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 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 12:33 AM
NCT ID:
NCT00460967
Eligibility Criteria:
Inclusion Criteria:
* Study eye must have a diagnosis of non-exudative, "Dry", AMD with equivalent drusen surface area of approximately 31,000 µm2 \[e.g. at least 10 soft, semi-soft intermediate size ≥63µm or at least 3 drusen size ≥125 µm within 3,000 µm of the fovea documented on macular exam, retinal angiography and fundus photographs as determined by the reading center. ETDRS BCVA of 20/40 - 20/100 inclusive
Exclusion Criteria:
* Either eye with previous or active sub-retinal neovascularization (SRNV) or choroidal neovascularization (CNV)
* Pigment epithelial detachment (PED) within 500 µm of the fovea
* Either eye with a diagnosis of exudative (wet) AMD
* Subjects having undergone cataract surgery less than 3 months prior to enrollment without an open posterior capsule
* Uncontrolled hypertension and/or diabetes
* Subjects with prolonged PT/PTT (unless the subject is taking warfarin), hematocrit \<35%, evidence of active bleeding, platelet count \<100,000/ml
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
85 Years
Study:
NCT00460967
Study Brief:
Protocol Section:
NCT00460967