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 @ 1:53 PM
Ignite Modification Date:
2025-12-24 @ 1:53 PM
NCT ID:
NCT01023295
Eligibility Criteria:
Inclusion Criteria
* Male or female age ≥21 years.
* Asian race (e.g. Chinese, Japanese, Korean, Thai).
* Polypoidal choroidal vasculopathy in the study eye
* Presence of ≥ 1 visible polypoidal varicosity on ICGA.
* Presence of a measurable branching vascular network
* BCVA by ETDRS of 68 to 4 letters in the study eye.
Ophthalmologic Exclusion Criteria
* Prior treatment with intravitreal or systemic anti-VEGF therapy within 60 days of enrollment.
* Any other prior treatment for PCV including thermal laser photocoagulation, photodynamic therapy (i.e., verteporfin), or any investigational therapies.
* Any history of prior retinal or subretinal surgery, transpupillary thermography, radiation, implantation of intravitreal drug delivery device, vitrectomy.
* Any other intraocular surgery or laser treatment within 90 days or any surgeries planned during the study period.
* Fibrosis involving ≥50% of the total lesion.
* Presence of hemorrhage which potentially obscures \>75% of vascular pathology to be assessed by imaging procedures.
* Retinal or choroidal vascular disease in study eye due to causes other than PCV, such as uveitis, trauma, or pathologic myopia.
* Macular edema in either eye due to other causes, such as diabetic retinopathy.
* Evidence of glaucomatous eye disease, glaucomatous visual field loss.
* History of allergy to fluorescein or ICG dye.
Medical Exclusion Criteria
* Current or history within two years of any significant heart disease.
* Uncontrolled hypertension.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT01023295
Study Brief:
Protocol Section:
NCT01023295