Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Patients With Diabetic Macular Edema (YOSEMITE)
Brief Summary: This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab administered at 8-week intervals or as specified in the protocol following treatment initiation, compared with aflibercept once every 8 weeks (Q8W), in participants with diabetic macular edema (DME).


Options:
A: 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.
B: Inclusion Criteria:

* Documented diagnosis of diabetes mellitus (Type 1 or Type 2)
* Hemoglobin A1c (HbA1c) of less than or equal to (≤) 10% within 2 months prior to Day 1
* Macular thickening secondary to diabetic macular edema (DME) involving the center of the fovea
* Decreased visual acuity attributable primarily to DME
* Ability and willingness to undertake all scheduled visits and assessments
* For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods that result in a failure rate of \<1% per year during the treatment period and for at least 3 months after the final dose of study treatment

Exclusion Criteria:

* Currently untreated diabetes mellitus or previously untreated patients who initiated oral or injectable anti-diabetic medication within 3 months prior to Day 1
* Uncontrolled blood pressure, defined as a systolic value greater than (\>)180 millimeters of mercury (mmHg) and/or a diastolic value \>100 mmHg while a patient is at rest
* Currently pregnant or breastfeeding, or intend to become pregnant during the study
* Treatment with panretinal photocoagulation or macular laser within 3 months prior to Day 1 to the study eye
* Any intraocular or periocular corticosteroid treatment within the past 6 months prior to Day 1 to the study eye
* Prior administration of IVT faricimab in either eye
* Active intraocular or periocular infection or active intraocular inflammation in the study eye
* Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision in the study eye
* Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than DME in the study eye
* Other protocol-specified inclusion/exclusion criteria may apply
C: Inclusion Criteria:

1. Diabetic patients older than 18 years
2. Presence of PDR (presence of retinal neovascularization, defined as active neovessels (fine retinal vessels with saccular dilatations or extremities covered with blood or associated with recurrent vitreous hemorrhage) with visual acuity better than 20/800 and with no previous laser treatment
3. Giving written informed consent.

Exclusion Criteria:

1. Presence of advanced PDR, i.e.: vitreous hemorrhage that would prevent documentation of the eye fundus or adequate retinal photocoagulation, or presence of traction retinal detachment
2. Presence of ring-shaped retinal neovascularization extending along both temporal arcades and the optic disc
3. Any abnormality of the vitreoretinal interface in the macular region for which the investigator would consider vitrectomy via pars plana to be necessary
4. Intravitreous injection of corticosteroids or of other antiangiogenic drugs 6 months before the evaluation for entry into the study
5. Inability to fixate and to conclude the automated static perimetry exam
6. Cataract surgery within the last three months
7. Posterior vitrectomy with scleral introflexion at any time
8. Acute ocular infection
9. Allerghy to fluorescein
10. Medical or psychological conditions that would prevent the patient from giving informed consent and concluding the study
11. Significant uncontrolled diseases which, in the opinion of the investigator, would exclude the patient from the study
12. Renal failure requiring dialysis or renal transplant or renal insufficiency with creatinine levels \>2.0 mg/dl
13. Untreated diabetes mellitus
14. Severe (blood pressure systolic \> 160 mmHg or diastolic \> 100 mmHg) AND untreated hypertension
15. Inability to comply with study or follow-up procedures.
16. Impaired or limited legal capacity
17. Participation in another clinical study in the last 30 days.
D: Inclusion Criteria:

* vitreous haemorrhage
* tractional retinal detachment
* active proliferative diabetic retinopathy.

Exclusion Criteria:

* neovascular glaucoma
* cataract
* combined traction and rhegmatogenous RD

Answer: B