Research.

Our research studies include: locally lead clinical and surgical retina studies, clinical trials involving new drug therapies and novel gene therapy, studies with University-based research networks and with centers such as the Cross Cancer Institute.

Our current clinical trial participation include

Ascent

Insite

Parasol

Archer II

Research Coordinator Heather can be reached via email at research@alberta-retina.com for questions regarding our current studies.

Ascent

Full Title:

A Randomized, Partially Masked, Controlled, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of RGX-314 Gene Therapy in Participants with nAMD

Principle Investigator at ARC: Dr. Mark Greve

Purpose:

ABBV-RGX-314 (also known as RGX-314) is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (wet AMD). Wet AMD is characterized by loss of vision due to new, leaky blood vessel formation in the retina. Wet AMD is a significant cause of vision loss in the United States, Europe and Japan, with up to 2 million people living with wet AMD in these geographies alone. Current anti-vascular endothelial growth factor (VEGF) therapies have significantly changed the landscape for treatment of wet AMD, becoming the standard of care due to their ability to prevent progression of vision loss in the majority of patients. These therapies, however, require life-long intraocular injections, typically repeated every four to 12 weeks in frequency, to maintain efficacy. Due to the burden of treatment, patients often experience a decline in vision with reduced frequency of treatment over time. ABBV-RGX-314 is being developed as a potential one-time treatment for wet AMD.

This randomized, partially masked, controlled, Phase 3 clinical study will evaluate the efficacy and safety of ABBV-RGX-314 gene therapy in participants with nAMD. The study will evaluate 2 dose levels of RGX-314 gene therapy relative to an active comparator. The primary endpoint of this study is mean change in best-corrected visual acuity (BCVA) of ABBV-RGX-314 relative to aflibercept. Approximately 660 participants who meet the inclusion/exclusion criteria, will be enrolled into one of 3 arms.

Inclusion Criteria:

Age ≥ 50 years and ≤ 89 years
An ETDRS BCVA letter score between ≤ 78 and ≥ 40 in the study eye
Diagnosis of subfoveal choroidal neovascularization (CNV) secondary to AMD in the study eye previously treated with anti-VEGF
Must be pseudophakic (at least 12 weeks postcataract surgery) in the study eye
Willing and able to provide written, signed informed consent for this study
Participants must have demonstrated a meaningful response to anti-VEGF therapy at study entry

Exclusion Criteria:

CNV or macular edema in the study eye secondary to any causes other than AMD
Subfoveal fibrosis or atrophy in the study eye
Any condition in the investigator's opinion that could limit VA improvement in the study eye
Active or history of retinal detachment, or current retinal tear that cannot be treated, in the study eye
Advanced glaucoma or history of secondary glaucoma in the study eye
Myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months.
History of intraocular surgery in the study eye within 12 weeks prior to randomization
History of intravitreal therapy in the study eye, such as intravitreal steroid injection or investigational product, other than anti-VEGF therapy, in the 6 months prior to Screening Visit 1.
Prior treatment with gene therapy.

Must be pseudophakic (cataract surgery completed)

The Human Gene Transfer (HGT) Institutional Biosafety Committee (IBC) 2025 Meeting Minutes

View Here

Insite

ENROLLMENT CLOSED

Full Title:

Treat & Extend versus Fixed Dosing with Faricimab for Management of Diabetic Macular Edema: A Pragmatic, Multi-center, Open-label, Randomized, Controlled Trial

Principle Investigator at ARC: Dr. Matthew Tennant

Purpose and Rationale:

The Treat & Extend versus Fixed Dosing with Faricimab for Management of Diabetic Macular Edema: A Pragmatic, Multi-center, Open-label, Randomized, Controlled Trial will be a definitive, multinational pragmatic trial assessing a 4-week extension interval against the standard of a fixed dosing regimen. The trial design will optimize the durability and efficacy of the novel bi-specific antibody, faricimab, and will help establish a clinically useful, easy to replicate T&E strategy aimed at achieving optimal visual outcomes with an individualized treatment regime while minimizing treatment burden.

A key aspect of this trial design is to assess treatment intervals beyond the maximum 16-week regimen that has been tested in the pivotal Phase III trials. This trial will assess a maximal interval of every 24 weeks, which will provide new evidence in terms of the potential use of longer treatment intervals of faricimab in DME management.

