Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase Ib/II, Multicenter, Randomized, Single-Masked, Sham Injection-Controlled Study of Safety, Tolerability, and Evidence of Activity of FCFD4514S Intravitreal Injections Administered Monthly or Every Other Month to Patients With Geographic Atrophy
Brief Summary: This is a Phase Ib/II, multicenter, randomized, single-masked, sham-injection-controlled study of safety, tolerability, and evidence of activity of FCFD4514S intravitreal injections administered monthly or every other month in patients with geographic atrophy.


Options:
A: Inclusion Criteria:

* Willingness and ability to provide signed Informed Consent; in addition, at U.S. sites, Health Insurance Portability and Accountability Act (HIPAA) authorization, in other countries, as applicable according to national laws
* Well-demarcated area of GA secondary to age-related macular degeneration (AMD) in the absence of choroidal neovascularization (CNV)

Exclusion Criteria:

* History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye
* Previous subfoveal focal laser photocoagulation in the study eye
* Laser photocoagulation in the study eye
* Prior treatment with Visudyne, external-beam radiation therapy, or transpupillary thermotherapy in the study eye
* GA in either eye due to causes other than AMD
* Diabetic retinopathy in either eye
* Active or history of wet AMD in either eye
* 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 or that might affect interpretation of the results of the study or that renders the patient at high risk for treatment complications
* Active malignancy or history of malignancy within the past 5 years
* Previous participation in any studies of investigational drugs within 3 months preceding Day 0
B: Group B: Patients with evidence of large hemorrhages from subfoveal neovascular AMD lesions, visual acuity (SST protocol) of 20/100 to light perception, with the area of hemorrhage larger than the area of fluorescein angiographically visible CNV, with any visible CNV less than or equal to 9 MPS disc areas, and ability to return for 4 years of follow-up may be eligible for the Group B (Blood) protocol.

Group N: Patients with new CNV (no prior laser) due to AMD, visual acuity (SST protocol) of 20/100 to 20/800, fluorescein angiographic evidence of subfoveal CNV lesion which is less than or equal to 9 MPS disc areas, and ability to return for 4 years of follow-up may be eligible for the Group N (New CNV) protocol.

Group H: Patients with evidence of CNV due to OHS or idiopathic cause, visual acuity (SST protocol) 20/50 to 20/800, fluorescein angiographic evidence of subfoveal CNV lesion (new or recurrent) which is \< 9 MPS disc areas, and ability to return for 4 years of follow-up may be eligible for inclusion in the Group H (Histoplasmosis/Idiopathic CNV) protocol. Exclusion criteria include other ocular diseases compromising vision, history of submacular surgery in the study eye, history of subfoveal laser photocoagulation that extends under the foveal avascular zone, recent intraocular surgery, or previous investigational therapy for CNV.
C: Inclusion Criteria:

* Well demarcated area(s) of Geographic Atrophy (GA) secondary to Age-Related Macular Degeneration (AMD) with no evidence of prior or active choroidal neovascularization (CNV) in both eyes

Exclusion Criteria:

Ocular Exclusion Criteria: Study Eye

* History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
* Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, and proliferative diabetic retinopathy
* Previous intravitreal drug delivery (intravitreal corticosteroid injection, anti-angiogenic drugs, anti-complement agents, or device implantation) Ocular Exclusion Criteria: Both Eyes
* GA in either eye due to causes other than AMD
* Previous treatment with eculizumab, lampalizumab and/or fenretinide
D: Inclusion Criteria

1. Participant must understand and sign the protocol's informed consent document (if the participant's vision is impaired to the point where it is not possible to read the informed consent document, the informed consent document will be read in its entirety to the participant).
2. Participant must be able to administer the eye drops or have a caretaker administer the eye drops.
3. Participant must have geographic atrophy (GA) present in both eyes compatible with age-related macular degeneration (AMD). GA is defined as one or more well-defined, usually more or less circular patches of partial or complete depigmentation of the RPE, typically with exposure of underlying choroidal blood vessels. Even if much of the RPE appears to be preserved and large choroidal vessels are not visible, a round-ish patch of RPE partial depigmentation may still be classified as early GA. The GA in each eye must be able to be photographed in their entirety and not contiguous with any areas of peripapillary atrophy, which can complicate area measurements.
4. Participant must have a steady fixation in the study eye in the foveal or parafoveal area and media clear enough for good quality photographs.
5. Female participants of child bearing potential (those who are not post-menopausal or surgically sterile) may participate if they are not lactating and if they agree to adequate birth control methods.

4.5 Exclusion Criteria

1. Participant is \> 60 years of age (to minimize fundus changes from causes other than AMD).
2. Participant is in another investigational study and actively receiving study therapy.
3. Participant is unable to comply with study procedures or follow-up visits.
4. Participant has evidence of ocular disease other than AMD in either eye that may confound the outcome of the study (e.g., diabetic retinopathy, uveitis, etc.).
5. Participant has a chronic requirement (e.g., ≥ four weeks at a time) for ocular medications for diseases, that in the judgment of the examining physician, are vision threatening or may affect the primary outcome (artificial tears are permitted).
6. Participant has evidence of pseudovitelliform macular degeneration that may confound the outcome of the study in either eye.
7. Participant with evidence of vitreo-retinal traction maculopathy that may confound the outcome of the study in either eye.
8. Participant has a history of laser, photodynamic therapy (PDT), intravitreal injection of any agent (e.g., anti-VEGF, triamcinolone, etc.), or any previous treatment for AMD other than AREDS or equivalent supplement formulation in the study eye.
9. Participant has had a vitrectomy, penetrating keratoplasty, trabeculectomy or trabeculoplasty.
10. Participant has undergone lens removal in the last three months.
11. Participant is on chemotherapy.
12. Participant is on ocular or systemic medications known to be toxic to the lens, retina, or optic nerve.
13. Participant with a history of malignancy that would compromise the 2-year study survival.
14. Participant with a history of ocular Herpes simplex virus.
15. Participant with a history of or demonstration of allergy to benzakonium chloride, a preservative agent used in the eye drop.

Answer: A