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:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-24 @ 9:56 PM
NCT ID:
NCT03922932
Eligibility Criteria:
Participant-Related Inclusion Criteria:
I. All Diabetics (Groups A, B, C)
* Type 1 diabetes of at least 5 years duration or
* Type 2 diabetes of any duration II. Group B
* Able to return for follow-up over 3 years
Participant-Related Exclusion Criteria:
I. Group B
* Significant medical condition that would make long-term follow-up difficult II. Controls (Group D)
* Any medical problems associated with retinal vascular abnormalities (i.e., hypertension, systemic vasculitis, carotid insufficiency, etc.)
Eye-Related Inclusion Criteria:
I. Group A:
* Presence of active neovascularization, with or without prior treatment
* Presence of involuted fibrovascular proliferans
II. Group B:
* NPDR of any severity as defined by the International Clinical Diabetic Retinopathy Severity Scale
III. Groups C \& D:
* No evidence of diabetic retinopathy
IV. Group ME:
* Presence of center-involving macular edema requiring treatment
Eye-Related Exclusion Criteria: (Applies to study eye only. May be present in non-study eye.)
* Visual acuity worse than 20/200
* Inability to maintain stable fixation for OCT imaging
* History of major eye surgery (vitrectomy, cataract surgery, scleral buckle, other intraocular surgery, etc.) within 90 days of enrollment
* History of another eye disease or condition that may alter retinal perfusion, permeability, or retinal anatomy
* Substantial media opacity (cataract, corneal scar, vitreous hemorrhage) that may interfere with study imaging
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03922932
Study Brief:
Protocol Section:
NCT03922932