Preventive TREatment of Dry Eye in Patients Receiving Repeated Intravitreal Injections for Age-related Macular Degeneration (TREDIA)

Age-related macular degeneration (AMD) is the 1st cause of visual impairment after the age of 50. Its most aggressive form, wet AMD, requires regular intravitreal injections (IVI) spaced 4 to 8 weeks apart usually depending on the treatment regimen and the patient's response. The IVI procedure requires a double disinfection with periocular and conjunctival cutaneous povidone-iodine. Antiseptic agents such as povidone iodine are a highly likely factor in the development of dry eye syndrome. Clinical data have demonstrated the abrasive and toxic effects of their use on the ocular surface, especially with repeated exposure (Saedon H, Nosek J, Phillips J. Ocular surface effects of repeated application of povisoden-iodine in patients receiving frequent intravitreal injections. Cutaneous and Ocular Toxicology. 2017;36(4):343-6.). The IVIS study coordinated by Prof. Dot reported impaired ocular surface and quality of life immediately after IVI. The authors suggest 3 levels of action to improve immediate tolerance: (i) improve the basal status of the ocular surface, (ii) reduce the contact time with povidone-iodine which could be toxic to the ocular surface and (iii) improve immediate post-IVI treatment. (Verrecchia S et al. A prospective multicentre study of intravitreal injections and ocular surface in 219 patients: IVIS study. Acta Ophthalmol. 2021 Mar 18). This study is part of the extension of the IVIS study. IVIs are effective and do not currently present a therapeutic alternative. However, their role in the development or exacerbation of dry eye is still poorly evaluated although millions of IVIs are performed each year worldwide (1.3 million in France in 2019). In addition, discomfort after injection is one of the factors that limit adherence to long-term IVI treatment, some patients fearing this repeated act. We propose in this bicentric, prospective, randomized, parallel group study, to evaluate in this context the impact of the continuous consideration of the risk of dry eye. The expected results are the objective improvement of dry eye indicators, comfort and quality of life of patients, all aimed at optimizing the adherence of our patients to their AMD treatment.

Study Overview

• Status: Recruiting
• Conditions: Age-Related Macular Degeneration; Dry Eye Syndromes
• Intervention / Treatment: Device: Preservative-free ophtalmic lubricant emulsion; Other: Routine treatment

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Corinne DOT, Pr.; Phone Number: +33 472 366 099; Email: corinne.dot@intradef.gouv.fr

Study Locations

• France
  • Bobigny, France, 93000
    • Not yet recruiting
    • Hôpital Avicenne
    • Contact: Audrey GIOCANTI-AUREGAN, Pr; Phone Number: +33 148 955 218; Email: audrey.giocanti@aphp.fr
  • Lyon, France, 69003
    • Recruiting
    • HIA Desgenettes
    • Contact: Corinne DOT, Pr.; Phone Number: +33 472 366 099; Email: corinne.dot@intradef.gouv.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patient treated for exudative AMD with at least one eye receiving IVI with an anti-VEGF for at least 12 months.
• Patient with at least one untreated dry eye symptom.
• Only one eye is included per patient. For patients injected bilaterally, the eye with the lowest TBUT will be included, otherwise the one with the highest Oxford score, otherwise the one with the lowest Schirmer score. If these 3 parameters are similar, the right eye will be included by default.
• Patient who has given informed consent to participate and understands the information related to the study.
• Patient affiliated with a social security plan or beneficiary of such a plan.
• Concurrent participation in non-interventional research is allowed. Concurrent participation in interventional research may be evaluated on a case-by-case basis by the Principal Investigator.

Exclusion Criteria:

• Patients with meatus plugs at inclusion.
• Eye surgery ≤ 3 months pre-inclusion (including laser or refractive).
• Anticholinergic* treatment prior to inclusion.
• Patients unable to maintain follow-up during the study period.
• Evidence of active ocular infection in either eye.
• History or presence of non-drying ocular surface disorders in either eye.
• Trauma or surgery to the eyelids.
• Any ocular or systemic pathology or treatment identified by the Investigator as likely to interfere with the results of the study.
• Hypersensitivity to any component of the medical device.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Preservative-free ophtalmic lubricant emulsion countinuous during 6 month after intravitreal Injections for Age-related macular degeneration	Device: Preservative-free ophtalmic lubricant emulsion; Use of a preservative-free ophtalmic lubricant emulsion continous during 6 months
Other: Routine treatment; Preservative-free ophtalmic lubricant emulsion during few days after intravitreal Injections for Age-related macular degeneration	Other: Routine treatment; Use of a preservative-free ophtalmic lubricant emulsion after each intravitreal injection during few days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean tear break-up time (TBUT) at the end of the study	Mean tear break-up time (TBUT) in seconds at the last study assessment. This is the standard measurement performed in routine care, which reduces the probability of missing data	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ocular surface alteration after 24 weeks	Ocular Staining Score d'Oxford	24 weeks

Collaborators and Investigators

• Sponsor: Direction Centrale du Service de Santé des Armées

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2023
• Primary Completion (Estimated): October 9, 2024
• Study Completion (Estimated): October 9, 2025

Study Registration Dates

• First Submitted: December 8, 2023
• First Submitted That Met QC Criteria: December 8, 2023
• First Posted (Actual): December 18, 2023

Study Record Updates

• Last Update Posted (Actual): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Macular Degeneration; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: 2022PPRC11; 2023-A00620-45 (Registry Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No