CLN-0046: Treatment of AMD Subjects With OTX-TKI

A multi-center, dose escalation, Phase 1, safety, tolerability and efficacy study to evaluate three dose groups of the OTX-TKI implant to treat subjects with a diagnosis of primary subfoveal neovascularization secondary to AMD.

Inclusion criteria

• Are at least 50 years of age
• Are eligible for standard therapy
• Have active primary CNVM secondary to AMD, either newly diagnosed or previously treated with documented response to anti-VEGF therapy in the study eye [primary subfoveal CNV secondary to AMD including juxtafoveal lesions that affect the fovea] documented by FA and SD-OCT
• Are female who is postmenopausal for at least 12 months prior to screening or surgically sterile; or male or female of childbearing potential willing to use two forms of adequate contraception
• Are able and willing to comply with all study requirements and visits

Exclusion criteria

• Have previous laser photocoagulation to the center of the fovea in the study eye
• Have participated in any study involving an investigational drug either in the U.S. or outside the U.S. within the past 30 days
• Are an employee of the site that is directly involved in the management, administration, or support of the study, or be an immediate family member of the same
• Have a presence of a disease other than CNVM due to AMD in the study eye that could affect vision or safety assessments