At Adelaide Eye and Retina Centre, we are actively involved in clinical research to help better patient outcomes and offer opportunities for patients to access novel therapeutics. Some of these therapies may be novel doses of currently available medications, new medications such as gene therapy and new medication delivery systems such as drops instead of injections.
If patients/participants are enrolled in studies their care is undertaken without cost and transport is often provided to and from visits. However the studies have very strict inclusion and exclusion criteria and so some patients/participants will not be eligible.
Some studies are observational, and others are interventional. We are currently recruiting for a number of studies which involve patients with intermediate AMD, nascent geographic atrophy, geographic atrophy, neovascular age-related macular degeneration, all forms of retinal vein occlusion (BRVO, CRVO and HRVO) and centre-involving diabetes-related macular oedema.
CURRENTLY RECRUITING TRIALS:
i-SIGHT2
Microcurrent Stimulation Therapy for Intermediate to Advanced Nonexudative Age-related Macular Degeneration (i-SIGHT2)
The goal of this clinical trial is to characterize the safety and effectiveness of the i-Lumen AMD transpalpebral microcurrent device and therapy in patients with intermediate to advanced nonexudative AMD.
- Presence of at least one large druse >125 microns in diameter due to AMD.
- BCVA letter score of 35 to 70 letters (inclusive) (Snellen equivalent 6/12 to 6/60 [20/40 to 20/200])
- Any implanted electrical device(s) including deep brain stimulator, hearing or visual implants (i.e., cochlear implant, auditory brainstem implant, retinal prostheses), and/or cardiac defibrillator/pacemaker.
- Implanted metallic device within 20 cm of the Treatment electrode (study eye(s)) and/or the grounding electrode (base of the hairline on the back of the neck).
- Uncontrolled diabetes, defined as glycated haemoglobin (HbA1c) >10% (13.3 mmol/L).
- Current tobacco or tobacco-related product use or history within the past 5 years of heavy smoking (defined as, on average, more than half a pack of cigarettes per day).
- Known severe allergy to fluorescein dye.
- Medical diagnosis of severe dry eye defined as requiring either artificial tears more than six (6) times a day or prescription drops (i.e., Restasis, Xiidra, or Cequa).
- History of seizure disorders, chronic migraines and/or cluster headaches.
- History and/or evidence of diabetic retinopathy in either eye as assessed by CF, fundus fluorescein angiography (FA), and OCT, to be confirmed by the Central Reading Centre.
- Other conditions which pre-dispose to chorioretinal atrophy such as inherited retinal dystrophy (i.e., Stargardt’s disease, Best’s disease, pattern dystrophy, central areolar choroidal dystrophy, etc.).
- History and/or evidence of exudative AMD in the study eye as assessed by CF, FA (or OCT-A ), and OCT, to be confirmed by Central Reading Centre.
- GA involving the foveal centre, as assessed by the Central Reading Centre using AF and OCT.
- History of intravitreal injections for GA (e.g., Syfovre or Izervay).
- Treatment with photobiomodulation (PBM) therapy or short pulse laser within 12 months prior to screening.
- Glaucoma requiring ≥3 medications and/or drops per day, or history of trabeculectomy.
- History of any kind of intraocular surgery, excluding cataract surgery performed ≥3 months from Screening.
- History of yttrium aluminium garnet (YAG) laser posterior capsulotomy <1 month from Screening.
- Visually significant cataracts and/or visually significant posterior capsular opacification.
- History of amblyopia.
4FRONT-2
Single Intravitreal (IVT) Injection of 4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration (4FRONT-2)
A Phase 3, Randomized, Double-Masked, Active-Controlled Trial of a Single Intravitreal Injection of 4D-150 in Adults With Macular Neovascularization Secondary to Age-Related Macular Degeneration
- ≥50 years of age at time of consent
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MNV secondary to nAMD with IVT anti-VEGF treatment history in the study eye, defined as EITHER:
- Treatment naïve, i.e. no prior IVT anti-VEGF therapy OR
- Previously treated with no more than 4 IVT anti-VEGF injections due to nAMD and received diagnosis of nAMD no more than 6 months prior to the Screening Visit AND documented evidence of anatomical improvement and visual stability/improvement in response to previous IVT anti-VEGF treatment, as determined by the Investigator
- Active subfoveal MNV or juxtafoveal/ extrafoveal MNV with a subfoveal component (where activity is defined as evidence of SRF, IRF, subretinal hyperreflective material, or leakage) identified by fluorescein angiography (FA) or spectral domain optical coherence tomography (SD-OCT) , in the study eye, at the Screening Visit confirmed by the Reading Center
- Demonstrated clinical response to aflibercept and functional stability in the study eye as confirmed by the Reading Center
- BCVA between 25 and 78 ETDRS letters, inclusive (20/320-20/32 Snellen equivalent) in the study eye at the Screening Visit
- CST less than or equal to 500 microns in the study eye at screening visit, confirmed by the central reading center
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Ocular Conditions:
- MNV due to causes other than nAMD in either eye (Fibrosis, atrophy, or subretinal hemorrhage in the foveal central subfield (1 mm diameter)
- History of retinal detachment in the study eye
- History of or presence of active inflammation in either eye
- Glaucoma or intraocular hypertension requiring more than 2 topical medications for control
Ocular Treatments/Interventions:
- Any prior or concomitant treatment for MNV or vitreomacular-interface abnormalities, other than allowed prior IVT anti-VEGF in the study eye
Systemic Conditions and Considerations:
- Major illness or major surgical procedure in the 28 days prior to the Screening Visit
- Uncontrolled blood pressure
- Acute coronary syndrome, myocardial infarction or coronary artery revascularization, cerebrovascular accident, transient ischemic attack within 6 months of the Screening Visit
- History of autoimmune condition that may predispose to the development of uveitis
Age-Related Macular Degeneration Benchmark Imaging Dataset (ABID)
This is a prospective, cross-sectional, multi-center, observational study to collect and develop a meticulously curated and diverse AMD benchmark dataset, featuring reference standard level 1 classification and comprehensive annotation of images.
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Inclusion Criteria:
- Participants greater than or equal to 50 years of age at time of signing Informed Consent Form
- Willing to comply with all study procedures and sign the Informed Consent Form (ICF)
- Individuals with normal healthy eyes or diagnosed with any stage of Age-Related Macular Degeneration (treatment naïve patients with early, intermediate, or late AMD). The diagnosis and eligibility review will be confirmed by Central Reading Center.
- Therapeutic treatment for any type of AMD, in either eye. Supplements, such as AREDS2 formula, are allowed.
- Unable to acquire adequate quality images, as evaluated by the Central Reading Center
- Severe vision loss requiring urgent surgery
- Contraindicated for acquiring retinal images due to narrow anterior chamber angles or hypersensitivity to light
- A systemic or ocular condition that in the opinion of the Investigator would preclude participation in the study
- Unwilling to sign informed consent form
- Currently or previously enrolled in an interventional AMD clinical trial
SIENNA
A Multicenter, Randomized, Double-Masked, Placebo-Controlled Phase 3 Study of the Efficacy, Safety, and Tolerability of Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
SANOFI – DFI18231
A Phase 1/2, Study to Evaluate the Safety, Tolerability, and Efficacy of One-time Intravitreal Dose of SAR446597 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration
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Adelaide Eye and Retina Centre
18 North Terrace, Adelaide.
We are located on the second floor.
18 North Terrace, Adelaide
Marion Eye and Retina Centre
530 Marion Road, Plympton Park.