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 @ 4:51 PM
Ignite Modification Date:
2025-12-24 @ 4:51 PM
NCT ID:
NCT04567550
Eligibility Criteria:
Part 1 (DR without CI-DME):
Inclusion Criteria:
* Patients 25-89 years of age with a diabetic retinopathy (DR) diagnosis of nonproliferative diabetic retinopathy (NPDR) and proliferative diabetic retinopathy (PDR) secondary to diabetes mellitus Type 1 or 2 for which PRP or anti-VEGF injections can be safely deferred for at least 6 months
* HbA1c \< 12%.
* Best corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score in the study eye of ≥69 letters (approximate Snellen equivalent of 20/40 or better).
* Prior history of CI-DME in the study eye is acceptable.
* Must be willing and able to provide written, signed informed consent.
Exclusion Criteria:
* Neovascularization in the study eye from a cause other than DR.
* Presence of any active CI-DME.
* Active or history of retinal detachment in the study eye.
* Any evidence or documented history of PRP or retinal laser in the study eye.
* Patients who had a prior vitrectomy surgery.
* Women of childbearing potential.
Part 2 (DR with CI-DME):
Inclusion Criteria:
* Patients 25-89 years of age with diabetic retinopathy secondary to diabetes mellitus Type 1 or 2.
* HbA1c \< 12%
* Macular thickening secondary to DME involving the center of the fovea, CST on SD-OCT (≥ 325 μm)
* Best corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score in the study eye of 78-25 letters (approximate Snellen equivalent of 20/32 to 20/320)
* Participants must have demonstrated a meaningful response to anti-VEGF therapy.
* Must be willing and able to provide written, signed informed consent
Exclusion Criteria:
* Neovascularization in the study eye from a cause other than DR.
* Active or history of retinal detachment in the study eye.
* Any evidence or documented history of PRP or retinal laser in the study eye.
* Patients who had a prior vitrectomy surgery.
* Women of childbearing potential.
Note: Other inclusions/exclusions criteria apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
89 Years
Study:
NCT04567550
Study Brief:
Protocol Section:
NCT04567550