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 @ 1:08 AM
Ignite Modification Date:
2025-12-25 @ 1:08 AM
NCT ID:
NCT03669393
Eligibility Criteria:
Inclusion Criteria:
* Male or female aged 18 years or older
* Macular oedema caused by MacTel 1, with CST \>300µm on SD-OCT
* Written informed consent obtained from the subject prior to screening procedures
Exclusion Criteria:
* Type 1 or type 2 Diabetes Mellitus
* Concurrent disease in the study eye that could require medical or surgical intervention during the study period for up to 30 days after the last study treatment, or could confound interpretation of the results
* Previous confounding treatments / procedures, or their planned / expected use during the study period for up to 30 days after the last administration of study treatment
* Any active ocular / intraocular infection or inflammation in either eye
* Pregnant or lactating female, or female of child-bearing potential not utilising an adequate form of contraception, or male of reproductive potential not utilising contraception
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03669393
Study Brief:
Protocol Section:
NCT03669393