Please select the eligibility criteria that correspond to the clinical trial below.
Title: INTRAVITREAL RANIBIZUMAB FOR PERSISTENT NEW VESSELS IN DIABETIC RETINOPATHY (INIPE STUDY)
Brief Summary: To evaluate the fluorescein angiographic and visual acuity effects of a single intravitreal injection of ranibizumab for the management of persistent new vessels associated with diabetic retinopathy.


Options:
A: Inclusion Criteria:

* persistent new vessels,defined as fine retinal vessels with dilated buds or tips covered with hemorrhage or associated with recurrent vitreous hemorrhage or paucity of accompanying fibrous tissue and/or increased in extent compared to previous visit,unresponsive to complete panretinal laser photocoagulation performed at least 4 months prior;
* logarithm of minimum angle of resolution (logMAR) best-corrected visual acuity of 0.17 (Snellen equivalent, 20/30) or worse.

Exclusion Criteria:

* history of vitrectomy in the study eye;
* history of thromboembolic event (including myocardial infarction or cerebral vascular accident);
* major surgery within the prior 6 months or planned within the next 28 days;
* uncontrolled hypertension;
* known coagulation abnormalities or current use of anticoagulative medication other than aspirin.
B: Inclusion Criteria:

* Active fibrovascular proliferation due to PDR with TRD given pre-operative clearance for pars plana vitrectomy (PPV) and TRD repair.

Exclusion Criteria:

* Dense vitreous hemorrhage
* Inability to follow-up for surgery within 3-7 days after intravitreal injection
* History of stroke, thromboembolic event, or heart attack within the last 6 months
* Less than 18 years of age
* Pregnancy
C: Inclusion Criteria:

* High-risk proliferative diabetic retinopathy (HR-PDR) eyes.
* Best Corrected-Visual Acuity at baseline \> 20/320 in the study eye.
* Clear ocular media and adequate pupillary dilatation to permit good quality fundus photography.
* Intraocular pressure \< 21 mmHg.
* Type I, or Type II diabetic subjects as defined by the World Health Organization criteria of either gender, and aged ≥ 18 years.
* Women must be using effective contraception, be post-menopausal for at least 12 months prior to trial entry, or surgically sterile.
* Ability to provide written informed consent.
* Ability to return for all trial visits.

Exclusion Criteria:

* Eyes with prior scatter (panretinal) or focal/grid photocoagulation, within the previous 6 months.
* Fibrovascular proliferation with retinal traction.
* Other cause of retinal neovascularization (retinal vein occlusion, radiation retinopathy or others).
* Atrophy/scarring/fibrosis/ hard exudates involving the center of the macula.
* Subjects who have received yttrium-aluminum-garnet laser, or peripheral retinal cryoablation, or laser retinopexy (for retinal tears only), or focal/grid photocoagulation, within the previous 6 months.
* Significant media opacities, which might interfere with visual acuity, assessment of toxicity or fundus photography.
* Subjects should not be entered if there is likelihood that they will require cataract surgery within the following 1 year.
* Any intraocular surgery within 6 months before trial enrollment.
* Previous vitrectomy.
* HbA1C level \>11% or recent signs of uncontrolled diabetes.
* Any of the following underlying systemic diseases:

  * History or evidence of severe cardiac disease.
  * History or evidence of clinically significant peripheral vascular disease such as intermittent claudication or prior amputation.
  * Clinically significant impaired renal function (serum creatinine \>2.5 mg/dL or s/p renal transplant or receiving dialysis).
  * Clinically significant impaired hepatic function.
  * Stroke (within 12 months of trial entry).
  * Any major surgical procedure within one month before trial enrollment.
* Previous radiation to the head in the region of the study eye.
* Any prior treatment with an investigational agent for diabetic retinopathy or anti-VEGF therapy (including intravitreal, subconjunctival or subtenons corticosteroids) during the past 90 days for any other condition.
* Known serious allergies to fluorescein used in angiography, or to components of Lucentis® formulation.
* Systolic Blood Pressure \> 170 (2 different readings) or diastolic Blood Pressure \> 100 (2 different readings).
* Acute ocular or periocular infection.
* Previous filtering surgery (e.g., trabeculectomy) or placement of a glaucoma drainage device (e.g., tube-shunt surgery).
* Use of other investigational drugs at the time of enrollment.
* History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
* History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (\> 5 mIU/mL).
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant UNLESS they are: women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner; women whose partners have been sterilized by vasectomy or other means using a highly effective method of birth control. Periodic abstinence are not acceptable.
D: Inclusion Criteria:

