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 @ 11:07 PM
Ignite Modification Date:
2025-12-24 @ 11:07 PM
NCT ID:
NCT05345769
Eligibility Criteria:
Inclusion Criteria:
1. Male or female subjects with 50 years of age or older
2. Active sub-foveal CNV lesion secondary to nAMD including juxta or extra-foveal lesions that partially affect the fovea
3. The area of CNV must occupy at least 50% of total lesion
4. Total lesion area ≤ 12 DA
5. ETDRS BCVA letter score measured at screening and baseline
6. Clear ocular media and adequate pupil dilation to permit good quality photographic imaging in study eye
Exclusion Criteria:
1. Any previous systemic anti-VEGF treatment
2. Any systemic treatment or therapy to treat neovascular AMD
3. Continuous use of systemic corticosteroids
4. Diseases that affect intravenous injection and venous blood sampling
5. Presence of CNV due to other causes, such as ocular histoplasmosis, trauma, multifocal choroiditis, angioid streaks, history of choroidal rupture, or pathologic myopia in study eye
6. History or any concurrent ocular condition which, in opinion of investigator, could either confound interpretation of efficacy and safety of IP or require medical or surgical intervention.
7. The area of fibrosis occupies ≥ 50% of total lesion area in study eye
8. Evidence of myopia degeneration, diagnosis supported by the axial length examination in study eye
9. History or any concurrent macular abnormality other than AMD in study eye
10. Current vitreous hemorrhage or history of vitreous hemorrhage in study eye
11. History of recurrent inflammation in study eye
12. History of treatment for nAMD
13. Subject having out of range laboratory values defined as:
ALT or AST \> 2 x ULN, total bilirubin \> 1.5 x ULN Serum creatinine \> 1.5 x ULN, BUN \> 2 x ULN HbA1c \> 7.5% at screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT05345769
Study Brief:
Protocol Section:
NCT05345769