Neovascular Age-related Macular DegenerationNCT06723288
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)
An observational study of Neovascular Age-related Macular Degeneration and Diabetic Macular Edema, run by Hoffmann-La Roche at 20 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neovascular Age-related Macular Degeneration, Diabetic Macular Edema
- How many people
- 736 participants
- Where
- 20 sitesSpain
- Study dates
- 31 Dec 2024to 28 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants with nAMD or DME and age-matched healthy subjects from the general population.
Who may be able to join
- For nAMD/DME participants:
- Diagnosis of nAMD/DME
- For healthy subjects:
- Normal visual function
Who cannot join
- 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
Show all 14Show fewer
- 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)
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Spain20 sites
Centro de Oftalmologia Barraquer
Barcelona, 08021
Institut de la Macula i la retina
Barcelona, 08022
Hospital Universitario Vall d Hebron
Barcelona, 08035
Hospital Clínic i Provincial de Barcelona
Barcelona, 08036
Oftalvist Valencia
Burjassot, Valencia, 46100
Hospital de la Arruzafa. Servicio de Oftalmologia
Córdoba, 14012
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital Clinico San Carlos
Madrid, 28040
Hospital Universitario Fundacion Jimenez Diaz.
Madrid, 28040
Clinica Baviera
Madrid, 28046
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222
Instituto Oftalmologico Fernandez Vega
Oviedo, Principality of Asturias, 33012
Clinica Universitaria de Navarra
Pamplona, Navarre, 31008
Hospital General de Catalunya
San Cugat Del Valles, Barcelona, 08195
Hospital Universitario Virgen de la Macarena
Seville, 41007
Hospital Virgen del Rocio
Seville, 41013
Clinica Oftalmologica Aiken
Valencia, 46004
Hospital Arnau de Vilanova (Valencia)
Valencia, 46015
Hospital Universitario Rio Hortega
Valladolid, 47012
About this study
Official 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
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohorts A and B: Conjunctival Thickness Measured Using SD-OCT
Measured: At study visit (Day 1)
Cohorts A and B: Tenon's Capsule Thickness Measured Using SD-OCT
Measured: At study visit (Day 1)
Cohorts A and B: Sum of Conjunctival and Tenon's Capsule Measured Using SD-OCT
Measured: At study visit (Day 1)
Cohorts A and B: Number of Participants in Age Groups 45-54, 55-64, 65-74, ≥75 Years
Measured: At study visit (Day 1)
Secondary outcomes (1)
Cohort A: Previous Intravitreal (IVT) Injections (Yes/No)
Measured: At study visit (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start31 Dec 2024
- Primary completion28 Nov 2025
- Study completion28 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular Age-related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 736 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06723288
- Sponsor's protocol ID
- MR45734
- Status last verified
- Feb 2026
- First submitted
- 4 Dec 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06723288
- Acronym / sponsor ID
- MR45734
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 736 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 31 Dec 2024 (actual)
- Primary completion
- 28 Nov 2025 (actual)
- Study completion
- 28 Nov 2025 (actual)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with nAMD or DME and age-matched healthy subjects from the general population.
Key inclusion criteria (4 listed)
- Diagnosis of nAMD/DME
- Normal visual function
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cohorts A and B: Conjunctival Thickness Measured Using SD-OCT
Time frame: At study visit (Day 1)
Cohorts A and B: Tenon's Capsule Thickness Measured Using SD-OCT
Time frame: At study visit (Day 1)
Cohorts A and B: Sum of Conjunctival and Tenon's Capsule Measured Using SD-OCT
Time frame: At study visit (Day 1)
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)
1 secondary outcome
Cohort A: Previous Intravitreal (IVT) Injections (Yes/No)
Time frame: At study visit (Day 1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neovascular Age-related Macular Degeneration and Diabetic Macular Edema, run by Hoffmann-La Roche at 20 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohorts A and B: Conjunctival Thickness Measured Using SD-OCT (time frame: At study visit (Day 1)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.