Neovascular Age-related Macular Degeneration
Conditions
Brief summary
To evaluate the safety, tolerability and efficacy of OTX-TKI for intravitreal use, in subjects who have neovascular age-related macular degeneration (AMD).
Detailed description
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.
Interventions
Sponsors
Ocular Therapeutix, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment emergent adverse events for each subject | 9 months | All adverse events from screening through end of study will be captured |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determine the Maximum Tolerated Dose of the OTX-TKI injection | 9 months | A Central Reading Center will evaluate multiple imaging modalities to confirm evidence of biological activity for subjects that have been treated with the OTX-TKI injection. If all subjects tolerate lower dosages, additional subjects will be treated at higher dosages. All data will be evaluated by the DSMC who, in concert with the Medical Monitor, will determine the Maximally Tolerated Dose. |
Countries
Australia
Outcome results
None listed