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)

Roche

Status: Completed

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

Study type: Observational

Funder types: Industry

Identifiers

NCT06723288

MR45734

Details and patient eligibility

About

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.

Enrollment: 736 patients

Sex: All

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

736 participants in 2 patient groups

Cohort A: nAMD/DME Participants

Description:

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. Additionally, swept source optical coherence tomography (SS-OCT) will be performed on the first 50 participants.

Cohort B: Healthy Subjects

Description:

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. Additionally, SS-OCT will be performed on the first 50 healthy subjects.