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 @ 1:01 AM
Ignite Modification Date:
2025-12-25 @ 1:01 AM
NCT ID:
NCT00574093
Eligibility Criteria:
Inclusion Criteria:
* 50 years or older male or female patients of any race with subfoveal CNV secondary to AMD (all types of lesion).
* The total area of CNV encompassed within the lesion must be \>50% of the total lesion area. The total lesion area must have the greatest linear dimension ≤5400 microns (9 MPS Disc Areas).
* BCVA letter score in the study eye should be between 73 and 24 (approximately 20/40 to 20/320 Snellen Equivalent) using an ETDRS chart measured at 4 meters distance.
Exclusion Criteria:
* Any prior treatments with Visudyne, Macugen, Lucentis (Ranibizumab), Avastin (Bevacizumab) or other anti-angiogenic or corticosteroid intravitreal treatment in the study eye
* Prior external-beam radiation, subfoveal focal laser photocoagulation, transpupillary thermotherapy, pars plana vitrectomy in the study eye
* History of intraocular surgery in the study eye except for uncomplicated cataract surgery more than 90 days prior to treatment
* History of YAG-laser posterior capsulotomy in the study eye within 30 days prior treatment
* Use of non steroid antinflammatory drugs during the study
* Presence of angioid streaks, presumed ocular histoplasmosis syndrome, pathologic myopia (\>8 D)
* Presence of fibrosis, haemorrhage, pigment epithelial detachments or other hypofluorescent lesions obscuring greater than 50% of the CNV lesion
* Tear (rip) of the retinal pigment epithelium
* Vitreal haemorrhage, retinal detachment or macular hole
* Epiretinal membrane
* Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with two or more topical pharmacological antiglaucomatous medication)
* Active or history of ocular inflammation or infection
* Aphakia and posterior capsule tear
* Pregnant or nursing (lactating) women
* Women of child-bearing potential unless they meet the following definition of postmenopausal
* Any systemic medical condition that may interferes with the safety of the patient
* Positive anamnesis for tumor in last the 5 years
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
95 Years
Study:
NCT00574093
Study Brief:
Protocol Section:
NCT00574093