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:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
NCT ID:
NCT04782128
Eligibility Criteria:
Inclusion Criteria:
* Sign the consent form, willing and able to comply with clinic visits and study-related procedures;
* Aged 18 years to 80 years, male or female;
* Diabetes mellitus(type 1 or 2);
* Moderately severe to severe NPDR (DRSS levels 47 or 53) which was confirmed by the central reading center, and in whom PRP can be safely deferred by the investigator's judgement;
* BCVA score in the study eye of ≥69 letters (approximate Snellen equivalent of 20/40 or better) using the ETDRS protocol at an initial testing distance of 4 meters;
* If both eyes meet the inclusion criterion, one eye with poor BCVA is selected as the study eye;
Exclusion Criteria:
* Presence of DME threatening the center of the macula (within 1,000 microns of the foveal center) in the study eye;
* Evidence of retinal neovascularization on clinical examination or FA;
* Any prior focal or grid laser photocoagulation (within 1,000 microns of the foveal center) or PRP in the study eye;
* Current ASNV, vitreous hemorrhage, tractional retinal detachment or epiretinal membrane involved the macular in the study eye;
* History of vitreoretinal surgery in the study eye;
* Active infectious blepharitis, keratitis, scleritis, conjunctivitis at the screening assessments in either eye ;
* Previous treatment with anti-angiogenic drugs in either eye or system (ranibizumab, aflibercept, conbercept, etc) within 3 months of the Day 0 visit;
* Previous use of intraocular or periocular corticosteroids (such as triamcinolone acetonide, dexamethasone vitreous implant) in either eye within 6 months of day 0.
* Uncontrolled clinical disease (such as severe psychiatric, neurological, cardiovascular, respiratory disease or other systemic diseases) and tumors;
* Pregnant or lactating women, subjects who had family planning throughout the study period;
* Those who participated in clinical trials for 3 months or 5 half-lives of the investigational product (the longer the time) before theDay 0
* Those who considered unsuitable for enrollment by investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04782128
Study Brief:
Protocol Section:
NCT04782128