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)

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06723288

Enrollment

736

Registered

2024-12-09

Start date

2024-12-31

Completion date

2025-11-28

Last updated

2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Macular Edema, Neovascular Age-related Macular Degeneration

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

45 Years to No maximum

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
Cohorts A and B: Conjunctival Thickness Measured Using SD-OCT	At study visit (Day 1)
Cohorts A and B: Tenon's Capsule Thickness Measured Using SD-OCT	At study visit (Day 1)
Cohorts A and B: Sum of Conjunctival and Tenon's Capsule Measured Using SD-OCT	At study visit (Day 1)
Cohorts A and B: Number of Participants in Age Groups 45-54, 55-64, 65-74, ≥75 Years	At study visit (Day 1)

Secondary

Measure	Time frame
Cohort A: Previous Intravitreal (IVT) Injections (Yes/No)	At study visit (Day 1)

Countries

Spain

Contacts

STUDY_DIRECTORClinical Trials

Hoffmann-La Roche

Outcome results