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 @ 9:09 PM
Ignite Modification Date:
2025-12-24 @ 9:09 PM
NCT ID:
NCT04387604
Eligibility Criteria:
Inclusion Criteria:
* at least 18 years of age with either type 1 or type 2 diabetes mellitus;
* maximal central subfield foveal thickness (CSF) of at least 300μm (according to SD-OCT images - Spectral Domain Optical Coherence Tomography);
* BCVA of 20 to 80 letters, using ETDRS letters chart;
* ability to provide written informed consent.
Exclusion Criteria:
* Pregnant or lactating;
* Epiretinal membrane (ERM) existence in the study eye;
* persistent posterior hyaloid adherence after vitrectomy for group 2;
* previous vitrectomy for group 1;
* history of other retinal vascular diseases in the study eye;
* LASER photocoagulation or intravitreal injections (IV) of anti-VEGF or systemic anti-VEGF or pro-anti-VEGF treatment and cataract surgery in the 6 months previously to the study eye inclusion;
* IV or peribulbar corticosteroid injections in the 6 months previously to study eye inclusion;
* history of IV of implant of fluocinolone acetonide in the study eye;
* vitreous hemorrhage or opacification in the study eye;
* active proliferative diabetic retinopathy in the study eye;
* active ocular inflammation or infection in either eye;
* aphakia in the study eye;
* other causes for macular edema, for example, after cataract surgery in the study eye;
* other causes of visual loss in the study eye;
* other diseases that may affect the course of macular edema in the study eye;
* uncontrolled glaucoma in either eye (intraocular pressure \> 24 mmHg with treatment);
* history of arterial thrombotic event in the previous 6 months;
* uncontrolled arterial hypertension (systolic blood pressure \>160 mmHg or diastolic blood pressure \> 100 mmHg);
* ward of the state.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04387604
Study Brief:
Protocol Section:
NCT04387604