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 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 1:20 AM
NCT ID:
NCT01304693
Eligibility Criteria:
Inclusion Criteria:
* Provide written informed consent.
* Primary subfoveal choroidal neovascularization (CNV) secondary to AMD, including predominantly classic, minimally classic or occult lesions, in the study eye.
* New diagnosis of wet AMD or evidence of recent disease progression within the last 3 months in study eye.
* Evidence of subretinal fluid or retinal cystic changes with a CSFT of \> 340 μm using a Spectralis SD-OCT (Heidelberg Engineering) imaging system.
* Best-corrected visual acuity (BCVA) of Snellen equivalent 20/200 or better in the non-study eye.
* Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
* Previously administered therapy, approved or investigational, for wet AMD in the study eye.
* Any current or history of macular or retinal disease in the stuy eye other than wet AMD.
* Lasik or cataract surgery within the last 3 months in the study eye or expected to have cataract removal surgery during the study.
* Uncontrolled or advanced glaucoma in the study eye.
* Use of systemic or topical ocular corticosteroids.
* History of a medical condition that, in the opinion of the Investigator, would preclude scheduled visits, completion of the study, or safe administration of study medication.
* Abnormal or unsuitable laboratory results at Screening visit.
* Lactating or pregnant. Women of childbearing potential must use adequate birth control for the duration of the study.
* Other protocol-defined exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT01304693
Study Brief:
Protocol Section:
NCT01304693