Clinical Trials
Strathfield Retina Clinic has a strong commitment to clinical research and actively supports new and innovative treatments for retinal diseases. Our dedicated research unit is currently involved in a number of international clinical trials and programs involving patients with Age-Related Macular Degeneration, Diabetic Macular Oedema and Retinal Vein Occlusions. These studies are pivotal in quantifying the outcomes of current management and support the potential for future treatments.
The practice has a wide-range of experience in clinical trials and recognise the importance of research to promote understanding of eye disorders, investigate new therapeutic agents and advise patients on the best available treatment options.
Some patients enrolled in trials have the benefit of accessing new and advanced treatments during the final stages of development, prior to market release.
SIENNA
A phase 3 study to evaluate the efficacy, safety and tolerability of subcutaneously administered Pozelimab in combination with Cemdisiran or Cemdisiran alone in participants with Geographic Atrophy.
- Inclusion: 50-85yrs, GA lesions 2.5-17.5mm^2, VA >6/24, willing to receive vaccinations
- Exclusion: history of/current MNV, Syfovre/Izervay within 6 months, cataract surgery or MIGS within 3 months, HbA1c >8%
CIRCLE
A phase 2b study to assess efficacy and safety of FWY003 in patients with geographic atrophy
- Inclusion: >50yrs, GA lesions 2.5-17.5mm^2, VA >6/60, willing to receive vaccinations
- Exclusion: History of/active MNV, cataract surgery or vitreoretinal surgery within 3 months, stroke or myocardial infarction within 6 months, Syfovre/Izervay within 3 months
4FRONT-2
A phase 3 study of 4D-150 in adults with Macular Neovascularization secondary to age-related macular degeneration
- Inclusion: >50yrs, treated and treatment naive, diagnosed within 6 months, CST below 500 um, BCVA between 6/7.5-6/95
- Exclusion: Stroke, TIA or cerebrovascular accident within 6 months, Cataract surgery, YAG or glaucoma surgery within 3 months, Trabeculectomy, glaucoma tube/shunt
MALBEC
A phase 2/3 study to evaluate the efficacy and safety of EYE201/MK-8748 compared to Eylea 2mg in participants with Neovascular Age-related macular degeneration
- Inclusion: >50yrs, treatment naive, diagnosed within 21 days, VA between 6/7.5 and 6/95, fluid affecting the central subfield
- Exclusion: stroke or myocardial infarction within 180 days, active malignancy, cataract surgery, MIGS or YAG within 3 months, retinal detachment, vitrectomy, uveitis or glaucoma-filtering surgeries
Constance
Phase IV trial investigating the safety, efficacy and durability of Faricimab administered up to 24 weeks in the treatment of Wet Age-Related Macular Degeneration.
- Inclusion: 50yrs +, VA between 6/7.5 and 6/75, treatment naïve
- Exclusion: History of macular pathology unrelated to AMD. Cataract surgery of YAG within the last 3 months. History of stroke within the last 6 months.
OTX SOL-R
A phase 3 study evaluating the efficacy and safety of Intravitreal OTX-TKI (Axitinib Implant) in the treatment of Neovascular Age-Related Macular Degeneration.
- Inclusion: 50yrs +, VA better than 6/60, CST <350um, treatment naïve or previously treated with up to 3 previous injections
- Exclusion: Uncontrolled glaucoma. Cataract surgery, laser or ocular infection within the last 3 months. Previous treatment with pegcetacoplin.
Archer II
A Phase 3 study investigating the efficacy and safety of intravitreal injections of ANX007 for Geographic Atrophy.
- Inclusion: 50yrs +, VA between 6/7.5 - 6/30, GA lesions 2.5-17mm^2
- Exclusion: Uncontrolled glaucoma or surgery for glaucoma, previous IVT injections in designated study eye, cataract surgery <3 months ago
Brunello
A Phase 2/3 study evaluating the efficacy and safety of EYE103 compared to Ranibizumab in treatment of Diabetic Macular Edema.
