Clinical Trials

Eye Surgery Associates (ESA) has extensive experience in clinical trials from Phases I-IV, including first-in- human trials. Over the past 15 years, we have been involved with more than 50 investigator-initiated and pharmaceutical or biotech sponsored studies, including age-related macular degeneration, retinal disease, glaucoma, uveitis, cornea and have recently been licensed to participate in our first GMO study.

We are experienced in measuring ophthalmic endpoints in ophthalmic studies as well as other indications, especially oncology.

Our convenient locations

ESA is networked across four sites in metropolitan Melbourne (East Melbourne, Malvern, Doncaster and Vermont South).

Our Database

ESA maintains a searchable database containing over 200,000 unique ophthalmology patient records, which can assist with ophthalmic patient recruitment.

Currently Recruiting Studies

We welcome clinical trials organisations/sponsors to consider ESA when choosing a research partner who can provider ophthalmology services.

Collaboration

We collaborate with CROs, universities, hospitals, trial sites and sponsors, including functioning as an Australian site for global studies.

Our Team

Our experienced research team includes ophthalmologists, accredited orthoptists/testers, study coordinators, administrative support, equipment management and IT support staff who provide research services across our four sites. We provide ophthalmic diagnostic testing, assessments, procedures and surgery for trials and understand the compliance and regulatory requirements involved. Many of the 19 highly qualified ophthalmologists at ESA hold appointments at public hospitals and universities, cover a broad range of sub-specialties, with interests in both ophthalmic devices and pharmaceuticals. Our experienced orthoptists (ophthalmic technicians) are proficient in using advanced ophthalmic equipment, with training in new techniques and certification available if needed. We can provide both masked and unmasked investigators and ensure investigator and staff back-up to maintain service continuity and address any adverse ophthalmic events. All members of our research team are GCP certified, and our administrative support staff is equipped to create source documents if necessary.

Ophthalmic Testing Capabilities

We provide comprehensive ophthalmic diagnostic testing, assessments, intravitreal and subretinal injections, laser treatments and surgical implantation of medical devices, with a thorough understanding of compliance and regulatory requirements. Additional tests can usually be accommodated if your protocol requires a service that is not listed. For further information, please contact our Clinical Trials team.

Click here to view Ophthalmic Testing Capabilities

We welcome clinical trial organisations/sponsors to consider ESA when choosing a research partner who can provide ophthalmology services. For further information please contact our clinical trials team and A/Prof Mack, who leads the clinical trials services at ESA on
trials@eyesurgery.com.au

Completed Ophthalmic Studies

Novartis Pharmaceuticals: RIVAL STUDY

Development of new geographic atrophy in patients with neovascular (wet) age-related macular degeneration: a comparison of ranibizumab and aflibercept.

Abbvie, 1924-701-007

A Prospective, Multicenter Clinical Trial Designed to Evaluate the Safety and Effectiveness of the XEN45 Glaucoma Treatment System in Patients with Angle Closure Glaucoma

Alcon, CTK378-E001 (CAPELLA)

Capella 3D Eye model data pilot study

Allergan, 1920240-093 (ATHENA)

A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients with Open-Angle Glaucoma or Ocular Hypertension

Ophthalmic monitoring for trial sites

Theratocular Biotek, TO-01C101

A 3-Part, First-in-human, Double-Blind, Randomized, and Placebo-Control Study Assessing the Safety, Tolerability, and Efficacy of TO-O-1001 Ophthalmic Solution in Healthy Subjects and in Patients with Open-Angle Glaucoma or Ocular Hypertension

Autobahn Therapeutics, ABX-002-1902

A Phase 1 Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of ABX-002 in Healthy Adult Subjects

Eucure (Beijing) Biopharma, YH002004

A multicenter, open-label, phase I dose escalation study to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of YH002 in combination with YH001 in subjects with advanced solid tumors

Adagene, ADG126-1001

A First-in-Human (FIH), Open-Label, Phase 1/2 Dose Escalation and Expansion Study of ADG126, ADG126 in Combination with Toripalimab, and ADG126 in Combination with ADG106 in Patients with Advanced/Metastatic Solid Tumors

BeLite Bio, LBS-008-CT06A Phase 1b

Open-Label, Parallel Single-Dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Tinlarebant in Elderly Healthy Volunteers

Adagene, ADG116-1003

A Phase 1, Open-Label, Dose Escalation Study of ADG116 in Patients with Advanced/Metastatic Solid Tumors

Immunogen, IMGN853-0419 (PICCOLO)

A Phase 2, Single Arm Study of Mirvetuximab Soravtansine in Recurrent Platinum-Sensitive, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers with High Folate Receptor-Alpha Expression

Q32 Bio, ADX-914-001

A Double-Blind, Phase 1, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of ADX-914 in Healthy Participants

Immunogen, IMGN853-0416 (MIRASOL)

A Randomized, Open-label, Phase 3 Study of Mirvetuximab Soravtansine vs. Investigator’s Choice of Chemotherapy in Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers with High Folate Receptor-Alpha Expression

GlaxoSmithKline, 212669

Phase I, Open-Label, Multi-Centre Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of GSK2798745 after 28 Day (with an optional additional 8 Week) Repeat Oral Administration to Adults with Diabetic Macular Edema

GlaxoSmithKline, 208887

A Phase I/II, Randomized, Open-label Platform Study Utilizing a Master Protocol to Study Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination with Anti-Cancer Treatments in Participants with Relapsed/Refractory Multiple Myeloma (RRMM) – DREAMM5.

Gilead Sciences, GS-US-389-5545

A Phase 1 Study to Evaluate the Pharmacokinetics and Pharmacodynamics of GS-9688 upon Co-administration with a Representative Proton Pump Inhibitor or H2-Receptor Antagonist

BeiGene, BGB-A317-A445-101

Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumour Activity of the Anti-OX40 Agonist Monoclonal Antibody BGB-A445 in Combination With the Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors.

Stargazer Pharmaceuticals, STG-001-1b

An Open-label Phase 1b Cross-over Pharmacokinetic Relative Bioavailability Study Comparing 2 Formulations of STG-001 in Healthy Subjects

Acelink Therapeutics, AL01211-101

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose in Healthy Volunteers and Autosomal Dominant Polycystic Kidney Disease Subjects Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AL01211

Emerald Health Pharmaceuticals, EHP-101-01

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Food Effect of Single Ascending Doses and Multiple Ascending Doses of EHP-101 in Healthy Subjects

Stargazer Pharmaceuticals, STG001-1

A Randomized, Double-Masked (Sponsor-Open), Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Escalating Single Doses and Multiple Ascending Doses of STG-001 in Healthy Subjects