Subject Inclusion Criteria. Provide signed written informed consent on the IRB / EC approved Informed Consent Form (ICF) and provide authorization as appropriate for local privacy regulations.
1. Male or female 55 years of age or older on the date of signing the ICF and able and willing to comply with all treatment and follow-up study procedures.
2. Must have had prior treatment in the study eye with any intravitreal anti-VEGF medication (at least 3 anti-VEGF treatments within the prior 2-6 months), throughout which clinical examination and SD-OCT imaging has shown recurrent or persistent exudative activity, as shown by the presence of intraretinal or subretinal fluid, and/or subretinal exudation or hemorrhage. 3. BCVA of 65 to 10 ETDRS letters (20/50 to ≥20/640) in the study eye.
Subject Inclusion Criteria. The following inclusion criteria must be met for individuals to be eligible for the study.
1. Subject has signed an ICF prior to any study-specific procedures being performed.
2. Subject is an ambulatory female between 18 and 45 years of age, inclusive.
3. Subject is in good physical health and has no clinically significant findings, as determined by the Investigator, on physical examination, 12-lead ECG, or clinical laboratory tests.
4. Subject agrees to adhere to the study requirements.
5. Subject either must have ceased lactating at screening or, if still lactating or actively breastfeeding at screening, must agree to temporarily cease giving breast milk to her infant(s) from just prior to receiving study drug through Day 21, allowing for a 7-day washout after the last dose of study drug.
6. Subject must have a negative pregnancy test at screening and Day 1 prior to the start of study drug administration.
7. Subject has had a major depressive episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery, and meets criteria for major depressive episode per DSM-5, diagnosed by Structured Clinical Interview for (DSM-5) Axis I Disorders (SCID-I).
8. Subject has a HAM-D total score of ≥26 at screening and Day 1 (prior to randomization).
9. Subject is ≤6 months postpartum.
10. Subject is willing to delay start of other antidepressant or anxiety medications and any new pharmacotherapy regimens, including as-needed benzodiazepine anxiolytics, until after the Treatment Period ends and all Day 15 assessments have been completed.
11. Subject has no detectable hepatitis B surface antigen (HBsAg), no detectable anti- hepatitis C virus (HCV), detectable anti-HCV but negative viral load, and no detectable human immunodeficiency virus (HIV) antibody at screening.
12. Subject agrees to use 1 of the following methods of contraception during participation in the study and for 30 days following the last dose of study drug, unless they are surgically sterile: • Combined (estrogen and progestogen containing) oral, intravaginal, or transdermal hormonal contraception associated with inhibition of ovulation. • Oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation. • Intrauterine device. • Intrauterine hormone-releasing system. • Bilateral tubal occlusion. • Vasectomized partner.
Subject Inclusion Criteria. A1. Patients must be resistant to the most recent platinum-based therapy, defined for the purpose of this protocol as progression within 6 months from completion of a minimum of 4 cycles of platinum-containing therapy. This should be calculated from the date of the last administered dose of platinum therapy to the date of the radiographic imaging showing disease progression. Patients with primary platinum-refractory disease as defined by those who progressed during or within 4 weeks of completion of first platinum-based chemotherapy are not eligible.
