Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Study Comparing the Safty Anf Efficacy of Ranibizumab (Lucentis®) to Sham in Patients With Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO
Brief Summary: A prospective multicenter study comparing patients with CRVO amd secondary macular edema treated with ranibizumab versus sham. Safety and efficacy will be evaluated. Patients will be randomized in a 1:1 ratio to one of the two arms. 32 patients, 6 months follow up. There will be monthly visits with injection the first three months and subsequently new injection if present edema.


Options:
A: DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed adenocarcinoma of the breast
* Locally recurrent disease that is not amenable to surgical resection with curative intent OR
* Metastatic disease
* No HER-2-overexpressing (3+) breast cancer unless previously treated with trastuzumab (Herceptin)

  * Unknown HER-2 status allowed provided herceptin-based therapy inappropriate or not indicated
* No prior or radiologic evidence of CNS metastases, including previously treated, resected, or asymptomatic brain lesions or leptomeningeal involvement by head CT scan or MRI
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Sex:

* Male or female

Menopausal status:

* Not specified

Performance status:

* ECOG 0-1

Life expectancy:

* Not specified

Hematopoietic:

* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* No prior bleeding diathesis

Hepatic:

* Bilirubin no greater than 1.5 mg/dL
* SGOT no greater than 2 times upper limit of normal (ULN) (5 times ULN for known liver involvement)
* PT/PTT no greater than 1.5 times normal
* INR no greater than 1.5 times normal

Renal:

* Creatinine no greater than 2.0 mg/dL
* No proteinuria by dipstick urinalysis
* Trace proteinuria allowed
* Proteinuria less than 500 mg by 24-hour urine collection if proteinuria at least 1+ by urinalysis

Cardiovascular:

* No clinically significant cardiovascular disease
* No myocardial infarction within the past 12 months
* No unstable angina
* No prior deep vein thrombosis
* No grade 2 or greater peripheral vascular disease
* No uncontrolled congestive heart failure
* No uncontrolled hypertension (systolic blood pressure greater than 170 mmHg and diastolic blood pressure greater than 95 mm Hg)
* No prior cerebrovascular accident

Pulmonary:

* No prior pulmonary embolism

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective non-hormonal contraception
* No history of seizures
* No non-healing wound or fracture
* No hypersensitivity to paclitaxel, Cremophor EL, Chinese hamster ovary cell products, or other recombinant human antibodies
* No active infection requiring parenteral antibiotics

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* See Disease Characteristics

Chemotherapy:

* No prior chemotherapy for locally recurrent or metastatic breast cancer
* At least 12 months since prior adjuvant or neoadjuvant taxane therapy
* At least 3 weeks since prior adjuvant chemotherapy

Endocrine therapy:

* At least 3 weeks since prior hormonal therapy for locally recurrent or metastatic breast cancer

Radiotherapy:

* At least 3 weeks since prior radiotherapy
* No prior radiotherapy to only site of disease
* No concurrent local radiotherapy for pain control or life-threatening situations (e.g, superior vena cava syndrome, spinal cord compression, or CNS metastases)

Surgery:

* At least 4 weeks since prior major surgical procedure except placement of vascular access device or breast biopsy
* At least 7 days since prior minor surgical procedure, including placement of an access device or fine needle aspiration

Other:

* At least 10 days since prior anticoagulant therapy (low-dose anticoagulant therapy to maintain patency of a vascular access device allowed)
* At least 10 days since prior and no concurrent daily aspirin (more than 325 mg/day) or other non-steroidal anti-inflammatory medication known to inhibit platelet function
* No concurrent dipyridamole, ticlopidine, clopidogrel, or cilostazol
B: Inclusion Criteria:

* CRVO must have occurred within the past 6 months and be associated with macular edema determined by OCT.
* Vision in the study eye corresponding to between approximately 20/50 to 20/400 and better than or equal to approximately 20/200 in the fellow eye.

Exclusion Criteria:

* Presence of signs of old branch retinal vein occlusion (BRVO) or CRVO in the study eye or any other retinal vascular disease including diabetic retinopathy.
* Vitreous hemorrhage except breakthrough hemorrhage from intraretinal hemorrhage.
* Prior pan retinal photocoagulation (PRP) or sector scatter photocoagulation.
C: Inclusion Criteria:

1. Male and female ≥ 50 years
2. Patients who have findings consistent with CRVO
3. Patients who have a history of decreased visual acuity ≤ 6 months
4. Patients who have a best corrected visual acuity (BCVA) letter score in the study eye of ≤ 73 (4 m distance) or ≥ 6 (1 m distance) using an ETDRS chart
5. Patients who have a macular edema verified by OCT
6. Patients who have macular edema in the study eye with the following characteristics as determined by fluorescein angiography:

   * secondary to non-iscemic CRVO defined as non-perfusion \< 10 DA OR
   * secondary to ischemic CRVO defined as non-perfusion \> 10 DA
7. Willing and able to give written informed consent and who are willing and able to comply with study procedures
8. Ability to cooperate with photo and OCT examinations

Exclusion Criteria:

1. Neovascularisations in the study eye at baseline
2. Previous treatment with or participation in a clinical trial (for either eye) involving anti-angiogenics drugs
3. Use of other investigational drugs
4. Prior treatment in the study eye with verteporfin, external-beam radiation therapy, subfoveal laser photocoagulation, vitrectomy, or transpupillary thermotherapy.
5. History of submacular surgery in the study eye, glaucoma filtration, corneal transplantation surgery
6. Previous or current intravitreal or sub-Tenon drug delivery in the study eye
7. Laserphotocoagulation (juxtafoveal or extrafoveal) in the study eye within one month preceding Baseline
8. Extracapsular extraction of cataract with phacoemulcification within three months preceding Baseline, or a history of post-complications within the last 12 months preceding Baseline in the study eye (uveitis, cyclitis etc)
9. History of uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma medication)
10. Previous violation of the posterior capsule in the study eye unless it occurred as a result of YAG laser posterior capsulotomy in assosiation with prior, posterior chamber lens implantation
11. Afakia with absence of the posterior capsule in the study eye
12. Active intraocular inflammation in the study eye
13. Any active infection involving the ocular adnexa including infectious conjunctivitis, keratitis, scleritis, endophthalmitis, as well as ideopathic or autoimmune-associated uveitis in either eye
14. Vitreous hemorrhage or history og rhegmatogenous retinal detachment or macular hole in the study eye
15. Any current intraocular condition in the study eye (cataract or diabetic retinopathia) that in the opinion of the investigator, could either require medical or surgical intervention during the study period for the next 6 months
16. Ocular condition that requires chronic concomitant therapy with systemic or topical ocular corticosteroids.
17. Current treatment for active systemic infection.
18. Current use or likely need for systemic medications known to be toxic to the lens, retina or optic nerve.
19. History of other diseases, 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 might affect interpretation of the results of the study or render the subject at high risk for treatment complications
20. History of hypersensitivity or allergy to fluorescein
21. Inability to obtain fundus photographs or fluorescein angiograms of sufficient quality to be analyzed
22. Pregnant or nursing (lactating) women
23. Pre-menopausal women of child-bearing potential not using adequate contraception.
24. History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrance or metastases.
D: 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

Answer: C