Age-Related Macular DegenerationNCT05091476
OcuDyne System in the Treatment of AMD
A study testing OPTiC System in people with Age-Related Macular Degeneration, run by OcuDyne, Inc. at 2 sites in Argentina.
Trial summary
Feasibility of the OcuDyne OPTiC System in patients with late-stage non-exudative age-related macular degeneration. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- OPTiC System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesArgentina
- Study dates
- 27 Feb 2023to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be able to understand and provide informed consent on an Independent Ethics Committee (EC) approved informed consent form (ICF)
- Must be willing and able to return for scheduled treatment and follow-up examinations for up to a 7-month duration
- Adults at least 60 years of age at the time of consent
- Diagnosed with non-exudative Age-Related Macular Degeneration with current or previous evidence of at least one large drusen (measuring 125 microns or greater) and nascent geographic atrophy (nGA) or GA in the study eye
- ETDRS best corrected visual acuity (BCVA) letter score of less than 56 letters (Snellen equivalent of 20/80 or worse) in the study eye, which in the Investigator's judgment is caused by non-exudative age-related macular degeneration (AMD)
- The confirmed presence of ophthalmic artery (OA) stenosis (leading to the study eye).
Who cannot join
- OCULAR
- Any surgical intraocular treatment (including laser) within 3 months in the study eye.
- History of exudative AMD or Anti-Vascular Endothelial Growth Factor (anti-VEGF) injections within 6 months in the study eye.
- Presence of ocular media affecting visual acuity or the ability to visualize the retina in either eye (e.g., central corneal scarring, lens opacities along visual axis, posterior capsule opacification, etc.).
- History of chronic, recurring inflammatory eye disease in either eye (e.g., scleritis, uveitis, corneal edema, etc.)
- Presence of diabetic retinopathy in either eye.
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- Evidence of macular edema secondary to exudation in the study eye.
- History of amaurosis fugax, central or retinal artery or vein occlusion, anterior ischemic optic neuropathy (AION) or non-arteritic anterior ischemic optic neuropathy (NAION) or any diagnosis of a macular disease other than AMD such as Stargardt disease, cone rod dystrophy, angioid streaks, or toxic maculopathies such as Plaquenil maculopathy.
- Myopia > 6.0 Diopters (D) spherical equivalent (SE) or Axial Length ≥ 26.0 mm in the study eye.
- Presence of visually significant epiretinal membrane in the study eye.
- Participation in any eye-related drug or device clinical trial involving either eye within 90 days prior to enrolling in this study and/or during study participation.
- Non-Ocular
- Any condition that prohibits the use of intravenous contrast agents (e.g., renal insufficiency, previous anaphylactoid reaction to contrast material, treatment with nephrotoxic agents, etc.).
- Previous stroke, including ischemic, hemorrhagic or transient ischemic attack (TIA).
- Previous myocardial infarction (MI), including ST segment elevation (STEMI), non-ST segment elevation (NSTEMI) or coronary spasm/angina.
- Coronary or other intravascular percutaneous procedure, including balloon angioplasty, stent or filter placement within the last 6 months.
- Complete occlusion of the ophthalmic artery.
- Pacemaker, Cochlear, or neurostimulation implant.
- Presence of cranial aneurysm, clinically significant stenosis in common carotid artery or internal carotid artery, or tortuous vascular anatomy as seen on pre-procedural CT Angiogram that, in the clinical judgement of the investigator, represents an unreasonable risk to perform the intervention.
- Condition associated with increased bleeding risk including but not limited to: major surgical procedure or trauma within 30 days of screening; clinically significant gastrointestinal bleeding within 1 year of screening; known gastric or duodenal ulcer; history of intracranial or spinal bleeding; chronic hemorrhagic disorder; treatment with oral anticoagulant medications (e.g., Warfarin / non-vitamin K anticoagulants [NOACs] exclusionary; aspirin or clopidogrel allowed), known intracranial neoplasm, arteriovenous malformation, or aneurysm.
- Treatment with oral anticoagulant medications (e.g., Warfarin / non-vitamin K anticoagulants [NOACs] exclusionary; aspirin or clopidogrel allowed).
- Sustained and uncontrolled hypertension with systolic blood pressure > 180 mmHg.
- Diagnosis of moderate to severe symptomatic congestive heart failure (CHF) or chronic obstructive pulmonary disease (COPD)
- Diagnosis of connective tissue, demyelinating, autoimmune, or inflammatory diseases (e.g., lupus, rheumatoid arthritis, scleroderma, giant cell arteritis, multiple sclerosis, etc.).
