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 @ 12:09 AM
Ignite Modification Date:
2025-12-25 @ 12:09 AM
NCT ID:
NCT02860858
Eligibility Criteria:
Inclusion Criteria:
* Male or Female \>/= 18 years
* Confirmed diagnosis of symptomatic macular PCV in the study eye defined by: - Active macular polypoidal lesions shown by ICGA and - Presence of serosanguinous maculopathy
* BCVA letter score between 78-24 using ETDRS visual acuity chart measured at 4 meters
Exclusion Criteria:
* Previous treatment with systemic anti-VEGF drugs within 6 months prior to Baseline (e.g., sorafenib \[Nexavar®\], sunitinib \[Sutent®\], bevacizumab \[Avastin®\])
Study eye:
* Active ocular inflammation or infection (ocular or periocular)
* Uncontrolled intraocular hypertension or glaucoma (IOP\> 30 mmPIg) despite treatment with anti-glaucoma medication
* Predominantly-scarred PCV lesions
* Ocular disorders in the study eye (e.g. cataract, retinal vascular occlusion, diabetic retinopathy) that, in the opinion of the investigator may confound interpretation of study results or compromise VA or require medical or surgical intervention during the study period
* Prior treatment with verteporfin PDT, external-beam radiation, subfoveal or extrafoveal focal laser photocoagulation, submacular surgery, or transpupillary thermotherapy
* Prior treatment with any anti-VEGF compound or any investigational treatment
* Treatment with intravitreal or subtenon corticosteroid injection or device implantation within 90 days
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02860858
Study Brief:
Protocol Section:
NCT02860858