Clinical trial NCT06723288: A Study Conducted to Evaluate the Conjunctiva and Tenon's Capsule Status of Healthy Subjects and in Participants With Neovascular Age-related Macular Degeneration (nAMD)/Diabetic Macular Edema (DME)
Official title: A Multicenter, Cross-sectional Study to Describe the Conjunctiva and Tenon's Capsule Status of Healthy Subjects and nAMD/DME Patients Followed in Clinical Practice in Spain
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neovascular Age-related Macular Degeneration
Diabetic Macular Edema
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2024-12-09
Enrollment: 854
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with nAMD or DME and age-matched healthy subjects from the general population.

Brief summary: The purpose of this study is to obtain conjunctiva and tenon's capsule thickness measurements in vivo using spectral domain-optical coherence tomography (SD-OCT) in participants with nAMD/DME and age-matched healthy subjects.


Eligibility criteria: Inclusion Criteria:

For nAMD/DME participants:

- Diagnosis of nAMD/DME

For healthy subjects:

- Normal visual function

Exclusion Criteria:

* Current or past treatment for glaucoma (only for healthy subjects)
* Dry eye disease except those treated only with artificial tears
* Ocular hypertension treated with hypotensive drugs
* Pterygium
* Strabismus
* Previous ocular surgery except cataract surgery
* Cataract surgery with scleral incision
* Current contact lens wearers
* Myopia with more than 6 diopters
* Corneal transplant
* History of ocular surface inflammation
* Active or recent conjunctivitis infection
* Pregnancy
* Participant who has already received an IVT injection in the superotemporal quadrant (only for nAMD/DME participants)

Primary outcomes:
measure: Cohorts A and B: Conjunctival Epithelium Thickness Measured Using SD-OCT
timeFrame: At study visit (Day 1)
measure: Cohorts A and B: Conjunctival Stroma Thickness Measured Using SD-OCT
timeFrame: At study visit (Day 1)
measure: Cohorts A and B: Tenon's Capsule Thickness Measured Using SD-OCT
timeFrame: At study visit (Day 1)
measure: Cohorts A and B: Sum of Conjunctival Epithelium Thickness, Conjunctival stroma and Tenon's Capsule Measured Using SD-OCT
timeFrame: At study visit (Day 1)
measure: Cohorts A and B: Number of Participants in Age Groups 45-54, 55-64, 65-74, >=75
timeFrame: At study visit (Day 1)
Secondary outcomes:
measure: Cohort A: Previous Intravitreal (IVT) Injections (Yes/No)
timeFrame: At study visit (Day 1)
measure: Cohorts A and B: Conjunctival Epithelium Thickness Measured Using SS-OCT
timeFrame: At study visit (Day 1)
measure: Cohorts A and B: Conjunctival Stroma Thickness Measured Using SS-OCT
timeFrame: At study visit (Day 1)
measure: Cohorts A and B: Tenon's Capsule Thickness Measured Using SS-OCT
timeFrame: At study visit (Day 1)
measure: Cohorts A and B: Sum of Conjunctival Epithelium Thickness, Conjunctival stroma and Tenon's Capsule Measured Using SS-OCT
timeFrame: At study visit (Day 1)
measure: Cohorts A and B: Scleral Thickness Measured Using SS-OCT
timeFrame: At study visit (Day 1)
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: Instituto Oftalmologico Fernandez Vega
state: Asturias
city: San Cugat Del Valles
country: Spain
facility: Hospital General de Catalunya
state: Barcelona
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra
state: Navarra
city: Burjassot
country: Spain
facility: Oftalvist Valencia
state: Valencia
city: Barcelona
country: Spain
facility: Centro de Oftalmologia Barraquer
city: Barcelona
country: Spain
facility: Institut de la Macula i la retina
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial de Barcelona
city: Cordoba
country: Spain
facility: Hospital de la Arruzafa. Servicio de Oftalmologia
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz.
city: Madrid
country: Spain
facility: Clinica Baviera
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocio
city: Valencia
country: Spain
facility: Clinica Oftalmologica Aiken
city: Valencia
country: Spain
facility: Hospital Arnau de Vilanova (Valencia)
city: Valladolid
country: Spain
facility: Hospital Universitario Rio Hortega
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: