| Eligibility |
Inclusion Criteria
- Must sign an IRB approved informed consent form before any study-specific procedures
are initiated.
- Men or women =18 years old.
- Treatment-naïve or previously treated neovascular age-related macular degeneration,
diabetic macular edema, macular edema following retinal vein occlusion, or diabetic
retinopathy in the study eye.
Exclusion Criteria
- Active intraocular or periocular infection or active intraocular inflammation in
either eye.
- Uncontrolled intraocular pressure greater than (>) 25 mmHg in the study eye.
- Deemed legally blind in one or both eyes.
- History of or any current indication of excessive bleeding or recurrent hemorrhages,
including any prior excessive intraocular bleeding or hemorrhages after IVT injection
or intraocular procedures in either eye.
- Current systemic infectious disease or on a therapy for active infectious disease.
- History of any medical, ocular or non-ocular conditions that, in the opinion of the
investigator, may interfere with the injection procedure or pose a safety concern.
- History of stroke or transient ischemic attacks or myocardial infarction within the
last 6 months.
- Treatment with anti-VEGF IVT injection in the study eye within 28 days.
- Any use of intraocular corticosteroids in the study eye within 3 months.
- Receipt of any systemic anti-VEGF within the last 6 months.
- Any invasive intraocular surgery, prior long-acting therapeutic agent, or ocular drug
release device implantation in the study eye within the past 3 months.
- For women: pregnant or breast feeding, or planning to become pregnant while enrolled
in the study and for 3 months after IP administration.
- Sexually active participants and their partners who are of childbearing potential who
refuse to use adequate contraception while on-study and for 3 months after IP
administration. Male participants must agree not to donate sperm during study and for
3 months following dose of IP.
- Allergy or hypersensitivity to the IP, to any of the excipients of ABP 938 or
aflibercept, or to other study-related procedures/medications.
- Previously enrolled in this study.
- Participation in any interventional clinical study within 3 months prior to screening.
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