- Intolerance of either pre- or post- procedure medication regimen.
- Pregnancy, lactation, or plans to become pregnant during participation in this clinical trial.
- Participation in any other non-eye related drug or device clinical trial within 30 days prior to enrolling in this study and/or during study participation.
- Other
- Use of facial fillers or paralytic drugs during study participation.
- Subject who, in the clinical judgement of the investigator, is not otherwise suitable for participation in the study for another clinical reason, as documented by the investigator.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Clinical Study to Evaluate the Safety and Feasibility of the OcuDyne System in the Treatment of Age-Related Macular Degeneration (AMD)
Feasibility of the OcuDyne OPTiC System in patients with late-stage non-exudative age-related macular degeneration.
Read the detailed description
This study evaluates the safety and feasibility of using the OcuDyne OPTiC System in patients with late-stage non-exudative age-related macular degeneration.
- Conditions
- Age-Related Macular Degeneration
- Being tested
- OPTiC System
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPTiC SystemDevice
OPTiC System procedure
| Study group | Role | What they receive |
|---|---|---|
| Eyes treated with the OPTiC System | Experimental | Eyes that OPTiC System treatment has been completed Receives: Device: OPTiC System |
| Fellow Eye | No intervention | Contralateral comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Procedural Complications \& Adverse Events
Measured: Intraoperative through Week 4 postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start27 Feb 2023
- Primary completion31 Jul 2024
- Study completion1 Oct 2024
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- OcuDyne, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luana R Wilbur, BS, Study director, OcuDyne VP, Clinical and Regulatory Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05091476
- Sponsor's protocol ID
- OC-1901AR
- Status last verified
- Feb 2025
- First submitted
- 12 Oct 2021
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Safety and Feasibility of the OcuDyne System in the Treatment of Age-Related Macular Degeneration (AMD)
- ClinicalTrials.gov ID
- NCT05091476
- Acronym / sponsor ID
- OC-1901AR
- Conditions
- Age-Related Macular Degeneration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- OcuDyne, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 25 Oct 2021 (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.
Feasibility of the OcuDyne OPTiC System in patients with late-stage non-exudative age-related macular degeneration.
Detailed description
This study evaluates the safety and feasibility of using the OcuDyne OPTiC System in patients with late-stage non-exudative age-related macular degeneration.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eyes treated with the OPTiC System | Experimental | Device: OPTiC SystemEyes that OPTiC System treatment has been completed |
| Fellow Eye | No intervention | –Contralateral comparator |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Must be able to understand and provide informed consent on an Independent Ethics Committee (EC) approved informed consent form (ICF)
- Must be willing and able to return for scheduled treatment and follow-up examinations for up to a 7-month duration
- Adults at least 60 years of age at the time of consent
- Diagnosed with non-exudative Age-Related Macular Degeneration with current or previous evidence of at least one large drusen (measuring 125 microns or greater) and nascent geographic atrophy (nGA) or GA in the study eye
- ETDRS best corrected visual acuity (BCVA) letter score of less than 56 letters (Snellen equivalent of 20/80 or worse) in the study eye, which in the Investigator's judgment is caused by non-exudative age-related macular degeneration (AMD)
Key exclusion criteria (30 listed)
- OCULAR
- Any surgical intraocular treatment (including laser) within 3 months in the study eye.
- History of exudative AMD or Anti-Vascular Endothelial Growth Factor (anti-VEGF) injections within 6 months in the study eye.
- Presence of ocular media affecting visual acuity or the ability to visualize the retina in either eye (e.g., central corneal scarring, lens opacities along visual axis, posterior capsule opacification, etc.).
- History of chronic, recurring inflammatory eye disease in either eye (e.g., scleritis, uveitis, corneal edema, etc.)
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 |
|---|---|---|
| OPTiC SystemOPTiC System procedure | Device | Eyes treated with the OPTiC System |
Primary outcome
Adverse Events
Time frame: Intraoperative through Week 4 postoperative
Procedural Complications \& Adverse Events
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 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 R Wilbur, BS study director
OcuDyne VP, Clinical and Regulatory Affairs
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OPTiC System in people with Age-Related Macular Degeneration, run by OcuDyne, Inc. at 2 sites in Argentina.
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 6 inclusion and 30 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: finished, as of the sponsor's last update on 13 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 2 sites in Argentina. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adverse Events (time frame: Intraoperative through Week 4 postoperative). 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 13 Feb 2025.