- Inclusion: 18yrs old+, treatment naïve or previously treated AMD <3years from diagnosis, VA 6/9.5-6/95, CST >325um, Hba1c <12%
- Exclusion: Renal failure. Active PDR. Recent stroke / heart attack / cataract or glaucoma surgery. Previous vitrectomy, glaucoma filtering surgery, uveitis or retinal detachment. Presence of ocular inflammation / ERM / pathological myopia / amblyopia.
Poyang
A Phase III study evaluating the safety and efficacy of Faricimab in myopic CNV.
- Inclusion: 18yrs old+, Treatment naive myopic CNV, VA 6/12-6/95, AXL >26.0mm, Myopia -6D or worse
- Exclusion: Previous intravitreal injections, laser, vitrectomy, glaucoma surgery, corneal transplant. Presence of ocular inflammation, CSR, schisis, ERM, previous retinal tear
KK DMO
A Phase III study of KHK4951 eyedrops to explore safety and efficacy in the treatment of diabetic macula oedema.
- Inclusion: 18yrs+, treatment naïve or previously treated DMO <3 years from diagnosis, VA 6/9.5-6/60, CST 325um-500um, HbA1c <11%, BP <140/90.
- Exclusion: AntiVEGF within 12 weeks, History of stroke / TIA / blood clots / bleeding disorders. Proliferative diabetic retinopathy. Previous macular laser, PDT laser, glaucoma surgery, corneal transplant.
KK AMD
A Phase II study of KHK4951 eye drops to explore safety and efficacy in the treatment of wet age related macular degeneration.
- Inclusion: 50yrs old+, treatment naive or previously treated AMD <3years from diagnosis with active leakage at the fovea. VA 6/9.5-6/60, CST <450um, BP under 150/100
- Exclusion: AntiVEGF within 12 weeks, History of stroke / TIA / blood clots / bleeding disorders. Previous macular laser, PDT laser, glaucoma surgery, corneal transplant. Subretinal hemorrhage / fibrosis / atrophy that involves the fovea.
Phoenix
A phase III study of Tinlarebant to explore safety and efficacy in the treatment of geographic atrophy (GA).
- Inclusion: 60-85 yrs old, VA 6/24 or better, GA lesion 1-10mm^2 (foveal involvement <1.25mm^2 in either eye) BMI <40, HBa1c <8%
- Exclusion: Presence of DMO, macular disease or other retinal vascular conditions, Medications containing Vitamin A or Retinoids that can’t be stopped.
Parasol
A phase IIb study of intravitreal gene therapy treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
- Inclusion: 60yrs old+, GA lesion 2.5-17.5mm^2 (non subfoveal), VA 6/45 or better
- Exclusion: Previous CNV, presence of diabetic retinopathy, CSR, retinal vascular disease, macular hole, macular fibrosis. Previous macular laser, PDT laser, vitrectomy, glaucoma surgery, corneal transplant.
Insite
Treat & Extend versus Fixed dosing with Faricimab for management of Diabetic Macular Oedema (DMO).
- Inclusion: Foveal involving DMO, CST >325um, VA 6/7.5-6/120. Hba1c <10%
- Exclusion: Previous macular laser, antiVEGF within 12 weeks, DMO persisting for more than 2 years.
Furgghorn
Assessing the efficacy and durability of intravitreal Faricimab in patients currently treated for neovascular age-related macular degeneration (nAMD).
- Inclusion: CNV diagnosed <3 years ago, most recent treatment within last 3 months, active CNV affecting central subfield, VA 6/120 or better
- Exclusion: Presence of geographic atrophy / fibrosis, vitreous hemorrhage.
QUASAR
A phase III study of the efficacy and safety of Aflibercept 8 mg in Macular Oedema secondary to Retinal Vein Occlusion.
Coast
A phase III, multicentre, double-masked, randomised study to evaluate the efficacy and safety of Intravitreal OPT-302 in combination with Aflibercept, compared with Aflibercept alone, in participants with neovascular age-related macular degeneration (nAMD).
GALE
A phase III, open-label, multicenter, Oaks extension study to evaluate the long-term safety and efficacy of Pegcetacoplan in subjects with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Onward
A phase II, double-masked, placebo-controlled, dose range finding study of Danicopan in patients with Geographic Atrophy (GA) secondary to age-related macular degeneration (AMD).
EnGAge
A long-term extension study for Participants enrolled in Parasol.