Alberta Retina Consultants we recognize the personal impact of vision loss. We are committed to treating various retinal conditions but are also equally committed to research to ensure that our patients receive the best possible care.
We work with different types of sponsors and studies from pharmaceutical companies to University-based Research Networks and provide assistance with studies to other centers such as the Cross Cancer Institute.
Research Coordinator Heather can be reached via email at research@alberta-retina.com for questions regarding our current studies.
Our active studies include:
Shore-enrollment closed
Full Title: A Phase 3, Multicentre, Double-masked, Randomised Study to Evaluate the Efficacy and Safety of Intravitreal OPT-302 in Combination with Ranibizumab, Compared with Ranibizumab Alone, in Participants with Neovascular Age-related Macular Degeneration (nAMD)
Principle Investigator at ARC: Dr. Mark Greve
Purpose and Rationale:
There is a high unmet medical need for more effective treatments in participants with sub-optimal responses to current treatments for neovascular AMD. Since the addition of 2.0 mg OPT-302 to 0.5 mg ranibizumab provided a statistically significant superior gain in vision compared to 0.5 mg ranibizumab with sham in study OPT-302-1002, with anatomical improvement and no emergent safety issues over and above those expected with intravitreal administration of ranibizumab, it is appropriate to progress the development of OPT-302 and establish efficacy.
It is intended that this program will provide sufficient evidence of efficacy and safety to progress to a marketing application.
Objective: To determine the efficacy of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 0.5 mg ranibizumab, in participants with neovascular AMD.
Patients will be randomized at Baseline to 1 of 3 treatment arms
Arm A: 0.5 mg ranibizumab with OPT-302 2.0 mg intravitreal injections; standard dosing x 96 weeks
Arm B: 0.5 mg ranibizumab with OPT-302 2.0 mg intravitreal injections; extended dosing x 96 weeks
Arm C: 0.5 mg ranibizumab with sham intravitreal injections; dosing x 96 weeks
Inclusions/Exclusion Population:
- Patients 50 years of age or older
- Patients with a new diagnosis of wet-AMD and are intravitreal treatment naive
- Patients with BCVA (in the study eye) between 60 and 25 letters, determined at screening appointment.
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 and Rationale:
The long-term, stable expression of the ABBV-RGX-314 TP following a 1-time gene therapy treatment for nAMD could potentially reduce the treatment burden of currently available antiVEGF therapies while maintaining vision with a favorable benefit:risk profile. The current study is therefore intended to evaluate the safety and efficacy of ABBV-RGX-314 in participants with nAMD relative to an active comparator (aflibercept 2 mg [0.05 mL]) administered by intravitreal injection.
Objective: To evaluate the noninferiority of ABBV-RGX-314 relative to aflibercept from baseline to BCVA at Week 54. Mean change from baseline in BCVA to Week 54 based on the ETDRS score (noninferiority to the active control)
Patients will be randomized at Baseline to 1 of 3 treatment arms
Arm 1: ABBV-RGX-314 (dose 1)
Arm 2: ABBV-RGX-314 (dose 2)
Arm 3: Aflibercept control
Inclusions/Exclusion Population:
- Patients 50-89 years of age
- Patients with a diagnosis of wet-AMD of 4 years or less
- Patients with BCVA (in the study eye) between 78 and 40 letters, determined at appointment date.
- Must be pseudophakic (cataract surgery completed)
Insite
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