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 @ 5:50 PM
Ignite Modification Date:
2025-12-24 @ 5:50 PM
NCT ID:
NCT01543568
Eligibility Criteria:
Inclusion Criteria:
* Ability to provide written informed consent and comply with study assessments for the full duration of the study
* Age \> 50 years
* Choroidal neovascularization secondary to AMD
* History of treatment with 0.5mg ranibizumab followed by 2.0mg ranibizumab for AMD
* Best corrected visual acuity in the study eye between 20/20 to 20/400 using an ETDRS chart
Exclusion Criteria:
* Pregnancy (positive pregnancy test) or lactation
* Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
* Participation in another simultaneous medical investigation or trial
* Prior treatment with anti-VEGF therapy in the study eye within 28 days of baseline
* Prior treatment with PDT within the past 3 months or more than 4 prior PDT treatments.
* Presence of significant subfoveal fibrosis or atrophy.
* Prior treatment with intravitreal aflibercept injection
* Prior treatment with triamcinolone in the study eye within 6 months of BSL.
* Prior treatment with dexamethasone in the study eye within 30 days prior to BSL
* Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding Baseline
* History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye
* Active intraocular inflammation (grade trace or above) in the study eye
* Current vitreous hemorrhage in the study eye
* History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
* Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
* Uncontrolled glaucoma in the study eye (defined as IOP ≥ 30 mmHg despite treatment with anti-glaucoma medication)
* History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 3 months of study enrollment.
* History of allergy to fluorescein, ICG or iodine, not amenable to treatment
* History of retinal pigment epithelial tear or rip
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT01543568
Study Brief:
Protocol Section:
NCT01543568