NCT03630315CompletedPhase 1
CLN-0046: Treatment of AMD Subjects With OTX-TKI
A Phase 1 Open-Label, Dose Escalation Study of OTX-TKI for Intravitreal Use in Subjects With Neovascular Age-Related Macular Degeneration (AMD)
Source: ClinicalTrials.gov · Last updated 10 Jul 2024
Brief summary (registry, in English)
To evaluate the safety, tolerability and efficacy of OTX-TKI for intravitreal use, in subjects who have neovascular age-related macular degeneration (AMD).
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 29 (actual)
- First submitted
- 1 Jun 2018
- Start date
- 18 Feb 2019
- Primary completion date
- 10 Jan 2024
- Lead sponsor
- Ocular Therapeutix, Inc.
- Diseases
- Macular degeneration
- NCT number
- NCT03630315
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 29
- From 18 Feb 2019 to the primary completion date, 10 Jan 2024
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Have a presence of a disease other than CNVM due to AMD in the study eye that could affect vision or safety assessments
Other
- 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
Who the study is looking for
- 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
Age in the registry: 50 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ocular Therapeutix, Inc. Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
| Ocular Therapeutix, Inc. Coordinator of this site? Confirm its status | Albury | Australia | Unknown status |
| Ocular Therapeutix, Inc. Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Ocular Therapeutix, Inc. Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
| Ocular Therapeutiux, Inc. Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.