OcuDyne System in the Treatment of AMD
Primary Purpose
Age-Related Macular Degeneration
Status
Recruiting
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
OPTiC System
Sponsored by
About this trial
This is an interventional treatment trial for Age-Related Macular Degeneration
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
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.
- 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.
Sites / Locations
- Buenos Aires MaculaRecruiting
- ENERIRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Eyes treated with the OPTiC System
Fellow Eye
Arm Description
Eyes that OPTiC System treatment has been completed
Contralateral comparator
Outcomes
Primary Outcome Measures
Adverse Events
Procedural Complications & Adverse Events
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05091476
Brief Title
OcuDyne System in the Treatment of AMD
Official Title
A Clinical Study to Evaluate the Safety and Feasibility of the OcuDyne System in the Treatment of Age-Related Macular Degeneration (AMD)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 25, 2022 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OcuDyne, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Eyes treated with the OPTiC System
Arm Type
Experimental
Arm Description
Eyes that OPTiC System treatment has been completed
Arm Title
Fellow Eye
Arm Type
No Intervention
Arm Description
Contralateral comparator
Intervention Type
Device
Intervention Name(s)
OPTiC System
Intervention Description
OPTiC System procedure
Primary Outcome Measure Information:
Title
Adverse Events
Description
Procedural Complications & Adverse Events
Time Frame
Intraoperative through Week 4 postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
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.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luana R Wilbur, BS
Phone
858-442-7178
Email
lwilbur@ocudyne.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luana R Wilbur, BS
Organizational Affiliation
OcuDyne VP, Clinical and Regulatory Affairs
Official's Role
Study Director
Facility Information:
Facility Name
Buenos Aires Macula
City
Buenos Aires
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agustina Goyret
Phone
+541123192313
Email
agoyret@bamsite.com.ar
Facility Name
ENERI
City
Buenos Aires
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matias Correa
Phone
541149747373
Email
mcorrea@bioscienceweb.com
12. IPD Sharing Statement
Learn more about this trial
OcuDyne System in the Treatment of AMD
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