CompletedNot Applicable

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)

Spain736 participantsStarted 2024-12-31

Plain-language 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.

Who can participate

Age range

45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: At study visit (Day 1)

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

Timeframe: At study visit (Day 1)

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

Timeframe: At study visit (Day 1)

Cohorts A and B: Number of Participants in Age Groups 45-54, 55-64, 65-74, ≥75 Years

Timeframe: At study visit (Day 1)

Trial details

NCT IDNCT06723288

SponsorHoffmann-La Roche

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-11-28

View on ClinicalTrials.gov More Neovascular Age-related Macular Degeneration trials

Who can participate

Age range

45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: At study visit (Day 1)

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

Timeframe: At study visit (Day 1)

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

Timeframe: At study visit (Day 1)

Cohorts A and B: Number of Participants in Age Groups 45-54, 55-64, 65-74, ≥75 Years

Timeframe: At study visit (Day 1)