Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:18 PM
Ignite Modification Date:
2025-12-26 @ 10:18 PM
NCT ID:
NCT03765112
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 Participants can have 1 or 2 study eyes
Patient Group:
* Diabetes mellitus type 1 or 2
* Study eye with any DR severity level: no DR, mild NPDR, mod NPDR, sev NPDR, PDR
Exclusion Criteria:
* Substantial media opacities that would preclude successful imaging
* Active intraocular inflammation (grade trace or above) in either eye like infectious conjunctivitis, keratitis, scleritis, endophthalmitis as well as idiopathic or autoimmune-associated uveitis in either eye
* Structural damage to the center of macula in the study eye
* History of prior panretinal photocoagulation
* History of treatment with intravitreal agents over the prior 6 months
* Macular edema involving the central subfield
* Prior history of vitrectomy
* Atrophy of retinal pigment epithelium, subretinal fibrosis, laser scar within foveal avascular zone (FAZ) or organized hard exudate plaques
* Substantial non-diabetic intraocular pathology in the study eye including retinal vascular occlusion, retinal detachment, macular hole, choroidal neovascularization, macula dystrophies
* Intraocular surgery (including cataract surgery, YAG laser capsulotomy) in the study eye within 3 months preceding Day 0, or history of corneal transplantation in the study eye
* Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma medication)or history of glaucoma filtration surgery
* Inability to obtain fundus images of sufficient quality to be analyzed and graded
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03765112
Study Brief:
Protocol Section:
NCT03765112