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)

February 25, 2026 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

736

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Spain
- - Barcelona, Spain, 08036
    - Hospital Clinic i Provincial de Barcelona
  - Barcelona, Spain, 08022
    - Institut de la Macula i la retina
  - Barcelona, Spain, 08035
    - Hospital Universitario Vall d Hebron
  - Barcelona, Spain, 08021
    - Centro de Oftalmologia Barraquer
  - Córdoba, Spain, 14012
    - Hospital de la Arruzafa. Servicio de Oftalmologia
  - Madrid, Spain, 28040
    - Hospital Clinico San Carlos
  - Madrid, Spain, 28046
    - Hospital Universitario La Paz
  - Madrid, Spain, 28040
    - Hospital Universitario Fundacion Jimenez Diaz.
  - Madrid, Spain, 28046
    - Clinica Baviera
  - Seville, Spain, 41013
    - Hospital Virgen del Rocío
  - Seville, Spain, 41007
    - Hospital Universitario Virgen De La Macarena
  - Valencia, Spain, 46015
    - Hospital Arnau de Vilanova (Valencia)
  - Valencia, Spain, 46004
    - Clinica Oftalmologica Aiken
  - Valladolid, Spain, 47012
    - Hospital Universitario Río Hortega
- Barcelona
  - L'Hospitalet de Llobregat, Barcelona, Spain, 08907
    - Hospital Universitario de Bellvitge
  - San Cugat Del Valles, Barcelona, Spain, 08195
    - Hospital General De Catalunya
- Madrid
  - Majadahonda, Madrid, Spain, 28222
    - Hospital Universitario Puerta De Hierro
- Navarre
  - Pamplona, Navarre, Spain, 31008
    - Clínica Universitaria de Navarra
- Principality of Asturias
  - Oviedo, Principality of Asturias, Spain, 33012
    - Instituto Oftalmologico Fernandez Vega
- Valencia
  - Burjassot, Valencia, Spain, 46100
    - Oftalvist Valencia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Participants with nAMD or DME and age-matched healthy subjects from the general population.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Cohort A: nAMD/DME Participants Participants with nAMD/DME will be enrolled in this cohort given, they meet the eligibility criteria. The SD-OCT test will be conducted for all participants in this cohort.
Cohort B: Healthy Subjects Healthy subjects who meet the eligibility criteria will be enrolled in this cohort. The SD-OCT test will be conducted for all subjects in this cohort.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 31, 2024

Primary Completion (Actual)

November 28, 2025

Study Completion (Actual)

November 28, 2025

Study Registration Dates

First Submitted

December 4, 2024

First Submitted That Met QC Criteria