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 @ 4:45 PM
Ignite Modification Date:
2025-12-24 @ 4:45 PM
NCT ID:
NCT04698850
Eligibility Criteria:
Inclusion Criteria:
* age of 50 years or more at the time the informed consent is signed
* active RAP in the macula including fovea diagnosed on OCT and OCTA
* BCVA between 70 to 35 ETDRS letters (approx. 20/40 to 20/200 Snellen equivalent)
* decrease in BCVA caused primarily by the RAP in the study eye
* presence of intra- or subretinal fluid or PED in the central 1 mm of the macula on the OCT
* patient capable of signing the informed consent
Exclusion Criteria:
* other causes of choroidal neovascular membrane (CNV) than wAMD
* previous or current conditions of the study eye:
1. subretinal haemorrhage comprising more than 25% of the lesion in the study eye
2. scar or fibrosis comprising more than 50% of the lesion in the study eye
3. presence of retinal pigment epithelium (RPE) tears or ruptures in the central 1 mm of the macula in the study eye
4. total lesion size more than 8 papillary diameters (PD) as per OCT and FP examination
5. uncontrolled glaucoma in the study eye defined as IOP of more than 25 mmHg despite the antiglaucoma treatment
6. idiopathic or autoimmune uveitis in the study eye
7. other pathologies in the macula of the study eye which can be expected to influence the BCVA (e.g. macular hole, retinal atrophy, epiretinal membrane, etc.)
8. history of glaucoma surgery in the study eye or probability that it will be necessary in the future
9. aphakia or pseudophakia with absence of the posterior lens capsule (with the exception of missing posterior capsule due to Nd:YAG laser capsulotomy) in the study eye
10. myopia in the study eye with spherical equivalent of more than 8 dioptries before any refractive or cataract surgery
11. significant opacities of the ocular media in the study eye including cataract, which can interfere with BCVA assessment or FP or OCT examination
12. corneal transplantation or corneal dystrophy in the study eye
13. irregular astigmatism or BCVA-lowering amblyopia in the study eye
14. diabetic retinopathy, diabetic macular edema or any other retinal vascular disease in the study eye
15. extraocular or periocular infection or inflammation (e.g. blepharitis, keratitis, conjunctivitis, scleritis, etc.) in any eye at the time of screening or baseline visit
16. any intraocular infection or inflammation in any eye during 12 weeks (84 days) before the screening visit
17. allergy or hypersensitivity to any component contained in the study drug
18. pregnant or breastfeeding women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT04698850
Study Brief:
Protocol Section:
NCT04698850