Please select the eligibility criteria that correspond to the clinical trial below.
Title: Analysis of the Directional Spread of Geographic Atrophy (GA) in Patients With Age-related Macular Degeneration (AMD)
Brief Summary: Age-related macular degeneration (AMD) is the leading cause of irreversible blindness in industrial countries. In the late stages of the disease, neovascular changes or the development of geographic atrophy (GA) may induce severe visual loss. GA is characterized by the development of areas of outer retinal atrophy with continuous spread over time that is corresponded to an visual field defect for the patient. The pathogenesis is still incompletely understood. Despite the break-through in the treatment of neovascular AMD by intravitreally administrated vascular endothelial growths factor (VEGF) inhibitors, there is yet no treatment available to slow down or halt the disease process in GA. We and others have demonstrated that the total GA area progression shows large differences between patients. Potential factors influencing differential progression have been intensely studied: While neither systemic nor genetic factors have been shown to influence GA progression, ocular characteristics such as GA baseline size or phenotypic features of fundus autofluorescence (FAF) abnormalities have been identified as risk characteristics for increased GA progression. While these previous studies have mainly focused on the characterization of total GA area progression, topographic directional spread has not been analyzed and relevant predictive markers are yet unknown. There may be large differences in the local GA progression. The primary objective of this study is to identify specific characteristics, for the local GA progression. The knowledge of such risk factors may help to better understand the pathogenesis of GA. The identification of predictive markers will allow for better prognostic assessment of the individual disease process. The DSGA study is the extension trial of the FAM (Fundus Autofluorescence in Age-related Macular Degeneration) study (NCT00393692).


Options:
A: Inclusion Criteria:

* Signed informed consent
* Age \>=50 years
* Active primary or recurrent subfoveal choroidal neovascularization (CNV) lesions secondary to age-related macular degeneration (AMD) in the study eye
* Lesions with occult CNV or with some classic CNV component are permissible. However, if classic CNV (well-demarcated hyperfluorescence boundaries in the early phase of the fluorescein angiogram) is present, the area of classic CNV must be \<50% of the total lesion size.
* The total area of CNV (including both classic and occult components) encompassed within the lesion must be \>=50% of the total lesion area.
* The total lesion area must be \<=12 disc areas (DA) in size.
* 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

Exclusion Criteria:

* 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 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
B: Inclusion Criteria:

* Multiple sclerosis as diagnosed by the revised 2010 McDonald criteria
* Expanded Disability Status Scale (EDSS) score between 0 and 5.0 at baseline

Exclusion Criteria:

* Primary progressive multiple sclerosis
C: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
D: Inclusion Criteria:

* Informed consent
* Men and women, any race, aged 55 years or older at the baseline visit
* If both eyes meet the criteria to be study eye either eye will be included into the analysis.
* Patient is willing to undergo ocular examinations once every 6 for up to 24 months

Exclusion Criteria:

* The presence or history of CNV (choroidal neovascular membrane) in the study eye
* Ocular disease in the study eye that may confound assessment of the retina, other than non-exudative AMD (e.g., diabetic retinopathy, uveitis)
* Any systemic disease with a limited survival prognosis (e.g., cancer, severe/unstable cardiovascular disease).
* Any condition that would make adherence to the examination schedule of once every 6 months for up to 24 months difficult or unlikely, e.g., personality disorder, chronic alcoholism, Alzheimer's Disease or drug abuse
* Known medical history of allergy or sensitivity to tropicamide or fluorescein dye that is clinically relevant in the investigator's opinion

Answer: D