Status:
COMPLETED
Preventive TREatment of Dry Eye in Patients Receiving Repeated Intravitreal Injections for Age-related Macular Degeneration
Lead Sponsor:
Direction Centrale du Service de Santé des Armées
Conditions:
Dry Eye Syndromes
Age-Related Macular Degeneration
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 14 2024
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT06174181
Start Date
October 9 2023
End Date
November 14 2024
Last Update
February 25 2025
Active Locations (2)
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1
Hopital Avicenne
Bobigny, France, 93000
2
HIA Desgenettes
Lyon, France, 69003