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 @ 11:30 PM
Ignite Modification Date:
2025-12-24 @ 11:30 PM
NCT ID:
NCT03904056
Eligibility Criteria:
Inclusion Criteria:
* adult patients with treatment-naive PDR and a best-corrected visual acuity (BCVA) better than 20/800
Exclusion Criteria:
* Presence of advanced PDR, i.e., vitreous hemorrhage that would prevent documentation of the fundoscopic examination or administration of PRP, or presence of traction retinal detachment;
* presence of ring-shaped retinal neovascularization extending along both temporal arcades and the optic disc;
* an abnormality of the vitreoretinal interface in the macular region that would lead the investigator to consider the necessity of pars plana vitrectomy;
* intravitreal injection of corticosteroids or other antiangiogenic drugs during the prior 6 months;
* inability of patient to fixate and perform reliable automated static perimetry;
* cataract surgery during the prior 3 months;
* history of pars plana vitrectomy or scleral buckle;
* acute ocular infection;
* allergy to fluorescein;
* medical or psychological conditions that would prevent the patient from giving written informed consent or completing the study;
* significant uncontrolled disease that, in the opinion of the investigator, would prevent the patient from completing the study;
* participation in another clinical study during the previous 30 days.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03904056
Study Brief:
Protocol Section:
NCT03904056