Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
Age
50–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Signed informed consent
Age \>=50 years
Eligibility for treatment with PDT using verteporfin in the study eye according to the Visudyne product labeling
Future treatment with PDT using verteporfin anticipated or expected in the study eye
Primary or recurrent subfoveal choroidal neovascularization (CNV) lesions secondary to age-related macular degeneration (AMD) in the study eye
A classic CNV component (well-demarcated hyperfluorescence boundaries in the early phase of the fluorescein angiogram) that is \>=50% of the total lesion size
Total lesion size of less than or equal to 5400 um in greatest linear dimension (GLD)
Best corrected visual acuity, using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts, of 20/40 to 20/320 (Snellen equivalent) in the study eye
You may not be if
Prior treatment with verteporfin, external-beam radiation therapy, or transpupillary thermotherapy (TTT) in the study eye
Treatment with verteporfin in the non-study eye less than 7 days preceding Day 0
Previous participation in a clinical trial (for either eye) involving anti angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.)
Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye
Previous subfoveal focal laser photocoagulation in the study eye
Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding Day 0
History of vitrectomy surgery in the study eye
History of submacular surgery or other surgical intervention for AMD in the study eye
Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals)
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 (DA) in size
Subfoveal fibrosis or atrophy in the study eye
CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia
Retinal pigment epithelial tear involving the macula in the study eye
Any concurrent intraocular condition in the study eye (e.g., cataract or diabetic retinopathy) that, in the opinion of the Investigator could either: (1) Require medical or surgical intervention during the 24-month study period to prevent or treat visual loss that might result from that condition, or (2) If allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of best corrected visual acuity over the 24-month study period
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
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 -8 diopters of myopia
Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding Day 0
Uncontrolled glaucoma in the study eye (defined as intraocular pressure \>=30 mmHg despite treatment with anti-glaucoma medication)
History of glaucoma filtering surgery in the study eye
History of corneal transplant in the study eye
Premenopausal women not using adequate contraception
History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications
Current treatment for active systemic infection
History of allergy to fluorescein, not amenable to treatment
Inability to obtain fundus photographs or fluorescein angiograms of sufficient quality to be analyzed and graded by the central reading center
Inability to comply with study or follow up procedures
