 1 other identifier: MMT_2020_15
• Study Type: observational
• Target: 233
• Locations: 1 country
• Sites: 4

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.

Conditions

Age Related Macular Degeneration; Diabetic Macular Edema; Retinal Vein Occlusion

Keywords

Intravitreal Injections; Anti-angiogenics; COVID19

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patients treated with IVT before COVID19 pandemia

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

Procedure: Questionnaire; Other: Data collection up to 1 year

Interventions

Questionnaire PROCEDURE

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

Patients treated with IVT before COVID19 pandemia

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

Patients treated with IVT before COVID19 pandemia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated with repeated IVT treatment of anti-angiogenic drugs

You may qualify if:

• 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)

You may not qualify if:

• Refusal to participate

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (4)

Centre Pôle Vision du val d'Ouest

Écully, France

Location

Fondation Adolphe de Rothschild

Paris, 75019, France

Location

Hôpital Lariboisière

Paris, France

Location

Centre ophtalmologique Maison Rouge

Strasbourg, France

Location

Related Publications (1)

• 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.

  PMID: 37024478 DERIVED

MeSH Terms

Conditions

Macular Degeneration; Retinal Vein Occlusion; COVID-19

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Martine MAUGET FAYSSE, MD

  Fondation Adolphe de Rothschild

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: May 20, 2020
• Study Start: May 27, 2020
• Primary Completion: December 15, 2021
• Study Completion: February 15, 2022
• Last Updated: March 3, 2022

Record last verified: 2022-03

Locations

FR (4)