Currently there is a lack of consensus around a T&E re-treatment algorithm for DME management. Many of the larger DRCR.net studies have employed a PRN strategy with complicated monitoring and re-treatment algorithms that are difficult to replicate in clinical practice. Fixed dosing regimens have limited clinical value due to the high treatment burden and costs that are not reproducible in real world practice. A recently completed meta-analysis on treatment algorithms for DME management demonstrated a significant evidence gap in the field in terms of visual outcome and anatomic outcome data beyond year one with T&E strategy in DME. Moreover, every T&E trial thus far has used a different re-treatment algorithm which significantly limits clinical applicability. The current trial proposal will generate impactful new data in an area of significant evidence gap, specifically: what is potentially the best DME management algorithm?

Objective:

To determine if a 4-week pragmatic T&E regime up to Q24W with faricimab versus fixed dosing at Q8W with faricimab produces noninferior outcomes (mean change in best corrected visual acuity (3.9 letter non-inferiority margin)) from baseline at week 100 in the study eye, for patients diagnosed with CI-DME.

Patients will be randomized at Baseline to 1 of 2 treatment arms

Arm 1 (Fixed Dosing-Control Arm)
Arm 2 (Treated and Extend-Intervention Arm)

Inclusions/Exclusion Population:

Patients 18 years of age or older
Patients with a diagnosis of Diabetes Mellitus (type 1 or 2) and Diabetic Macular Edema
Patients with BCVA (in the study eye) between 80 and 20 letters, determined at appointment date.
Hemoglobin A1c must be< 10% within 2 months prior to date of randomization.

Parasol

ENROLLMENT CLOSED

Full Title:

A Phase 2b, Randomized, Double-masked, Multicenter, Doseranging, Sham-Controlled Clinical Trial to Evaluate Intravitreal JNJ-81201887 (AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Agerelated Macular Dege

Principle Investigator at ARC: Dr. Mark Seamone

Purpose and Rationale:

The drug being studied is a gene therapy called JNJ-81201887. The human body contains trillions of cells. Each one of these cells contain DNA, which holds instructions that help the body develop and function. DNA can be used to produce proteins, which have many different functions in the body. DNA that contains instructions to make a protein is known as a gene. Gene therapy is based upon technology that may treat or cure disease by replacing, adding, or turning off a gene or protein in the cells. JNJ-81201887 is being studied to learn more about how it can slow the progression of geographic atrophy by increasing the amount of a certain anti-inflammatory protein, called soluble CD59, that normally exists in your eye. This effect of increasing CD59 will last for many years and potentially for life.

Patients will be randomized at Baseline to 1 of 3 treatment arms

Arm 1: JNJ-81201887 (dose 1)
Arm 2: JNJ-81201887 (dose 2)
Arm 3: Placebo/Sham

Inclusions/Exclusion Population:

Patients 60 years of age or older
Patients with a diagnosis of Dry AMD with non-subfoveal geographic atrophy
Patients with BCVA (in the study eye) of 35 letters or better, determined at appointment date.
Cannot have wet AMD in either eye

Archer II

ENROLLMENT CLOSED

Full Title:

A Phase 3, Multicenter, Randomized, Parallel-Group, Double-Masked, 2-Arm, Sham Controlled Study of the Efficacy, Safety, and Tolerability of ANX007 Administered by Intravitreal Injection in Patients with Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

Principle Investigator at ARC: Dr. David Ehmann

Purpose

The primary purpose of the study is to determine if IVT injections of ANX007 every month reduce vision loss in participants with GA secondary to age-related macular degeneration (AMD).

Patients will be randomized at Baseline to 1 of 3 treatment arms

Arm 1: ANX007-Participants will receive ANX007 IVT injections every month during the 24-month treatment period.
Arm 2: Sham Group-Participants will receive Sham IVT injections every month during the 24-month treatment period.

Inclusion Criteria:

Diagnosis of GA of the macula secondary to AMD as determined by the Investigator and confirmed by the independent Central Reading Center.

Exclusion Criteria:

Geographic atrophy due to other causes than AMD such as Stargardt disease, cone-rod dystrophy, pathologic myopia, or toxic maculopathies (for example, plaquenil maculopathy) in either eye.

NOTE: Other protocol-defined inclusion and exclusion criteria may apply.