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 @ 11:35 PM
Ignite Modification Date:
2025-12-24 @ 11:35 PM
NCT ID:
NCT01021956
Eligibility Criteria:
Inclusion Criteria:
* Twenty eight days or more after at least one ranibizumab injection, recurrent leakage on Fluorescein Angiography (FA) from subfoveal Choroidal NeoVessels (CNV) secondary to AMD.
* Total lesion size not exceeding 5400 μm in its greatest linear dimension.
* Best Corrected Visual Acuity (BCVA) letter score of 73 to 23 in the study eye at a starting distance of 4 meters.
* No contraindication to intravitreal ranibizumab injection.
* Postmenopausal for at least 12 months prior to enrollment or practicing medically acceptable form of birth control and not pregnant. Male subjects must be practicing a medically acceptable form of birth control.
Exclusion Criteria:
* Prior treatments:
* Previous subfoveal laser photocoagulation, external-beam radiation therapy, or transpupillary thermoTherapy (TTT) in the study eye at any time.
* Using anti-VEGF therapies for other indications (e.g., cancer) in the 30 days prior to the study and/or during the study
* Received anti-VEGF injection in study eye during less than 28 days prior to Day 1 of the study.
* More than three previous photodynamic therapy (PDT) treatments in the preceding 12 months.
* Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within the preceding month.
* History of vitrectomy,of glaucoma filtering surgery,submacular surgery or other surgical intervention in the study eye.
* History of corneal transplant in the study eye.
* Previous participation in any studies of investigational drugs within 1 month preceding Day 1 (excluding vitamins and minerals).
* Lesion Characteristics
* Permanent structural damage to the center of the fovea of the study eye, or a concurrent ocular or systemic condition that could contraindicate administration of an investigational drug, or render the subject at a high risk of treatment complications.
* Subretinal hemorrhage in the study eye that involves the center of the fovea, if the size of the hemorrhage is either ≥50% of the total lesion area or ≥1 disc area in size.
* Subfoveal fibrosis or atrophy in the study eye which is at least 50% of the lesion.
* CNV in either eye due to other causes.
* Retinal pigment epithelial tear involving the macula in the study eye.
* Concurrent Ocular Conditions
* Active intraocular inflammation (grade trace or above) or current vitreous hemorrhage or rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye.
* History of idiopathic or autoimmune-associated uveitis in either eye.
* Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye.
* Aphakia or absence of the posterior capsule in the study eye.
* Spherical equivalent of the refractive error in the study eye demonstrating more-than eight diopters of myopia.
* Intraocular surgery (including cataract surgery) in the study eye within three months preceding Day 1.
* Uncontrolled glaucoma in the study eye.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT01021956
Study Brief:
Protocol Section:
NCT01021956