* Willingness to provide written informed consent and, at U.S. sites, Health Insurance Portability and Accountability Act (HIPAA) authorization, and in other countries, as applicable according to national laws.
* Age ≥ 18 years.
* Diabetes mellitus (Type 1 or 2) .
* Retinal thickening secondary to diabetes mellitus (DME) involving the center of the fovea with central macular thickness ≥ 275 µm in the center subfield as assessed on optical coherence tomography (OCT).
* Best corrected visual acuity (BCVA) score in the study eye of 20/40 to 20/320 approximate Snellen equivalent using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at an initial testing distance of 4 meters.
* Decrease in vision determined to be primarily the result of DME and not to other causes.
* For sexually active women of childbearing potential, use of an appropriate form of contraception (or abstinence) for the duration of the study.
* Ability (in the opinion of the investigator) and willingness to return for all scheduled visits and assessments.

Exclusion Criteria:

* History of vitreoretinal surgery in the study eye.
* Panretinal photocoagulation (PRP) or macular laser photocoagulation in the study eye within 3 months of screening.
* Previous use of intraocular corticosteroids in the study eye (eg, triamcinolone acetonide \[TA\]) within 3 months of screening.
* Previous treatment with anti-angiogenic drugs in either eye (pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc) within 3 months of the Day 0 (first day of treatment) visit.
* Proliferative diabetic retinopathy (PDR) in the study eye, with the exception of inactive, regressed PDR.
* Iris neovascularization, vitreous hemorrhage, traction retinal detachment, or preretinal fibrosis involving the macula in the study eye.

Concurrent Ocular Conditions

* Vitreomacular traction or epiretinal membrane in the study eye.
* Ocular inflammation (including trace or above) in the study eye.
* History of idiopathic or autoimmune uveitis in either eye.
* Structural damage to the center of the macula in the study eye that is likely to preclude improvement in VA following the resolution of macular edema, including atrophy of the retinal pigment epithelium (RPE), subretinal fibrosis, or organized hard-exudate plaque.
* Ocular disorders in the study eye that may confound interpretation of study results, including retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization (CNV) of any cause (eg, age-related macular degeneration (AMD), ocular histoplasmosis, or pathologic myopia).
* Concurrent disease in the study eye that would compromise visual acuity or require medical or surgical intervention during the study period.
* Cataract surgery in the study eye within 3 months, yttrium-aluminum-garnet (YAG) laser capsulotomy within the past 2 months, or any other intraocular surgery within the 90 days preceding Day 0.
* Aphakia or absence of the posterior capsule in the study eye.
* Uncontrolled glaucoma or previous filtration surgery in the study eye.
* Spherical equivalent of the refractive error in the study eye of more than -8 diopters myopia.
* Evidence at examination of infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye or current treatment for serious systemic infection.
* Uncontrolled blood pressure.
* History of cerebral vascular accident or myocardial infarction within 3 months prior to Day 0.
* Uncontrolled diabetes mellitus.
* Renal failure requiring dialysis or renal transplant.
* Participation in an investigational trial within 30 days prior to screening that involved treatment with any drug (excluding vitamins and minerals) or device.
* 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 an investigational drug, might affect interpretation of the results of the study, or renders the subject at high risk from treatment complications.
* Pregnancy or lactation.
* History of allergy to fluorescein.
* History of allergy to ranibizumab injection or related molecule.

Answer: A