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 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT04067856
Eligibility Criteria:
Inclusion Criteria:
* Age greater than 18 years old with type one or type two diabetes mellitus
* Center-involving diabetic macular edema with central subfield thickness ≥ 320um on Heidelberg Spectralis optical coherence tomography (OCT) testing
* Best-corrected electron-early treatment diabetic retinopathy study (E-ETDRS Visual Acuity) visual acuity letter score between 78 to 24
* Any Lens Opacities Classification System (LOCS) III cataract grade greater than or equal to two
Exclusion Criteria:
* Presence of macular edema attributable to other causes including but not limited to retinal venous occlusive disease and non-infectious uveitis
* History of glaucoma
* History of steroid-induced intraocular pressure (IOP) elevation that required IOP-lowering treatment
* Optic nerve cup to disc ratio greater than 0.6
* Active proliferative diabetic retinopathy
* Presence of other retinal diseases including but not limited to age-related macular degeneration, retinal venous occlusive disease and posterior segment uveitis
* Any prior intraocular surgery
* Treatment with any anti-VEGF medication within the past 3 months or intravitreal steroid within the past 6 months
* Panretinal photocoagulation within the prior 6 months or anticipated need for panretinal photocoagulation within the next 6 months
* IOP greater than or equal to 25
* Systolic blood pressure \> 180 mmHg or diastolic \> 110 mmHg
* Myocardial infarction, other cardiac event requiring hospitalization, cerebrovascular accident, transient ischemic attack or treatment for acute congestive heart failure within the past 6 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
89 Years
Study:
NCT04067856
Study Brief:
Protocol Section:
NCT04067856