A Study of the Safety and Tolerability of ASP7317 in Senior Adults Who Are Losing Their Clear, Sharp Central Vision Due to Geographic Atrophy Secondary to Dry Age-related Macular Degeneration

Participant has a history of recurrent varicella zoster virus (VZV) infection or a clinical diagnosis of VZV infection within 4 weeks of the baseline visit or positive anti-VZV immunoglobulin M (IgM). Being positive for immunoglobulin G (IgG), indicative of a past infection (or vaccination), is not an exclusionary criterion.

Participant has a history of recurrent cytomegalovirus (CMV) infection or a clinical diagnosis of CMV infection within 4 weeks of the baseline visit or positive anti-CMV IgM. Being positive for IgG, indicative of a past infection, is not an exclusionary criterion.

Participant has a positive tuberculosis (TB) test during the screening period by an interferon gamma release assay (e.g., QuantiFERON) within the 6 months prior to the screening. If a participant has tested negative for TB within the 6 months prior to the screening visit, retesting is not required unless clinically indicated.

Participant has a history or suspected active infection of toxoplasmosis or presence of elevated immunoglobulin M (IgM) toxoplasmosis titer within 4 weeks of the baseline visit.

Participant has an active infection (ocular or non-ocular) requiring the prolonged or chronic use of antimicrobial or anti-infective agents.

Participant has a current malignancy or history of malignancy within the past 5 years, except non-metastatic basal or squamous cell carcinoma or keratoacanthoma or Bowen's disease or carcinoma-in-situ of the cervix that has been successfully treated.

Participant has a history of a solid organ or bone marrow transplant.

Participant has any condition that would prohibit the use of systemic immunosuppression with tacrolimus.

Participant is receiving or has received any immunosuppressive therapy (IMT) (other than topical, inhaled or low dose systemic corticosteroid use not exceeding 7.5 mg of prednisone daily \[or equivalent\]) within 6 weeks or 5 plasma half-lives, whichever is longer, prior to the administration of adjunct study medications.

Participant has a history of myocardial infarction in previous 12 months and whose disease is either unstable and/or symptomatic (e.g., angina, dyspnea, etc.).

Participant has electrocardiogram (ECG) results that are clinically significant and could either jeopardize the safety of the participant, impact the participant's ability to comply with study visit schedule or impact the validity of the study results. Participants with a mean Fridericia-corrected QT interval of \> 430 ms (for males) and \> 450 ms (for females) at screening must be cleared by a cardiologist prior to the baseline visit.

Participant has a study day diastolic blood pressure \> 95 mmHg, at either the screening or baseline visit. Study day blood pressure is defined as the average of the second and third readings at a study visit. If the study day blood pressure exceeds the limits, 1 additional triplicate can be taken.

Participant has an estimated glomerular filtration rate (eGFR) of \</= 30 mL/min, calculated by the chronic kidney disease epidemiology collaboration (CKD-EPI) equation.

Participant has an alanine aminotransferase (ALT), aspartate aminotransferase (AST) or gamma- glutamyltransferase (GGT) and total bilirubin (TBL) \>/= 2 times the upper limit of normal (ULN).

Participant has severe anemia (hemoglobin \< 9 g/dL \[male\] or hemoglobin \< 8 g/dL \[female\]), leucopenia (white blood cell count \< 2500/mm\^3), thrombocytopenia (platelet count \< 80000/mm\^3) or polycythemia (hematocrit \> 54% \[male\] or hematocrit \> 49% \[female\]).

Participant has a hemoglobin A1c \> 8.5%.

Participant has a clinically significant coagulopathy (i.e., activated partial thromboplastin time \[aPTT\] \>/= 1.5 times the ULN and/or prothrombin time adjusted for the international normalized ratio \[PT-INR\] \>/=2.0).

Participant has serology results indicative of having syphilis, Lyme disease, human immunodeficiency virus infection or active infection with hepatitis A virus (HAV), hepatitis B virus (HBV), hepatitis C virus (HCV), or varicella-zoster virus (VZV).

Participant has a history of familial adenomatous polyposis or inflammatory bowel disease (i.e., Crohn's disease, ulcerative colitis).

Participant has a history of allergic reaction to mydriatics or fluorescein.

Participant has a history of gene therapy or cell transplant therapy, including ASP7316, in a prior clinical study.

Participant has participated in any studies of an investigational drug or procedure (excluding vitamins and minerals for AMD studies) within 12 weeks prior to the screening visit, except as noted in below criterion.

Participant has participated with the study eye in any trial of a now FDA-approved complement inhibitor and/or has received an FDA approved complement inhibitor injection in the study eye within 24 weeks of the screening visit. After a washout period of 24 or more weeks, participants previously treated with a complement inhibitor will be eligible for participation, but participants will not be allowed to resume receiving any approved or investigational complement inhibitor in the study eye until the completion of the 52-week follow up period of the A7317-CL-0003 trial. Use of an FDA-approved complement inhibitor in the fellow, non-study eye is allowable.

Participant is unwilling to discontinue or avoid any CYP3A4 inducers (e.g., rifampin, rifabutin, phenytoin, carbamazepine, phenobarbital, St John's Wort) or participant is unwilling to discontinue or avoid protease inhibitors (e.g., nelfinavir, telaprevir, boceprevir), direct Factor Xa inhibitors, direct thrombin inhibitors, verapamil, diltiazem or erythromycin while taking tacrolimus.

Participant has a positive urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, opiates, cocaine, phencyclidine and methadone), unless the drug is taken for a documented medical condition and under the supervision of a physician.

Participant has macular degeneration due to causes other than AMD (e.g., Stargardt disease, cone rod dystrophy, toxic maculopathies, etc.)

Participant has developed CNV (wet AMD), also known as exudative AMD in either eye.

Participant has foveal sparing as determined by the presence of potentially viable photoreceptors, as evidenced by presence of an intact ellipsoid zone (EZ) \</= 250 microns from the foveal center, based on reading center assessments at the screening visit.

What this study is about