Evaluating eye tissue thickness in healthy individuals and those with certain eye diseases
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
This study is testing how thick certain eye tissues are in people with specific eye diseases and comparing them to healthy individuals to learn more about their eye health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 854 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | Hoffmann-La Roche Industry-sponsored |
| Locations | 14 sites (Oviedo, Asturias and 13 other locations) |
| Trial ID | NCT06723288 on ClinicalTrials.gov |
What this trial studies
This observational study aims to measure the thickness of the conjunctiva and Tenon's capsule in participants diagnosed with neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME), as well as in age-matched healthy subjects. Using spectral domain-optical coherence tomography (SD-OCT), the study will gather in vivo measurements to better understand the differences in eye tissue among these groups. The findings may provide insights into the ocular health of individuals with these conditions compared to healthy individuals.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with nAMD or DME, as well as healthy subjects with normal visual function.
Not a fit: Patients with a history of ocular surgery, certain eye diseases, or those currently undergoing treatment for glaucoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of ocular changes in patients with nAMD and DME, potentially leading to improved diagnostic and treatment strategies.
How similar studies have performed: While this approach is observational and may have been explored in other contexts, the specific focus on conjunctiva and Tenon's capsule thickness in these conditions is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Oviedo, Asturias and 13 other locations
- Instituto Oftalmologico Fernandez Vega — Oviedo, Asturias, Spain (Recruiting)
- Hospital General de Catalunya — San Cugat Del Valles, Barcelona, Spain (Recruiting)
- Hospital Universitario Puerta de Hierro — Majadahonda, Madrid, Spain (Recruiting)
- Clinica Universitaria de Navarra — Pamplona, Navarra, Spain (Recruiting)
- Oftalvist Valencia — Burjassot, Valencia, Spain (Recruiting)
- Centro de Oftalmologia Barraquer — Barcelona, Spain (Recruiting)
- Institut de la Macula i la retina — Barcelona, Spain (Recruiting)
- Hospital Clínic i Provincial de Barcelona — Barcelona, Spain (Recruiting)
- Hospital de la Arruzafa. Servicio de Oftalmologia — Cordoba, Spain (Recruiting)
- Hospital Clinico San Carlos — Madrid, Spain (Recruiting)
- Clinica Baviera — Madrid, Spain (Recruiting)
- Clinica Oftalmologica Aiken — Valencia, Spain (Recruiting)
- Hospital Arnau de Vilanova (Valencia) — Valencia, Spain (Recruiting)
- Hospital Universitario Rio Hortega — Valladolid, Spain (Recruiting)
Study contacts
- Study coordinator: Reference Study ID Number: MR45734 https://forpatients.roche.com/
- Email: global-roche-genentech-trials@gene.com
- Phone: 888-662-6728 (U.S.)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.