Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase II Randomized, Dose-Ranging, Double-Masked, Multi-Center Trial, in Parallel Groups, Determining Safety, Efficacy and PK of Intravitreous Injections of Pegaptanib Sodium Compared to Sham Injection for 30 Weeks in Patients With Recent Vision Loss Due to Macular Edema Secondary to CRVO
Brief Summary: Eyetech Pharmaceuticals Inc. and Pfizer, Inc. are studying an investigational drug, MacugenTM, for the possible treatment of CRVO. An investigational drug is one that has not been approved by the U.S. Food and Drug Administration (FDA). This investigational drug may slow the growth of abnormal blood vessels in the eye and may reduce tissue swelling in the eye.

The purpose of this study is to compare the safety and efficacy of a Macugen™ injection to a "pretend" injection. In addition, the purpose of this study is to measure the action of the study drug in the body over a period of time and to check for the presence of the study drug in your blood (called pharmacokinetics or PK).

This study will involve approximately 90 people. People who decide to participate will have an equal chance (1 in 3) to receive one of three study injections, two of which are Macugen™ and one of which is a "pretend" injection.


Options:
A: 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.
B: 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.
C: Inclusion Criteria:

* Willingness to provide signed Informed Consent Form
* Age ≥ 18 years
* For sexually active women of childbearing potential, use of an appropriate form of contraception (or abstinence) for the duration of the study
* Ability and willingness to return for all scheduled visits and assessments

Ocular Inclusion Criterion (Study Eye):

* Foveal center-involved macular edema secondary to BRVO
* BCVA using ETDRS charts of 20/40 to 20/400 (Snellen equivalent)
* Mean central subfield thickness ≥ 250 μm on two optical coherence tomography (OCT) measurements (at screening \[confirmed by the central reading center\] and Day 0 \[confirmed by the evaluating physician\])
* Media clarity, pupillary dilation, and participant cooperation sufficient to obtain adequate fundus photographs

Exclusion Criteria:

* History of cerebral vascular accident or myocardial infarction within 3 months prior to Day 0
* History of any anti-vascular endothelial growth factor (VEGF) treatment in fellow eye within 3 months prior to Day 0
* History of any systemic anti-VEGF or pro-VEGF treatment within 6 months prior to Day 0
* History of allergy to fluorescein
* History of allergy to ranibizumab injection or related molecule
* Relevant systemic disease that may be associated with increased systemic VEGF levels (namely, all active malignancies); history of successfully treated malignancies is not an exclusion criterion
* Uncontrolled blood pressure
* Pregnancy or lactation
* Any condition that, in the opinion of the investigator, would preclude participation in the study (e.g., chronic alcoholism or drug abuse, personality disorder or use of major tranquilizers, indicated difficulty in long-term follow-up, and likelihood of survival of less than 1 year)
* Participation in an investigational trial within 30 days prior to Day 0 that involved treatment with any drug (excluding vitamins and minerals) or device that has not received regulatory approval at time of study entry

Ocular Exclusion Criteria (Study Eye):

* Prior episode of retinal vein occlusion (RVO)
* Brisk afferent pupillary defect
* History of radial optic neurotomy or sheathotomy
* History or presence of age-related macular degeneration (AMD; dry or wet form)
* History of any anti-VEGF treatment in the study eye within 3 months prior to Day 0
* History of laser photocoagulation for macular edema within 4 months prior to Day 0
* History of panretinal scatter photocoagulation or sector laser photocoagulation within 3 months prior to randomization or anticipated within the next 4 months following randomization
* History of intraocular corticosteroid use within 3 months prior to Day 0
* History of pars plana vitrectomy
* History of intraocular surgery (including cataract extraction, scleral buckle, etc.) within 2 months prior to Day 0 or anticipated within the next 7 months following Day 0
* History of yttrium-aluminum-garnet capsulotomy performed within 2 months prior to Day 0
* Previous filtration surgery in the study eye
* History of herpetic ocular infection
* History of ocular toxoplasmosis
* History of rhegmatogenous retinal detachment
* History of idiopathic central serous chorioretinopathy
* Evidence upon examination of vitreoretinal interface disease (e.g., vitreomacular traction, epiretinal membrane), either on clinical examination or OCT, thought to be contributing to macular edema
* An eye that, in the investigator's opinion, would not benefit from resolution of macular edema, such as eyes with foveal atrophy, dense pigmentary changes, or dense subfoveal hard exudates
* Presence of an ocular condition that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the study (e.g., uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass syndrome, or prior macula-off rhegmatogenous retinal detachment)
* Visually significant hemorrhage obscuring the fovea and felt to be a major contributor to reduced visual acuity
* Presence of a substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (i.e., a 20/40 cataract)
* Aphakia
* Relevant ocular disease that may be associated with increased intraocular VEGF levels (namely, uveitis, neovascular glaucoma, neovascular AMD, diabetic retinopathy, diabetic maculopathy, or ocular ischemic syndrome)
* Improvement of \> 10 letters on best corrected visual acuity (BCVA) between screening and Day 0
D: Inclusion Criteria:

* Participants with macular edema (swelling of the central part of the retina) associated with central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO).
* Individuals, 18 years of age or older, willing to provide consent may be eligible for the SCORE Study.

Exclusion Criteria: refer to SCORE Study website at https://web.emmes.com/study/score/ for listing.

Answer: A