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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Cohort A: Previous Intravitreal (IVT) Injections (Yes/No) | At study visit (Day 1) |
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Inclusion Criteria:
For nAMD/DME participants:
- Diagnosis of nAMD/DME
For healthy subjects:
- Normal visual function
Exclusion Criteria:
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Participants with nAMD or DME and age-matched healthy subjects from the general population.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Bellvitge | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain | ||
| Hospital General de Catalunya |
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| San Cugat Del Valles |
| Barcelona |
| 08195 |
| Spain |
| Hospital Universitario Puerta de Hierro | Majadahonda | Madrid | 28222 | Spain |
| Clinica Universitaria de Navarra | Pamplona | Navarre | 31008 | Spain |
| Instituto Oftalmologico Fernandez Vega | Oviedo | Principality of Asturias | 33012 | Spain |
| Oftalvist Valencia | Burjassot | Valencia | 46100 | Spain |
| Centro de Oftalmologia Barraquer | Barcelona | 08021 | Spain |
| Institut de la Macula i la retina | Barcelona | 08022 | Spain |
| Hospital Universitario Vall d Hebron | Barcelona | 08035 | Spain |
| Hospital Clínic i Provincial de Barcelona | Barcelona | 08036 | Spain |
| Hospital de la Arruzafa. Servicio de Oftalmologia | Córdoba | 14012 | Spain |
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario Fundacion Jimenez Diaz. | Madrid | 28040 | Spain |
| Clinica Baviera | Madrid | 28046 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Universitario Virgen de la Macarena | Seville | 41007 | Spain |
| Hospital Virgen del Rocio | Seville | 41013 | Spain |
| Clinica Oftalmologica Aiken | Valencia | 46004 | Spain |
| Hospital Arnau de Vilanova (Valencia) | Valencia | 46015 | Spain |
| Hospital Universitario Rio Hortega | Valladolid | 47012 | Spain |