NCT06015633Active, not recruiting
Ocular, Vascular, and Genetic Findings in AMD Patients
Exploration of Ocular, Vascular, and Genetic Findings Associated and Correlated with the Presence of Late-stage AMD
Source: ClinicalTrials.gov · Last updated 21 Feb 2025
Brief summary (registry, in English)
Observation of findings associated with AMD
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 23 Aug 2023
- Start date
- 15 Oct 2023
- Primary completion date
- 1 Feb 2025
- Lead sponsor
- OcuDyne, Inc.
- Diseases
- Macular degeneration
- NCT number
- NCT06015633
What you commit to
- Study type: Observational
- Planned participants: 50
- From 15 Oct 2023 to the primary completion date, 1 Feb 2025
- 1 site 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
- Any intraocular surgery (including lens replacement surgery) in the study eye, within 90 days of enrollment
- Aphakia or absence of the posterior capsule in the study eye (Note: Previous violation of the posterior capsule is also excluded unless it occurred as a result of yttrium aluminum garnet \[YAG\] laser posterior capsulotomy in association with prior posterior chamber intraocular lens implantation and at least 90 days prior to enrollment)
- Use of any investigational product or investigational medical device (i.e., not approved by FDA for the specific use) within 90 days prior to screening or anticipated use during the study
Other illness
- History of any retinal disease other than AMD in either eye
- History of vitrectomy in the study eye
- History of endophthalmitis
- History of idiopathic or autoimmune-associated uveitis in either eye
- Active inflammation or infection, including conjunctivitis, keratitis, or scleritis in either eye
- GA secondary to a condition other than AMD (e.g., Stargardt's disease, cone rod dystrophy, or toxic maculopathies such as Plaquenil maculopathy) in either eye
- Non-Ocular
- Acute or serious illness, in the opinion of the site investigator
- History of kidney failure or gadolinium toxicity
Other
- Ocular
- Spherical equivalent refractive error demonstrating \>6 diopters of myopia or an axial length \>26 mm in the study eye
- Trabeculectomy or aqueous shunt or valve in the study eye
- Presence of advanced guttae or visually significant keratopathy that would cause scattering of light or alter visual function in the study eye
- Women of childbearing potential who are pregnant or unwilling to use effective contraception for the duration of the study
Who the study is looking for
- At least 55 years of age at the time of consent
- Able to understand and provide written informed consent
- Sufficiently clear ocular media, adequate pupillary dilation, and adequate fixation to permit quality fundus imaging
- Able to cooperate with ophthalmic visual function testing and anatomic assessments
- Diagnosed with late-stage AMD in at least one eye. (if both eyes of an eligible subject meet inclusion criterion, the more advanced eye will receive primary eye assignment)
- Willing to have protocol specified genetic testing
- Willing to have head coil MRI/A (with contrast if deemed necessary)
Age in the registry: 55 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tel-Aviv Sourasky Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.