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OpenTrials
Completed

NCT Number: 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)

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.

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Key information

Conditions

Neovascular Age-related Macular Degeneration Diabetic Macular Edema

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Cohorts A and B: Conjunctival Thickness Measured Using SD-OCT

    Time frame: At study visit (Day 1)

  2. Cohorts A and B: Tenon's Capsule Thickness Measured Using SD-OCT

    Time frame: At study visit (Day 1)

  3. Cohorts A and B: Sum of Conjunctival and Tenon's Capsule Measured Using SD-OCT

    Time frame: At study visit (Day 1)

  4. 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)

Secondary outcomes

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

    Time frame: At study visit (Day 1)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 9, 2024
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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