Clinical Trials

Inclusion Criteria:

• Patients aged ≥ 50 years.
• Active CNV associated with age-related macular degeneration as evidenced on FA and SD-OCT with presence of intraretinal or subretinal fluid at Screening with either the CNV or fluid involving the center of the fovea.
• Neovascular AMD patients who have had at least 3 anti-VEGF treatments in the study eye in the preceding 6 months prior to Screening, no less often, than approximately every 2 months
• BCVA in the study eye (most affected) of 70 to 20 ETDRS letters (equivalent to 20/40 to 20/400 on the Snellen chart) at Screening and at Day 1. On Day 1, BCVA cannot be 10 or more letters from Screening:
  • Note: if both eyes are eligible, the one with the poorer BCVA should be chosen. If BCVA is equal, the eye with the greatest potential for vision gains, in the opinion of the Investigator, should be selected.
• BCVA in the non-study eye of 35 ETDRS letters (equivalent to 20/200 on the Snellen chart) or better.
• IOP ≤ 23 mmHg in the study eye.
• Clear ocular media and adequate pupillary dilation to permit CFP, SD-OCT, and adequate BCVA evaluation.
• Patients who have the capacity to give informed consent and who are willing and able to comply with all study-related procedures and assessments.

Exclusion Criteria:

• Concurrent disease in the study eye or structural damage, other than nAMD, that could compromise BCVA, prevent BCVA improvement, require medical or surgical intervention during the study period, confound interpretation of the results, or interfere with assessment of toxicity or CFP in the study eye. This includes, but is not limited to, the following:
  • Macular edema of etiologies other than nAMD;
  • Clinically significant subretinal fibrosis;
  • Subfoveal lipid with atrophy involving center of fovea;
  • Cataract requiring surgery during the study period;
  • RPE atrophy or tear or rips involving the macula;
  • Presence of macular hole;
  • History of uveitis;
  • Vitreomacular traction;
  • Clinically significant epiretinal membrane (ERM);
  • Aphakia or Anterior Chamber Intraocular Lens (A/C IOL);
  • Other retinovascular disease.
• Any ocular/intraocular/periocular infection or inflammation in either eye in the past 4 weeks prior to Screening (mild blepharitis is acceptable)
• Subretinal hemorrhage with bleeding area ≥ 4 disc area in the study eye
• History of vitrectomy in the study eye
• History of intraocular, periocular, or corneal surgery in the study eye within 3 months prior to screening, or anticipated need for such surgery during the study
• History of panretinal photocoagulation (within 6 months) or macular laser photocoagulation (within 3 months) in the study eye prior to Day 1
• History of corneal transplant in the study eye
• Concomitant use of > 2 medications for the treatment of glaucoma and unstable glaucoma in the study eye (i.e., inadequate IOP control). Combination drugs, if given in a single drop, are considered 2 medications
• Any condition, including laboratory findings and findings in the medical history or in the pre-study assessments, that, in the opinion of the Investigator, constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation or prevent the patient from fully participating in all aspects of the study
• Presence of severe myopia (-8 diopters or greater) in the study eye
• The use of intraocular steroids in the study eye within the last 2 years prior to screening
• History of Visudyne® photodynamic therapy in the study eye
• Significant media opacities, including cataract, which might interfere with visual acuity, assessment of toxicity, or fundus imaging 
• Intraocular surgery, including cataract surgery, in the study eye ≤ 3 months of screening
• Known allergy to any component (phosphate buffered saline and polysorbate 80) of the Study Drug or to any component of Aflibercept, or a clinically relevant sensitivity to fluorescein dye
• Female patients who are pregnant, lactating, or of childbearing potential who do not agree to use highly effective methods of birth control (e.g., progesterone-only hormonal contraception, double barrier, or intrauterine device) during the study and for 3 months following the last dose of Study Drug. Postmenopausal females (> 45 years old and without menses for more than 1 year) and surgically sterilized females are exempt from these requirements.
• Male patients who do not agree to use a highly effective method of contraception during the study and for 3 months following the last dose of Study Drug, if sexually active with a female partner of childbearing potential.
• Patients who within 3 months of screening received or are concurrently on another investigational drug or vaccine study, including patients who previously received treatment in a UBX1325 study. Coronavirus Disease 2019 (COVID-19) vaccinations are permitted prior to or during the course of the study.
• Any uncontrolled medical condition, in the opinion of the Investigator, would preclude participation in this study, including, but not limited to, history of malignancy within the last 3 years (however, non-facial, basal cell carcinoma is allowed), history of myocardial infarction within the last 6 months, or concomitant therapy.

Eligibility last updated 9/3/21. Questions regarding updates should be directed to the study team contact.