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OpenTrials
Active, Not Recruiting

NCT Number: NCT06015633

Ocular, Vascular, and Genetic Findings in AMD Patients

Observation of findings associated with AMD

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

About this study

Explorational observation of ocular, vascular, and genetic findings in patients diagnosed with AMD

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

Ocular

  • History of any retinal disease other than AMD in either eye
  • Spherical equivalent refractive error demonstrating >6 diopters of myopia or an axial length >26 mm in the study eye
  • History of vitrectomy in the study eye
  • Any intraocular surgery (including lens replacement surgery) in the study eye, within 90 days of enrollment
  • History of endophthalmitis
  • Trabeculectomy or aqueous shunt or valve in the study eye
  • 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)
  • Presence of advanced guttae or visually significant keratopathy that would cause scattering of light or alter visual function in the study eye
  • 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

  • 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
  • Women of childbearing potential who are pregnant or unwilling to use effective contraception for the duration of the study
  • Acute or serious illness, in the opinion of the site investigator
  • History of kidney failure or gadolinium toxicity

Treatment and study plan

No intervention

Other

Observational only

Primary outcomes

  1. OCT-A

    Time frame: Baseline observation of incidence / correlation only

    OCT-A metrics in subjects with AMD

Secondary outcomes

  1. Genetic markers related to AMD

    Time frame: Baseline observation of incidence / correlation only

    Presence of 52 known AMD related genetic markers

  2. Magnetic Resonance Angiography

    Time frame: Baseline observation of incidence / correlation only

    Ophthalmic artery MRI / MRA results in subjects with AMD

Sponsors and collaborators

Lead sponsor

OcuDyne, Inc.

Industry

Registry information

Official study title

Exploration of Ocular, Vascular, and Genetic Findings Associated and Correlated with the Presence of Late-stage AMD

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 29, 2023
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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