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 @ 11:13 PM
Ignite Modification Date:
2025-12-24 @ 11:13 PM
NCT ID:
NCT04847869
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis macular edema secondary to branch or central vein occlusion (BRVO or CRVO)
* CMT of \>300 µm and less than 550 µm;
* Best corrected visual acuity of 6/6 to 6/24 (letters 87 - 53);
* Intraocular pressure \< 25 mmHg;
* Written informed consent has been obtained.
Exclusion Criteria:
* Loss of vision due to other causes (e.g. age-related macular degeneration, myopic macular degeneration, DME);
* Known allergy to agents used in the study e.g. fluorescein;
* Women who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using reliable means of contraception;
* Only eye (vision in other eye \<6/60);
* Study eye is an amblyopic eye;
* Macular oedema due to other causes;
* Significant diabetic retinopathy;
* An ocular condition that would prevent visual acuity improvement despite resolution of oedema (such as foveal atrophy or substantial premacular fibrosis;
* Previous treatment with any anti-VEGF therapy or investigational drugs in the study eye at any time prior to baseline.
* Previous use of intraocular or periocular steroids in study eye at any time prior to baseline;
* Cataract surgery within the last 3 months;
* Retinal laser treatment within the last 6 months;
* Media opacity including cataract that already precludes adequate macular photography or cataract that is likely to require surgery within 6 months;
* Intercurrent severe disease such as septicaemia, any condition which would affect follow-up;
* History of chronic renal failure requiring dialysis or renal transplant;
* Blood pressure \>180/120;
* Participant has a condition or is in a situation that in the investigator's opinion may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04847869
Study Brief:
Protocol Section:
NCT04847869