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:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT03490318
Eligibility Criteria:
Inclusion Criteria:
* Adults (18 years of age or older) with type 1 or 2 diabetes with previously successfully treated DMO and/or PDR in one or both eyes and in whom, at the time of enrolment in the study, DMO and/or PDR may be active or inactive.
* Active DMO will be defined as a central subfield retinal thickness (CRT) of \> 300 microns and/or presence of intraretinal/subretinal fluid on spectral domain OCT.
* Inactive DMO will be defined as no intraretinal/subretinal fluid
* Active PDR will be defined by the presence of sub-hyaloid/vitreous haemorrhage and/or active new vessels (new vessels with lack of fibrosis on them)
* Inactive PDR will be defined by the lack of preretinal/vitreous haemorrhage and lack of active new vessels.
Exclusion Criteria:
* Unable to provide informed consent
* Patients do not read, speak or understand English
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03490318
Study Brief:
Protocol Section:
NCT03490318