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

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the safety, tolerability and efficacy of OTX-TKI for intravitreal use, in subjects who have neovascular age-related macular degeneration (AMD).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ocular Therapeutix, Inc.
• Treatments: Aflibercept; Bevacizumab; Ranibizumab

Criteria

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