Description:

ODM derived from http://clinicaltrials.gov/show/NCT00637377

Link:

http://clinicaltrials.gov/show/NCT00637377

Keywords:
Versions (3) ▾
  1. 12/9/13
  2. 4/3/14
  3. 4/15/14
Uploaded on:

April 15, 2014

DOI:
No DOI assigned. To request one pleaselog in.
License:
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00637377 Macular Degeneration

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
age at least 50 Years
Signed informed consent.
Men and women >/=50 years of age.
Active primary or recurrent subfoveal CNV lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye.
ETDRS best-corrected visual acuity of: 20/40 to 20/320 (letter score of 73 to 25) in the study eye at 4 meters.
Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures.
informed consent
Exclusion Criteria
Any prior ocular (in the study eye) or systemic treatment or surgery for neovascular AMD, except dietary supplements or vitamins.
Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye.
Any prior treatment with anti-VEGF agents in the study eye.
Total lesion size >12 disc areas (30.5 mm, including blood, scars and neovascularization) as assessed by FA in the study eye.
Subretinal hemorrhages that is either 50% or more of the total lesion area, or if the blood is under the fovea and is 1 or more disc areas in size in the study eye (if the blood is under the fovea, then the fovea must be surrounded by 270 degrees by visible CNV).
Scar or fibrosis making up >50% of the total lesion in the study eye.
Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.
History of any vitreous hemorrhage within 4 weeks prior to Visit 1 in the study eye.
Presence of other causes of CNV in the study eye.
Prior vitrectomy in the study eye.
History of retinal detachment or treatment or surgery for retinal detachment in the study eye.
Any history of macular hole of stage 2 and above in the study eye.
Any intraocular or periocular surgery within 3 months of Day 1 on the study eye, except lid surgery, which may not have taken place within 1 month of Day 1, as long as it is unlikely to interfere with the injection.
History or clinical evidence of diabetic retinopathy, diabetic macular edema or any retinal vascular disease other than AMD in either eye.