Age-Related Macular DegenerationNCT06015633
Ocular, Vascular, and Genetic Findings in AMD Patients
An observational study of Age-Related Macular Degeneration, run by OcuDyne, Inc. at 1 site in Israel.
Trial summary
Observation of findings associated with AMD Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Age-Related Macular Degeneration
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Oct 2023to 31 May 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with exudative or non-exudative late-stage age-related macular degeneration.
Who may be able to join
- 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)
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploration of Ocular, Vascular, and Genetic Findings Associated and Correlated with the Presence of Late-stage AMD
Observation of findings associated with AMD
Read the detailed description
Explorational observation of ocular, vascular, and genetic findings in patients diagnosed with AMD
- Conditions
- Age-Related Macular Degeneration
- Being tested
- No intervention
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Observational only
| Study group | Role | What they receive |
|---|---|---|
| Exudative AMD | Subjects that have at least one eye with a history of, or active, exudative age related macular degeneration Receives: Other: No intervention | |
| Non-exudative AMD | Subjects that have at least one eye with late stage non-exudative age-related macular degeneration (presence of geographic atrophy) Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
OCT-A
OCT-A metrics in subjects with AMD
Measured: Baseline observation of incidence / correlation only
Secondary outcomes (2)
Genetic markers related to AMD
Presence of 52 known AMD related genetic markers
Measured: Baseline observation of incidence / correlation only
Magnetic Resonance Angiography
Ophthalmic artery MRI / MRA results in subjects with AMD
Measured: Baseline observation of incidence / correlation only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start15 Oct 2023
- Primary completion1 Feb 2025
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OcuDyne, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luana Wilbur, BS, Study director, OcuDyne VP, Clinical and Regulatory Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06015633
- Sponsor's protocol ID
- OC-2301TV
- Status last verified
- Feb 2025
- First submitted
- 23 Aug 2023
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Ocular, Vascular, and Genetic Findings Associated and Correlated with the Presence of Late-stage AMD
- ClinicalTrials.gov ID
- NCT06015633
- Acronym / sponsor ID
- OC-2301TV
- Conditions
- Age-Related Macular Degeneration
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- OcuDyne, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 29 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observation of findings associated with AMD
Detailed description
Explorational observation of ocular, vascular, and genetic findings in patients diagnosed with AMD
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exudative AMD | – | Other: No interventionSubjects that have at least one eye with a history of, or active, exudative age related macular degeneration |
| Non-exudative AMD | – | Other: No interventionSubjects that have at least one eye with late stage non-exudative age-related macular degeneration (presence of geographic atrophy) |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with exudative or non-exudative late-stage age-related macular degeneration.
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionObservational only | Other | Exudative AMD, Non-exudative AMD |
Primary outcome
OCT-A
Time frame: Baseline observation of incidence / correlation only
OCT-A metrics in subjects with AMD
2 secondary outcomes
Genetic markers related to AMD
Time frame: Baseline observation of incidence / correlation only
Magnetic Resonance Angiography
Time frame: Baseline observation of incidence / correlation only
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luana Wilbur, BS study director
OcuDyne VP, Clinical and Regulatory Affairs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age-Related Macular Degeneration, run by OcuDyne, Inc. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OCT-A (time frame: Baseline observation of incidence / correlation only). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.