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)

Not yet recruiting

• Conditions: Neovascular Age-related Macular Degeneration; Diabetic Macular Edema

• Registration Number: NCT06723288
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-04
• Study First Submitted QC: 2024-12-04
• Last Update Submitted: 2024-12-04
• Study Start: 2024-12-09
• Study First Posted: 2024-12-09
• Last Update Posted: 2024-12-09
• Primary Completion: 2025-06-16
• Study Completion: 2025-06-16

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 854

Inclusion Criteria

For nAMD/DME participants:

• Diagnosis of nAMD/DME

For Healthy Subjects:

• Mean intraocular pressure (IOP) lower than 18 millimeters of mercury (mmHg)
• Normal visual function

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Exclusion Criteria

• Dry eye disease except those treated only with artificial tears
• Ocular hypertension treated with hypotensive drugs
• Pterygium
• Strabismus
• Previous ocular surgery except 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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cohorts A and B: Number of Participants in Age Groups 45-54, 55-64, 65-74, >=75	At study visit (Day 1)
Cohorts A and B: Conjunctival Epithelium Thickness Measured Using SD-OCT	At study visit (Day 1)
Cohorts A and B: Conjunctival Stroma 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 Epithelium Thickness, Conjunctival stroma and Tenon's Capsule Measured Using SD-OCT	At study visit (Day 1)

Secondary Outcome Measures

Name	Time	Method
Cohort A: Previous Intravitreal (IVT) Injections (Yes/No)	At study visit (Day 1)
Cohorts A and B: Conjunctival Epithelium Thickness Measured Using SS-OCT	At study visit (Day 1)
Cohorts A and B: Conjunctival Stroma Thickness Measured Using SS-OCT	At study visit (Day 1)
Cohorts A and B: Tenon's Capsule Thickness Measured Using SS-OCT	At study visit (Day 1)
Cohorts A and B: Sum of Conjunctival Epithelium Thickness, Conjunctival stroma and Tenon's Capsule Measured Using SS-OCT	At study visit (Day 1)
Cohorts A and B: Scleral Thickness Measured Using SS-OCT	At study visit (Day 1)