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)

Last updated: April 3, 2025
Sponsor: Hoffmann-La Roche
Overall Status: Active - Recruiting

Phase

N/A

Condition

Macular Degeneration

Diabetic Retinopathy

Diabetic Macular Edema

Treatment

N/A

Clinical Study ID

NCT06723288
MR45734
  • Ages > 45
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Inclusion Criteria:

For nAMD/DME participants:

  • Diagnosis of nAMD/DME

For healthy subjects:

  • Normal visual function

Exclusion

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 Design

Total Participants: 854
Study Start date:
December 31, 2024
Estimated Completion Date:
June 16, 2025

Connect with a study center

  • Instituto Oftalmologico Fernandez Vega

    Oviedo, Asturias 33012
    Spain

    Active - Recruiting

  • Hospital General de Catalunya

    San Cugat Del Valles, Barcelona 08195
    Spain

    Active - Recruiting

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid 28222
    Spain

    Active - Recruiting

  • Clinica Universitaria de Navarra

    Pamplona, Navarra 31008
    Spain

    Active - Recruiting

  • Oftalvist Valencia

    Burjassot, Valencia 46100
    Spain

    Active - Recruiting

  • Centro de Oftalmologia Barraquer

    Barcelona, 08021
    Spain

    Active - Recruiting

  • Hospital Clínic i Provincial de Barcelona

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Institut de la Macula i la retina

    Barcelona, 08022
    Spain

    Active - Recruiting

  • Hospital de la Arruzafa. Servicio de Oftalmologia

    Cordoba, 14012
    Spain

    Active - Recruiting

  • Clinica Baviera

    Madrid, 28046
    Spain

    Active - Recruiting

  • Clinica Oftalmologica Aiken

    Valencia, 46004
    Spain

    Active - Recruiting

  • Hospital Arnau de Vilanova (Valencia)

    Valencia, 46015
    Spain

    Active - Recruiting

  • Hospital Universitario Rio Hortega

    Valladolid, 47012
    Spain

    Active - Recruiting

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