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)

NCT06723288 | Completed

• 1 other identifier: MR45734
• Study Type: observational
• Target: 736
• Locations: 1 country
• Sites: 20

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.

Conditions

Neovascular Age-related Macular Degeneration; Diabetic Macular Edema

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Cohort A: Previous Intravitreal (IVT) Injections (Yes/No)

  At study visit (Day 1)

Study Arms (2)

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.

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• For nAMD/DME participants:
• \- Diagnosis of nAMD/DME
• For healthy subjects:
• \- Normal visual function

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (20)

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital General de Catalunya

San Cugat Del Valles, Barcelona, 08195, Spain

Location

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

Location

Clinica Universitaria de Navarra

Pamplona, Navarre, 31008, Spain

Location

Instituto Oftalmologico Fernandez Vega

Oviedo, Principality of Asturias, 33012, Spain

Location

Oftalvist Valencia

Burjassot, Valencia, 46100, Spain

Location

Centro de Oftalmologia Barraquer

Barcelona, 08021, Spain

Location

Institut de la Macula i la retina

Barcelona, 08022, Spain

Location

Hospital Universitario Vall d Hebron

Barcelona, 08035, Spain

Location

Hospital Clínic i Provincial de Barcelona

Barcelona, 08036, Spain

Location

Hospital de la Arruzafa. Servicio de Oftalmologia

Córdoba, 14012, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario Fundacion Jimenez Diaz.

Madrid, 28040, Spain

Location

Clinica Baviera

Madrid, 28046, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario Virgen de la Macarena

Seville, 41007, Spain

Location

Hospital Virgen del Rocio

Seville, 41013, Spain

Location

Clinica Oftalmologica Aiken

Valencia, 46004, Spain

Location

Hospital Arnau de Vilanova (Valencia)

Valencia, 46015, Spain

Location

Hospital Universitario Rio Hortega

Valladolid, 47012, Spain

Location

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 9, 2024
• Study Start: December 31, 2024
• Primary Completion: November 28, 2025
• Study Completion: November 28, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (20)