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 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT06683950
Eligibility Criteria:
Inclusion Criteria:
* Willing, committed, and able to return for ALL clinic visits and complete all study related procedures.
* Able to read, (or, if unable to read due to visual impairment, be read to verbatim by the person administering the informed consent or a family member) understand and willing to sign the informed consent form.
* Signed informed consent
* Patients aged 50 years or older
* Patients diagnosed with neovascular AMD or PCV
* Patients underwent faricimab or aflibercept 2mg injections with an inverval of 4 to 16 weeks
* Patients who continued to show persistent subretinal fluid (SRF) or intraretinal fluid (IRF) despite receiving two consecutive faricimab or aflibercept 2mg injections at the same injection interval.
* In cases where the central retinal thickness did not decrease by more than 50 μm during two consecutive treatments prior to inclusion in the study
* ETDRS BCVA letter score ≥25 letters (approximately 20/320 or better) in the study eye
Exclusion Criteria:
* Any prior ocular (in the study eye) or systemic treatment or surgery for neovascular AMD except dietary supplements or vitamins.
* Significant media opacities, including cataract, in the study eye that might interfere with visual acuity, assessment of safety, or fundus photography.
* Any concurrent ocular condition in the study eye which, in the opinion of the investigator, could either increase the risk to the patient beyond what is to be expected from standard procedures of intraocular injection, or which otherwise may interfere with the injection procedure or with evaluation of efficacy or safety.
* Any ocular or periocular infection within the last 2 weeks prior to Screening in either eye.
* Any history of uveitis in either eye.
* Presence of definite chorioretional anastomosis
* Scar or fibrosis, making up \> 50% of total lesion in the study eye.
* Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
* Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.
* History or clinical evidence of diabetic retinopathy, diabetic macular edema or any other vascular disease affecting the retina, other than AMD, in either eye.
* Any concurrent intraocular condition in the study eye (e.g. cataract) that, in the opinion of the investigator, could require either medical or surgical intervention during the 76 week study period.
* Prior vitrectomy in the study eye
* Any history of macular hole of stage 2 and above in the study eye.
* Any intraocular or periocular surgery within 3 months of Day 1 on the study eye, except lid surgery, which may not have taken place within 1 month of day 1, as long as its unlikely to interfere with the injection.
* Prior trabeculectomy or other filtration surgery in the study eye.
* Uncontrolled glaucoma (defined as intraocular pressure ≥ 25 mmHg despite treatment with antiglaucoma medication) in the study eye.
* Active intraocular inflammation in either eye.
* Active ocular or periocular infection in either eye.
* Aphakia or pseudophakia with absence of posterior capsule (unless it occurred as a result of a yttrium aluminum garnet \[YAG\] posterior capsulotomy) in the study eye.
* History of corneal transplant or corneal dystrophy in the study eye.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT06683950
Study Brief:
Protocol Section:
NCT06683950