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

Age-Related Macular Degeneration Clinical Trial

— TREDIA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06174181
• Other study ID #: 2022PPRC11
• Secondary ID: 2023-A00620-45
• Status: Recruiting
• Phase: N/A
• Start date: October 9, 2023
• Est. completion date: October 9, 2025

Study information

• Verified date: December 2023
• Source: Direction Centrale du Service de Santé des Armées
• Contact: Corinne DOT, Pr.
• Phone: +33 472 366 099
• Email: corinne.dot[@]intradef.gouv.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 9, 2025
• Est. primary completion date: October 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Macular Degeneration

Intervention

Device:
• Preservative-free ophtalmic lubricant emulsion
Use of a preservative-free ophtalmic lubricant emulsion continous during 6 months

Other:
• Routine treatment
Use of a preservative-free ophtalmic lubricant emulsion after each intravitreal injection during few days

Locations

Country	Name	City	State
France	Hopital Avicenne	Bobigny
France	HIA Desgenettes	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Direction Centrale du Service de Santé des Armées

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	ocular surface alteration after 24 weeks	Ocular Staining Score d'Oxford	24 weeks